Manager, Industrial and Employee Relations

Safety Manager – North America Michigan

Safety Manager - Automotive North America - Houston

QC Laboratory Manager

Manager II – Quality & Reliability Engineer

Manager – ADL GMP

Reference Standard Coordinator

Process Mechanic – Sterile Filling & Packaging

Facility Mechanic

Engineering Supervisor

Responsibilities: Grievance &amp; Compliance Leadership: <ul><li>Lead end-to-end employee misconduct investigations (preliminary and detailed), ensuring fairness, consistency, and legal compliance across all cases.</li><li>Own full disciplinary lifecycle: recommend actions, approve issuance of show cause/warning/dismissal letters, and maintain robust, auditable records.</li><li>Drive periodic compliance audits across contract labor suppliers (security, canteen, uniform vendors) and ensure timely corrective action on non-conformities.</li><li>Conduct due diligence and performance reviews of foreign operator agencies; submit data-driven recommendations for contract renewals or terminations.</li></ul> Policy &amp; Process Ownership: <ul><li>Manage centralized document control for all HR policies, procedures, and operational guidelines — ensuring accessibility, version control, and alignment with evolving legal standards.</li><li>Design and deliver compliance training programs for managers and employees, covering HR policy, performance management, and labor law essentials.</li><li>Act as the go-to subject matter expert on employment law, IR best practices, and grievance resolution frameworks.</li></ul> Union Engagement &amp; Strategy: <ul><li>Lead plants transition into a unionized environment: educate leaders and HR on union dynamics, negotiation frameworks, and collaborative engagement models.</li><li>Build and sustain a constructive union relationship — balancing business needs with employee representation through regular dialogue, transparency, and mutual respect.</li><li>Anticipate union-related risks and opportunities; advise leadership proactively on IR positioning and response strategies.</li><li>Drive union readiness programs, including leadership coaching, communication protocols, and scenario planning.&nbsp;</li></ul> Canteen Management: <ul><li>Lead vendor governance for contract labor and canteen operations. Monitor service levels, hygiene, and employee satisfaction; drive timely audits, feedback loops, and improvements.</li></ul> Hostel &amp; Foreign Worker Management (End-to-End): <ul><li>Manage full lifecycle of foreign worker operations: manpower planning, documentation, immigration processes, hostel inspections, welfare coordination, and compliance with regulatory and internal standards.</li><li>Ensure foreign workers are treated with dignity and respect; champion human rights standards and ethical labor practices.</li><li>Coordinate with embassies, Ministry of Home Affairs, Department of Immigration, and labor agencies to ensure seamless processes and timely resolution of issues.</li><li>Oversee hostel living conditions, safety, and welfare programs; act as the primary point of contact for foreign worker concerns.</li></ul> Compliance Audits &amp; Risk Management: <ul><li>Lead and coordinate audits related to labor compliance, human rights, and ethical sourcing across all third-party providers.</li><li>Ensure the plant is audit-ready at all times; track and close findings with urgency and rigor.</li><li>Stay current on evolving labor regulations and proactively adjust policies and practices to mitigate risk</li></ul> Requirements: <ul><li>Bachelors degree in Human Resource Management, Business Administration, Industrial Relations, or related discipline.</li><li>7–10 years of HR experience, with deep exposure to industrial relations, employee relations, labor law, and HR compliance—preferably in a manufacturing, unionized, or FMCG environment.</li><li>Proven track record of managing complex disciplinary cases, union negotiations, and IR matters with sound judgment and integrity.</li><li>Strong working knowledge of Malaysian labor law, Employment Act, Industrial Relations Act, and related regulations.</li><li>Advanced proficiency in Microsoft Office (Excel, Word, PowerPoint); able to prepare reports, dashboards, and present findings with clarity.</li><li>Familiar with HR systems, documentation best practices, and audit standards.</li><li>Excellent stakeholder management and interpersonal skills; able to influence, negotiate, and build trust across all levels—from frontline employees to senior leaders.</li></ul>

Responsibilities: Safety Program Development <ul><li>Design and maintain comprehensive safety policies and procedures tailored to operations.</li><li>Conduct regular reviews and updates of safety protocols to align with evolving regulations.</li></ul> Risk Assessment &amp; Mitigation <ul><li>Perform workplace hazard assessments and risk analyses.</li><li>Develop strategies to mitigate risks and prevent workplace injuries.</li></ul> Compliance Management <ul><li>Ensure compliance with OSHA, EPA, and other relevant regulations.</li><li>Prepare documentation and reports for audits and inspections.</li></ul> Training &amp; Employee Engagement <ul><li>Conduct safety training sessions for employees, contractors, and visitors.</li><li>Promote a culture of safety awareness and responsibility across the organization.</li></ul> Incident Investigation &amp; Reporting <ul><li>Lead investigations into workplace accidents and near-misses.</li><li>Create detailed reports, identify root causes, and implement corrective actions.</li></ul> Monitoring &amp; Inspections <ul><li>Perform routine inspections of equipment, facilities, and workspaces.</li><li>Identify non-compliance issues and recommend corrective measures.</li></ul> Emergency Preparedness <ul><li>Develop and oversee emergency response plans.</li><li>Coordinate drills and ensure readiness for potential crises.</li></ul> Collaboration &amp; Communication <ul><li>Work closely with leadership, HR, and operations teams to integrate safety into all aspects of the business.</li><li>Serve as the primary point of contact for safety-related inquiries.</li><li>Assist with security-related initiatives and collaborate with relevant teams to ensure a secure work environment.</li></ul> Requirements: <ul><li>Education: Bachelor’s degree in Occupational Health &amp; Safety, Environmental Science, Industrial Engineering, or a related field. Professional certifications like CSP (Certified Safety Professional) or OSHA certification are preferred.</li><li>Experience: Minimum 5 years of experience in a safety management role, preferably in the automotive or manufacturing industry.</li><li>Skills:</li><li>Strong knowledge of safety regulations and standards</li><li>Excellent problem-solving and analytical skills</li><li>Effective communication and leadership abilities</li><li>Technical Proficiency: Familiarity with safety management systems and software</li></ul> Work Environment <ul><li>Primarily office-based with frequent visits to production floors and facilities</li><li>Occasional travel may be required to other company locations or external sites</li></ul>

Responsibilities: Safety Program Development <ul><li>Design and maintain comprehensive safety policies and procedures tailored to operations.</li><li>Conduct regular reviews and updates of safety protocols to align with evolving regulations.</li></ul> Risk Assessment &amp; Mitigation <ul><li>Perform workplace hazard assessments and risk analyses.</li><li>Develop strategies to mitigate risks and prevent workplace injuries.</li></ul> Compliance Management. <ul><li>Ensure compliance with OSHA, EPA, and other relevant regulations.</li><li>Prepare documentation and reports for audits and inspections.</li></ul> Training &amp; Employee Engagement <ul><li>Conduct safety training sessions for employees, contractors, and visitors.</li><li>Promote a culture of safety awareness and responsibility across the organization.</li></ul> Incident Investigation &amp; Reporting <ul><li>Lead investigations into workplace accidents and near-misses.</li><li>Create detailed reports, identify root causes, and implement corrective actions.</li></ul> Monitoring &amp; Inspections <ul><li>Perform routine inspections of equipment, facilities, and workspaces.</li><li>Identify non-compliance issues and recommend corrective measures.</li></ul> Emergency Preparedness <ul><li>Develop and oversee emergency response plans.</li><li>Coordinate drills and ensure readiness for potential crises.</li></ul> Collaboration &amp; Communication <ul><li>Work closely with leadership, HR, and operations teams to integrate safety into all aspects of the business.</li><li>Serve as the primary point of contact for safety-related inquiries.</li><li>Assist with security-related initiatives and collaborate with relevant teams to ensure a secure work environment.</li></ul> Requirements: <ul><li>Education: Bachelor’s degree in Occupational Health &amp; Safety, Environmental Science, Industrial Engineering, or a related field. Professional certifications like CSP (Certified Safety Professional) or OSHA certification are preferred.</li><li>Experience: Minimum 5 years of experience in a safety management role, preferably in the automotive or manufacturing industry.</li></ul> Skills: <ul><li>Strong knowledge of safety regulations and standards</li><li>Excellent problem-solving and analytical skills</li><li>Effective communication and leadership abilities</li><li>Technical Proficiency: Familiarity with safety management systems and software</li></ul> Work Environment <ul><li>Primarily office-based with frequent visits to production floors and facilities</li><li>Occasional travel may be required to other company locations or external sites</li></ul>

Responsibilities: <ul><li>Establish and lead the QC laboratory, including analytical and microbiological functions, supporting sterile injectable IV bag production.</li><li>Oversee all testing activities: raw material, in-process, finished product, and stability testing, in compliance with applicable cGMP and regulatory requirements.</li><li>Support and manage startup, qualification, calibration, and maintenance of all QC lab equipment and systems to ensure operational readiness and regulatory compliance.</li><li>Develop and enforce strong data integrity practices, including procedures, training, and routine monitoring of laboratory systems and documentation.</li><li>Build and maintain a scientifically sound, compliant laboratory environment capable of supporting high-potent APIs and controlled substances.</li><li>Hire, train, and mentor laboratory personnel to ensure technical capability and compliance with laboratory and safety procedures.</li><li>Implement and maintain robust systems for documentation (SOPs, protocols, specifications), investigations (OOS, deviations), and CAPA management.</li><li>Lead and support analytical method transfers, validations, and technical investigations in collaboration with cross-functional teams.</li><li>Oversee microbiology operations, including environmental monitoring, utility sampling, sterility testing, and microbiological release activities.</li><li>Ensure inspection readiness and represent QC in audits, PAIs, and regulatory inspections.</li><li>Collaborate cross-functionally with QA, Validation, Engineering, Manufacturing, and Regulatory to ensure alignment and compliance across the site.</li><li>Ensure adherence to safety protocols, especially in handling high-potent materials and controlled substances.</li><li>Establish laboratory KPIs and drive continuous improvement in performance, compliance, and operational efficiency.</li></ul> Requrements: Qualifications / Experience: <ul><li>Bachelor’s or Master’s degree in Chemistry, Microbiology, or related scientific discipline.</li><li>8–12 years of pharmaceutical QC laboratory experience, including 3–5 years in a leadership role.</li><li>Experience with sterile injectable manufacturing, high-potent APIs, and controlled substances is required.</li><li>Deep knowledge of cGMP, FDA, ICH, USP, and applicable global regulatory standards.</li><li>Experience with startup or greenfield sites and laboratory buildouts preferred.</li><li>Demonstrated experience with method transfer, validation, and technical problem-solving.</li><li>Experience establishing equipment lifecycle programs, including qualification and maintenance.</li></ul> Skills / Competencies: <ul><li>Strong leadership with ability to build and develop high-performing lab teams.</li><li>Excellent technical knowledge in analytical and microbiological testing.</li><li>Deep understanding of data integrity principles and enforcement of best practices.</li><li>Proficiency in laboratory systems (LIMS, CDS, ELN) and equipment qualification.</li><li>Ability to manage complex lab operations in a startup environment.</li><li>Strong project management, documentation, and communication skills.</li><li>Commitment to patient safety, quality, and regulatory compliance.</li></ul>

Responsibilities: 1. Team Leadership <ul><li>Manage, mentor, and develop a team of Quality and Reliability Engineers.</li><li>Assign projects and tasks based on individual strengths and organizational priorities.</li><li>Conduct performance evaluations and provide coaching for continuous improvement.</li><li>Lead cross-functional problem-solving teams to address customer quality issues, reduce DPPM, and lower the cost of poor quality.</li></ul> 2. Quality Assurance <ul><li>Develop and implement robust quality control processes and procedures.</li><li>Oversee customer quality audits and ensure compliance with our client quality policies and customer requirements.</li><li>Analyze quality data and metrics to identify trends and areas for improvement.</li></ul> 3. Failure Analysis <ul><li>Lead structured failure investigations (e.g., fault tree analysis) to determine root causes and corrective actions.</li><li>Coordinate product testing related to customer-reported issues.</li><li>Serve as the primary quality interface with customers on escalations, reliability matters, and compliance.</li></ul> 4. Project Management <ul><li>Lead quality and reliability improvement projects from concept through completion.</li><li>Collaborate cross-functionally with Sales, Engineering, and Operations to align on customer quality objectives.</li><li>Support supplier reviews, customer audits, and on-site technical support.</li><li>Conduct periodic business reviews with key customers on DDN quality and reliability performance.</li></ul> 5. Continuous Improvement <ul><li>Identify opportunities for process optimization, cost reduction, and improved efficiency.</li><li>Implement Lean and Six Sigma methodologies to drive continuous improvement.</li><li>Collaborate with Engineering and Sales to share the DDN strategic quality roadmap and strengthen customer partnerships.</li></ul> 6. Reporting and Communication <ul><li>Prepare and present reports on quality and reliability metrics to senior leadership.</li><li>Communicate effectively with internal and external stakeholders on quality matters and escalations.</li><li>Provide Voice of the Customer (VoC) feedback to Product Management, Engineering, and Manufacturing to mitigate risks.</li></ul> 7. Tactical Initiatives <ul><li>Proactively identify and remove roadblocks affecting quality and customer satisfaction.</li><li>Drive urgency and accountability across teams to meet customer expectations.</li><li>Bridge communication between customers and internal teams to ensure timely problem resolution.</li></ul> Requirements: Qualifications and Experience <ul><li>Education: Bachelor’s degree in Electrical, Mechanical, or related Engineering field; Master’s degree preferred.</li><li>Experience: Minimum 7 years in Quality Assurance or Reliability Engineering, including at least 3 years in a managerial or global capacity.</li></ul> Technical Skills: <ul><li>Strong knowledge of Quality Management Systems (QMS), Statistical Process Control (SPC), Gage R&amp;R, and reliability tools.</li><li>Experience with failure analysis using structured methodologies (e.g., fault tree analysis).</li></ul> Certifications: <ul><li>Six Sigma Black Belt, ASQ Certified Quality Engineer (CQE), or equivalent preferred.</li></ul> Soft Skills: <ul><li class="ql-indent-1">Strong leadership and team development skills.</li><li class="ql-indent-1">Excellent problem-solving, communication, and interpersonal abilities.</li><li class="ql-indent-1">Demonstrated customer interface experience in data center interconnect technology.</li><li class="ql-indent-1">Executive-level presence with the ability to influence across all levels of the organization.</li></ul>

Role Description: <ul><li>The Manager –ADL, GM P is responsible for leading analytical development activities within a GMP-regulated environment, ensuring robust method development, validation, and transfer for pharmaceutical products.</li><li>This role plays a critical part in supporting product development, regulatory submissions, and commercial manufacturing by providing accurate and compliant analytical data.</li></ul> Responsibilities <ul><li>Lead and manage a team involved in method validation, method transfer, and postproduction studies (Freeze Thaw analysis, Photostability studies, Dilution studies, RLD Characterization, etc.) for 505b(2) and generic ANDAs.</li><li>Troubleshoot and resolve challenges during method validation and method transfer of new products from R&amp;D to manufacturing sites.</li><li>Support regulatory filings and respond to analytical function queries.</li><li>Ensure compliance with cGLP within the ADL GMP function.</li><li>Provide support during quality inspections by regulatory agencies at manufacturing plants.</li><li>Timely closure of LIR, NCR, CCN, CAPA and ensure implementation of corrective and preventive actions.</li><li>Ensure timely compliance with Pharmacopoeia updates.</li><li>Mentor, coach, and develop team members for task execution and personal growth.</li><li>Collaborate with external partners (CRO/CMO) for analytical testing execution.</li><li>Work cross-functionally with project management, regulatory affairs, formulation development, manufacturing, and quality control teams.</li></ul> Requirements: <ul><li>Education: Ph.D. OR MPharm.</li><li>Experience: 3–4 years of team handling experience.</li></ul> Skills Required: <ul><li>Strong knowledge of analytical method validation, method transfer, Pharmacopoeia compliance, cGLP, and documentation practices.</li><li>Sound understanding of analytical techniques with good learning agility.</li><li>Excellent technical writing and computer skills for data recording, protocol/report generation, and presentations.</li><li>Strong coordination, relationship management, and ability to work in multicultural teams.</li><li>Effective communication and team management skills.</li><li>Knowledge of latest quality and regulatory requirements.</li><li>Ability to delegate effectively and take autonomous decisions.</li><li>Critical thinking skills for problem-solving and decision making.</li></ul>

Responsibilities: Sample Management <ul><li>Performs QC reference standard/chromatographic column receipt, processing, distribution for testing and storage.</li><li>Performs QC reference standard reconciliation and disposal.</li><li>Tracks inventory of reference standards in the lab.</li><li>Uses laboratory software for reference standard, chromatographic column management.</li><li>Verifies accuracy of labeling/documentation provided with reference standards.</li><li>Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.</li><li>Coordinates, with lab management, in-house qualification of reference standards. Submit samples to the appropriate lab groups for testing.</li><li>Create and maintain reports including quality data trending, informational spreadsheets, laboratory log spreadsheets.</li><li>Compile a list of necessary laboratory supplies specifically reference standards, contacting vendors to obtain quotes.</li><li>Uses the purchasing system to procure reference standards and laboratory supplies.</li><li>Provide status updates to QC management and other departments regarding the status of reference standard inventory.</li><li>Maintain a safe work environment by following standards and procedures and complying with legal regulations.</li></ul> Lab Equipment <ul><li>Maintains, operates equipment and instruments supporting reference standard processing.</li><li>Provides general laboratory support such as routine instrument cleaning/preventative. maintenance, reference standard/sample receiving, chemical inventory, document filing and housekeeping.</li><li>Works with internal resources to maintain lab in an optimal state. Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.</li><li>Under close supervision, learns to troubleshoot basic instrument problems.</li></ul> Investigations <ul><li>Escalates any trends/events to the QC Lab Manager.</li><li>Escalates any reference standard documentation issues to the QC Lab Manager.</li><li>With guidance, participates in OOS/OOT/NOE and other investigations.</li><li>Assists, as and when needed, scientists working in the laboratory.</li><li>May assist in drafting, editing, and reviewing SOPs.</li></ul> Training <ul><li>Maintains assigned training records current and in-compliance.</li><li>May assist in the training of laboratory staff.</li></ul> Compliance <ul><li>Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.</li><li>Documents accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.</li><li>Follows internal processes related to controlled substances.	continuous.</li></ul> Safety <ul><li>Follows EH&amp;S procedures to ensure a safe work environment.</li><li>Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS.</li></ul> Requirements: Education &amp; Experience <ul><li>College graduate, preferably in a Science related field.</li><li>Laboratory experience related to sample management preferred.</li></ul> Knowledge <ul><li>Basic knowledge of reference standard/sample management in a laboratory environment.</li><li>Some knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Competency in Microsoft Office Suite.</li><li>Proficiency with computers.</li></ul> Skills &amp; Abilities <ul><li>Ability to display and analyze data in a logical manner.</li><li>Good verbal and written communication skills as well as good computer skills.</li><li>Attention to details and accurate record keeping.</li><li>Establish and maintain cooperative working relationships with others.</li><li>Solid organizational skills.</li><li>Ability to take initiative, set priorities and follow through on assignments.</li></ul> Physical Requirements	 <ul><li>Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals.</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.</li><li>Specific visions abilities are required by this job include close vision and color vision.</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.</li></ul>

Responsibilities: <ul><li>Perform preventive and corrective maintenance on sterile IV bag fillers, isolators, compounding equipment, sterilizers, component prep equipment, automated inspection machines, and secondary packaging systems.</li><li>Support equipment setup, calibration, and changeover in accordance with production schedules, maintenance plans, site SOPs, and cGMP requirements.</li><li>Assist in the installation, commissioning, and qualification of new sterile processing equipment, support equipment, and secondary packaging equipment.</li><li>Troubleshoot mechanical issues in real-time to minimize downtime while maintaining aseptic conditions and operator safety.</li><li>Ensure proper gowning, cleanliness, and contamination control practices when working in classified cleanroom environments.</li><li>Document all maintenance activities accurately in maintenance logs, work orders, and computerized maintenance management systems (CMMS).</li><li>Collaborate with Engineering, Manufacturing, and Quality to support equipment investigations, deviations, and continuous improvement initiatives.</li><li>Follow all safety procedures, including lockout/tagout, confined space, and PPE use; actively contribute to a culture of workplace safety and compliance.</li><li>Maintain spare parts inventory, tools, and maintenance supplies in an organized and audit-ready condition.</li><li>Participate in training and cross-functional activities to support plant startup and readiness for regulatory inspections.</li></ul> Requirements: <ul><li>High school diploma or technical certificate required, Associate’s degree in a mechanical or technical field preferred.</li><li>3+ years of experience as a mechanic or technician in a pharmaceutical, biotech, or sterile manufacturing environment.</li><li>Experience with isolator-based sterile filling equipment and cleanroom protocols is highly desirable.</li><li>Strong mechanical aptitude and experience with pumps, valves, conveyors, pneumatic systems, and packaging machinery.</li><li>Solid electrical and controls experience with automated systems, inspection machines, robotics, and camera systems highly preferred.</li><li>Working knowledge of cGMP, aseptic techniques, and safety regulations (OSHA, FDA, EU Annex 1).</li><li>Ability to read and interpret mechanical drawings, equipment manuals, and SOPs.</li><li>Familiarity with CMMS platforms and basic computer skills (e.g., Microsoft Office).</li><li>Self-motivated with strong attention to detail, problem-solving skills, and the ability to work independently or in a team.</li><li>Willingness to work flexible hours, including weekends or off-shifts during production or commissioning activities.</li></ul> Work Environment: <ul><li>Hands-on role in a cleanroom-based pharmaceutical manufacturing facility with strict safety and aseptic requirements.</li><li>Requires frequent gowning, standing, and work in confined or classified areas.</li><li>Fast-paced startup environment, requiring adaptability, initiative, and a collaborative mindset.</li><li>Occasional lifting of heavy tools or parts; use of ladders, lifts, and hand tools required.</li></ul>

Responsibilities: <ul><li>Perform preventive and corrective maintenance, troubleshooting, and repairs on facility infrastructure and critical utilities, including HVAC systems for cleanroom environment, compressed air and vacuum systems, clean utilities (WFI, purified water, clean steam), boilers, chillers, temperature control units, and effluent water treatment equipment.</li><li>Support equipment setup, calibration, qualification, and creation of maintenance plans of facility utilities and equipment.</li><li>Conduct round and inspection to monitor system performance and proactively address issues.</li><li>Ensure proper gowning, cleanliness, and contamination control practices when working in classified cleanroom environments.</li><li>Document all maintenance activities accurately in maintenance logs, work orders, and computerized maintenance management systems (CMMS).</li><li>Collaborate with Engineering, Manufacturing, and Quality to support equipment investigations, deviations, and continuous improvement initiatives.</li><li>Follow all safety procedures, including lockout/tagout, confined space, and PPE use; actively contribute to a culture of workplace safety and compliance.</li><li>Maintain spare parts inventory, tools, and maintenance supplies in an organized and audit-ready condition.</li><li>Participate in training and cross-functional activities to support plant startup and readiness for regulatory inspections.</li><li>Provide technical support of production activities during absence of production support team members or when bandwidth is insufficient.</li></ul> Requirements:﻿ <ul><li>High school diploma or technical certificate required, Associate’s degree in a mechanical or technical field preferred.</li><li>3+ years of experience as a mechanic or technician maintaining utilities or facilities infrastructure in a pharmaceutical, biotech, or regulated manufacturing environment.</li><li>Experience with pharmaceutical manufacturing equipment and cleanroom protocols is highly desirable.</li><li>Strong troubleshooting skills for mechanical, electrical, and control system issues.</li><li>Familiarity with building management systems (BMS) and alarm monitoring systems.</li><li>Solid electrical and controls experience with automated systems, inspection machines, robotics, and camera systems highly preferred.</li><li>Understanding of cGMP, contamination control, and safety regulations (OSHA, FDA, EU Annex 1).</li><li>Ability to read and interpret mechanical drawings, equipment manuals, and SOPs.</li><li>Familiarity with CMMS platforms and basic computer skills (e.g., Microsoft Office).</li><li>Self-motivated with strong attention to detail, problem-solving skills, and the ability to work independently or in a team.</li><li>Willingness to work flexible hours, including weekends or off-shifts during production or commissioning activities.</li></ul> Work Environment: <ul><li>Hands-on role in a regulated, sterile pharmaceutical manufacturing facility with strict safety and aseptic requirements.</li><li>Requires frequent gowning, standing, and work in confined or classified areas.</li><li>Fast-paced startup environment, requiring adaptability, initiative, and a collaborative mindset.</li><li>Occasional lifting of heavy tools or parts; use of ladders, lifts, and hand tools required.</li><li>Physical requirements include lifting climbing ladders, electrical troubleshooting, and working with hand and power tools</li></ul>

Role Description: <ul><li>The Engineering Supervisor leads a team of skilled mechanics and technicians responsible for the maintenance, troubleshooting, and reliability of facility infrastructure, clean utilities, laboratory systems, and pharmaceutical production equipment at our new sterile injectable manufacturing site.</li><li>This individual will play a key leadership role in coaching, mentoring, and developing technical staff, while ensuring all maintenance activities are performed safely, efficiently, and in compliance with cGMP and regulatory requirements.</li><li>This is a pivotal role in a startup manufacturing environment, requiring strong leadership, technical depth, and a commitment to operational excellence and safety.</li></ul> Responsibilities: <ul><li>Supervise and develop a team of mechanics and technicians supporting facilities, utilities, lab and production equipment. Additional oversight of contractors will be expected.</li><li>Coach, train, and mentor team to build technical depth and promote a culture of ownership and continuous improvement.</li><li>Lead daily planning, prioritization, and execution of maintenance and reliability activities.</li><li>Conduct performance reviews, skill assessments, and development planning for direct reports.</li><li>Lead the maintenance, calibration, and repair of critical systems including HVAC, compressed air, WFI, clean steam, Nitrogen generation, isolators, fillers, automated inspection and leak detection equipment, automated secondary packaging equipment, lab systems, stability chambers, site infrastructure, and the Building Management System (BMS).</li><li>Ensure all activities are conducted in compliance with cGMP, safety regulations, maintenance plans and SOPs.</li><li>Support commissioning, qualification (IQ/OQ/PQ), and startup activities for new systems and equipment.</li><li>Drive proactive and preventive maintenance through CMMS system utilization and performance tracking.</li><li>Ensure good documentation practices and data integrity so all maintenance records are accurate, complete, and auditable.</li><li>Enforce a culture of safety focusing on EHS compliance, including Lockout/Tagout, confined space entry, Arc flash protection, and chemical safety protocols.</li><li>Support audits and inspections by regulatory agencies and internal quality teams.</li><li>Analyze equipment performance and maintenance data to identify trends, root causes, and opportunities to reduce downtime and increase reliability.</li><li>Collaborate with engineers, production, and quality teams to improve reliability and maintainability of equipment.</li><li>Manage spare parts strategy and implement inventory management process.</li></ul> Requirements: Qualifications/Experience: <ul><li>Associate or bachelor’s degree in engineering, Facilities Management, Industrial Technology, or related field (or equivalent experience).</li><li>Minimum 5+ years of experience in pharmaceutical, biotech, or regulated manufacturing environment, with 2+ years in a supervisory or team lead role.</li><li>Strong technical knowledge of clean utilities, facility systems, secondary packaging and aseptic manufacturing equipment.</li><li>Experience supervising or mentoring maintenance personnel.</li><li>Experience in controlled substance and high potent product environment desired.</li></ul> Skills/Competencies: <ul><li>Working knowledge of cGMPs, regulatory expectations, and CMMS systems (e.g., Blue Mountain, SAP PM, Maximo, etc.)</li><li>Strong organizational, communication, and leadership skills.</li><li>Demonstrated commitment to safety, compliance, and team development.</li><li>Excellent interpersonal, communication, and problem-solving skills.</li><li>Comfortable working in a fast-paced, evolving environment where agility and adaptability are key.</li><li>Strong leadership presence with demonstrated ability to build high-performing teams and compliance culture.</li><li>Effective communication, collaboration, and influencing skills across multiple stakeholders.</li></ul>

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21 laboratory investigations Jobs found

Manager, Industrial and Employee Relations

Safety Manager – North America Michigan

Safety Manager - Automotive North America - Houston

QC Laboratory Manager

Manager II – Quality & Reliability Engineer

Manager – ADL GMP

Reference Standard Coordinator

Process Mechanic – Sterile Filling & Packaging

Facility Mechanic

Engineering Supervisor

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21 laboratory investigations Jobs found

Manager, Industrial and Employee Relations

Safety Manager – North America Michigan

Safety Manager - Automotive North America - Houston

QC Laboratory Manager

Manager II – Quality & Reliability Engineer

Manager – ADL GMP

Reference Standard Coordinator

Process Mechanic – Sterile Filling & Packaging

Facility Mechanic

Engineering Supervisor

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