Manager, Industrial and Employee Relations

Safety Manager – North America Michigan

Safety Manager - Automotive North America - Houston

Project Manager Engineer

QC Laboratory Manager

Operations Manager

Supply Chain Analyst lll

Supervisor – Quality and Reliability Engineer

Head of Supply Chain & Storage

Validation Manager

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: Project Timeline: <ul><li>Identify and align projects goals and scope with PJM and PM, and breakdown tasks of tooling/process developments and qualification</li><li>Make/align tooling development and qualification timeline, assign tasks to Ops team include tooling development, materials purchase</li><li>Track and manage core team to execute project progress based on committed project schedule</li></ul> Project Cost: <ul><li>Lead Ops to simulate sample cost and production cost to achieve project landing zone target, lead Ops to optimize launch cost to the best</li><li>Budget and control scrap cost though leverage design and manufacturing process to meet project target during NPI phase</li></ul> Project Execution: <ul><li>Guide capacity planning, materials sourcing and manpower to support all builds in the plant.</li><li>Oversee the progression of tooling/process development, identify bottleneck and issues, organize Ops team to improve those bottleneck and issues.</li><li>Oversee risks assessment in project execution, stay interlock with PJM to make multination plan and conduct the planned activities in Ops.</li><li>Finalize the Safe Launch plan for the appropriate mix of product, tool capability and demand with the approval of the PjM, Quality, MDPE, and PjE. a. Lead Safe Launch team meetings to ensure successful HVM startup and manufacturing process qualification for attainment of required metrics for successful G5 handoff.</li><li>Align the budget with the Ops team with the tooling list provided by MPDE-A, control total capital spending against CER.</li><li>Lead and coordinate line setup to conduct LVM sample builds and coordinate HVM tool builds.</li><li>Lead Ops to make ramp up plan, include materials, operations and tool capacity ramp up, ensure manufacture team take over production control smoothly after G5.</li></ul> Product Sustaining: <ul><li>Product migration, as a receiving or sending leader to execute product move in or move out, including project timeline, investment, cost control, machine/material/manpower preparation, safety stock, safe launch, etc.</li><li>Lead product capacity analysis and expand it through re-investment per estimation.</li></ul> Requirements: <ul><li>Bachelor’s degree, engineering background is better</li><li>PMP certification preferred</li><li>At least 5 years related working experience in project management, 1~2 years’ experience in connector/cable/cable assembly is better</li><li>Fluent oral and written/reading in English</li><li>Experience in IT Project Manager, Data Center Business or digital networking project is an advantage.</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: EH&amp;S (Environment, Health &amp; Safety): <ul><li>Promote a culture of safety across the organization.</li><li>Ensure personnel adhere to established safety guidelines, procedures, and policies.</li><li>Implement lessons learned from security incidents at other facilities to maintain a safe environment.</li></ul> Quality: <ul><li>Promote a culture of quality throughout operations.</li><li>Ensure the operations team follows procedures in their respective areas.</li><li>Support audits from clients and regulatory entities.</li><li>Ensure compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).</li></ul> Production: <ul><li>Foster a respectful, dynamic, and challenging work environment.</li><li>Ensure the fulfillment of internal and external operational goals.</li><li>Uphold ethical and regulatory standards in all team behavior.</li><li>Develop and maintain a 5S culture to support efficient operations.</li></ul> Requirements: Competencies &amp; Skills: Core Competencies: <ul><li>Technical Learning: Demonstrated understanding and experience in intensive manufacturing processes.</li><li>Problem Solving: Subject Matter Expert (SME) in complex problem-solving; able to guide teams through solution analysis.</li><li>Ethics and Values: Uphold company values consistently, rewarding alignment and addressing deviations.</li><li>Action Oriented: Energetic and proactive in addressing operational challenges.</li></ul> Job-Specific Knowledge, Skills, and Abilities: <ul><li>Advanced computer skills (Microsoft Word, Excel, etc.).</li><li>Assertive communication and interpersonal skills.</li><li>Strong planning, organizational, implementation, and monitoring skills to ensure Gantt chart and goal achievement.</li><li>Blueprint interpretation and reading.</li><li>Ability to work effectively under pressure.</li><li>Delegation skills while maintaining accountability for results.</li><li>Customer service orientation.</li><li>Effective time management.</li><li>Knowledge of ISO 9002 and FDA-regulated manufacturing environments.</li><li>Experience promoting continuous improvement projects.</li></ul> Experience &amp; Educational Requirements: Experience: <ul><li>Managerial experience in operations/production.</li><li>Minimum 4 years as a senior supervisor, superintendent, or equivalent role in operations/production.</li><li>Approximately 60% office work and 40% time on manufacturing lines (36 months minimum).</li></ul> Education: <ul><li>Engineering degree or equivalent.</li><li>Master’s degree is desirable.</li></ul> Professional Training &amp; Certifications: <ul><li>Six Sigma Green Belt (preferred).</li></ul>

Responsibilities: <ul><li>Develop and implement an end-to-end Stocking Policy framework for both raw materials and finished goods for Malaysia and Philippines plants</li><li>Collaborate with cross-functional team and ensure alignment on the stocking policy</li><li>Align inventory strategies with modes of shipment to balance the cost, lead time, and service reliability</li><li>Adjust safety stock parameters based on shipment mode-specific lead times and transit variability</li><li>Work closely with the logistics team to ensure mode of shipment decisions support stocking and replenishment strategies</li><li>Recommend shipment mode adjustments in response to supply chain disruptions, capacity constraints, or changes in demand patterns</li><li>Conduct simulation analysis to provide the impact of changes to stocking policy and mode of shipment on leadtime, inventory, warehousing, and transportation cost</li><li>Ensure governance processes are in place to maintain data accuracy and consistency of stocking policy across Malaysia and Philippines plants and stakeholders</li><li>Drive continuous improvement initiatives to enhance stocking efficiency, optimize inventory, and cost, and enhance customer satisfaction</li><li>Support capability building by training supply chain teams on stocking policy concepts, tools, and governance processes</li><li>Follow up on block inventory and push owners to solve issues</li><li>Follow RMA closely on time</li></ul>&nbsp;Requirements: ·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Bachelor’s degree in supply chain, Operations Management, Industrial Engineering, or related field·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Minimum 10 years of experience in Supply Chain management.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5+ years working experience in Supply Chain roles – Materials Planning, Factory Planning, Finished Goods Planning·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Experience using SAP S/4 Hana, IBP, or equivalent planning tools is a must·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Strong analytical continuous improvement skills as well as a good understanding of data analytics capabilities·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Proven end-to-end Supply Chain experience, with a strong focus on strategic aspects rather than purely tactical or operational functions.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Expertise in stocking policies, logistics, and related processes.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Demonstrated involvement in Continuous Improvement initiatives and projects.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Strong cross-functional collaboration experience.Proven capability in implementing new processes and systems

Responsibilities: <ul><li>Manage the day-to-day activities of the team in a safe environment and be responsible for Health and Safety goals.</li><li>Deliver on all KPIs that help the business achieve its objectives.</li><li>Lead and drive QA initiatives within the functional area.</li><li>Provide quality input and support to Manufacturing, Engineering, Prototype, and Commercial functions.</li><li>Lead, coordinate, and maintain risk assessment documentation (e.g., FMEAs).</li><li>Investigate the root cause of quality issues and implement timely and effective corrective actions to prevent recurrence for both customer and internal issues.</li><li>Strategically lead new product introduction (NPI) and contract reviews from a QA perspective.</li><li>Prepare and update Operations procedures and associated documentation.</li><li>Overall responsibility for functional area GMP standards and compliance, including promoting quality awareness.</li><li>Establish inspection standards, sampling plans, and test methods.</li><li>Report quality metrics to management.</li><li>Develop strong links with customer organizations and other project stakeholders.</li><li>Review validation documentation for the functional area.</li><li>Perform and support internal and external audits to ISO and FDA requirements.</li><li>Actively contribute to the continuous improvement of the Quality Management System.</li><li>Supervise and provide direction to quality personnel.</li><li>Perform other tasks as directed by the Operations Quality Manager in line with company goals.</li></ul> Requirements: <ul><li>Level 8 degree in Science, Engineering, or related field.</li><li>Minimum of 5 years industry experience in a medical device manufacturing environment.</li><li>People management experience.</li></ul> Key Requirements <ul><li>Clear understanding of medical device quality systems and requirements, including measurement techniques.</li><li>Experience managing and leading a team.</li><li>Strong CAPA experience.</li><li>Strong root cause analysis and problem-solving skills.</li><li>Knowledge of FDA and ISO Quality systems for medical device companies is desirable.</li><li>Experience in new product introduction (NPI) and manufacturing process transfers is desirable.</li><li>Demonstrated excellent organizational skills and ability to work independently.</li><li>Excellent written and verbal communication skills.</li></ul>

Responsibilities: Strategic Planning and Leadership&nbsp; <ul><li>Formulate and implement comprehensive supply chain, distribution, and storage strategies aligned with Energy Business strategic objectives</li><li>Lead cross-functional teams to optimize supply chain performance and drive operational excellence</li><li>Develop and execute long-term capacity planning and infrastructure investment strategies</li><li>Establish key performance indicators (KPIs) and metrics to measure supply chain effectiveness</li><li>Present strategic recommendations and performance reports to executive leadership and board members</li></ul> Cross-Entity Synergy &amp; Integration&nbsp; <ul><li>Drive supply chain optimization and synergy realization across all entities within the Energy Business Unit</li><li>Identify and implement consolidated product procurement strategies, and integrated logistics solutions</li><li>Establish standardized processes, systems, and best practices across all Energy BU subsidiaries and divisions</li><li>Lead cross-entity collaboration to maximize economies of scale in sourcing, transportation, and storage operations</li><li>Develop integrated demand planning and capacity optimization strategies that leverage combined entity requirements</li><li>Create unified supplier management programs and negotiate enterprise-wide contracts to achieve cost savings and improved service levels</li><li>Implement shared infrastructure utilization strategies including storage facilities, distribution networks, and transportation assets&nbsp;</li></ul> Commercial Storage Infrastructure Management&nbsp; <ul><li>Lead the storage arm as a commercial enterprise, managing port-based storage facilities that serve both internal operations and external clients</li><li>Develop and implement commercial storage strategies to maximize revenue generation from third-party storage services while ensuring operational efficiency for internal requirements</li><li>Manage storage facility operations, capacity allocation, and infrastructure maintenance across multiple locations</li><li>Source for potential storage infrastructure to meet storage needs</li><li>Establish competitive pricing strategies, commercial terms, and service level agreements for third-party storage customers</li><li>Optimize storage utilization through dynamic capacity management, balancing internal operational needs with commercial rental opportunities</li><li>Build and maintain relationships with external petroleum companies, traders, and logistics providers seeking storage solutions</li><li>Ensure compliance with port authority regulations, maritime safety standards, and environmental requirements for commercial storage operations</li><li>Develop and execute expansion plans for storage infrastructure based on market demand analysis and return on investment projections</li><li>Coordinate with port authorities, shipping agents, and terminal operators to ensure seamless product handling and transfer operations</li><li>Establish quality assurance protocols for different petroleum products and maintain product segregation standards</li><li>Develop contingency plans for supply disruptions, emergency response procedures, and business continuity for both internal and external customers</li></ul> Supply Chain Management and Distribution Optimisation&nbsp; <ul><li>Oversee end-to-end supply chain operations including demand planning, procurement, logistics, and inventory management</li><li>Optimize sourcing strategies and supplier relationships to ensure reliable supply of petroleum products</li><li>Manage procurement processes, contract negotiations, and supplier performance evaluation</li><li>Implement demand forecasting methodologies and inventory optimization strategies</li><li>Ensure compliance with regulatory requirements and industry standards across all operations</li><li>Design and manage efficient distribution networks to across multiple market segments</li><li>Oversee transportation and logistics operations</li><li>Coordinate with sales teams to align distribution capabilities with market demands</li><li>Manage relationships with third-party logistics providers and distribution partners</li><li>Implement technology solutions to enhance distribution efficiency and customer service</li></ul> Team Leadership &amp; Development&nbsp; <ul><li>Build, lead, and develop a high-performing team</li><li>Foster a culture of continuous improvement, innovation, and operational excellence</li><li>Establish clear roles, responsibilities, and performance expectations for team members</li><li>Provide coaching, mentoring, and professional development opportunities</li><li>Manage organizational change and transformation initiatives&nbsp;</li></ul> Requirements: <ul><li>Bachelor’s degree in supply chain management or a business related field;</li><li>Masters degree (MBA or specialized Masters) is an added advantage.</li><li>Professional certifications (APICS, CSCMP, or equivalent) highly desirable;</li><li>Minimum 10 years of progressive and relevant experience in supply chain management, preferably in the energy, oil &amp; gas, or petrochemical industry</li><li>Over 5 years in senior leadership roles with P&amp;L responsibility</li><li>Proven track record of successfully managing complex, multi-site operations across multiple business entities or subsidiaries</li><li>Experience with storage facility management and petroleum product handling</li><li>Experience in strategic planning, business transformation, and operational optimization</li><li>Demonstrated success in driving synergies and integration across diverse business units or entities</li><li>xperience managing shared services organizations and cross-entity optimization initiatives</li></ul> Critical Success Factors&nbsp; <ul><li>Deep understanding of energy sector supply chains</li><li>Expertise in supply chain planning, demand forecasting, and inventory optimization</li><li>Knowledge of petroleum products, storage systems, port operations, and distribution infrastructure</li><li>Experience in commercial storage operations, terminal management, and third-party logistics services</li><li>Understanding of port authority regulations, maritime safety standards, and petroleum handling protocols</li><li>Proficiency in supply chain management software, ERP systems, and storage management platforms</li><li>Strong analytical skills with experience in data-driven decision making and commercial pricing strategies</li><li>Understanding of regulatory requirements and safety standards in the energy sector and port operations</li><li>Knowledge of petroleum product quality specifications, blending requirements, and contamination prevention</li></ul> Competencies&nbsp; <ul><li>Strong strategic thinking and business acumen with experience in multi-entity environments</li><li>Excellent communication and presentation skills</li><li>Proven ability to lead and influence cross-functional teams across different entities and geographies</li><li>Strong negotiation and relationship management skills</li><li>Change management and transformation leadership experience</li><li>Results-oriented mindset with focus on operational excellence and synergy realization</li><li>Experience in matrix management and leading virtual teams across organizational boundaries&nbsp;</li></ul>

Responsibilities: <ul><li>Serve as the site Validation SME, overseeing all validation activities, including process, cleaning, equipment, utility, and computer system validation.</li><li>Own and maintain the Validation Master Plan (VMP), ensuring alignment with regulatory expectations, site activities, and company objectives.</li><li>Develop, implement, and maintain the site validation lifecycle program, including process validation, performance qualification (PQ), and CPV.</li><li>Lead validation planning and coordination efforts for new equipment, systems, and process changes in collaboration with Engineering, Manufacturing, and Quality.</li><li>Manage validation project timelines and resource allocation, ensuring activities support commercial readiness and ongoing operations.</li><li>Review and approve validation protocols, reports, and risk assessments in compliance with FDA, EMA, ICH Q8-Q10, EU Annex 15, and company standards.</li><li>Support and participate in cross-functional risk assessments (e.g., FMEA) related to qualification and validation efforts.</li><li>Ensure validation documentation is complete, accurate, and audit ready.</li><li>Provide guidance and technical expertise during regulatory inspections, audits, and customer assessments.</li><li>Develop and maintain the site’s Continuous Process Verification (CPV) program to monitor validated state and process performance over time.</li><li>Define and monitor KPIs for validation program effectiveness and drive improvements in validation efficiency and compliance.</li><li>Train and mentor staff on validation principles and procedures to build internal capability across departments.</li><li>Ensure change control, deviation management, and CAPA processes integrate appropriately with validation and qualification requirements.&nbsp;</li></ul> Key Stakeholders: Internal: <ul><li>Site Quality, Manufacturing, and Engineering Teams</li><li>Technical Services, Supply Chain, and EHS</li><li>Validation Analysts and Support Staff</li><li>Corporate Validation and Quality Teams</li></ul> External: <ul><li>Regulatory Agencies (FDA, EMA, etc.)</li><li>Equipment and system vendors</li><li>Contract testing laboratories</li><li>Third-party auditors and certifying bodies</li></ul> Requirements; Qualifications / Experience: <ul><li>Bachelor’s degree in engineering, Life Sciences, Pharmacy, or related discipline; Master’s preferred</li><li>Minimum 10-12 years of experience in pharmaceutical or biotechnology validation, with at least 3 years in a leadership or SME role</li><li>Validation of sterile injectable equipment expertise required</li><li>Strong knowledge of FDA cGMPs, ICH Q8–Q10, EU Annex 15, and validation best practices</li><li>Experience with sterile injectable manufacturing, aseptic processes, utilities, and equipment qualification</li><li>Experience with controlled substances and high-potency compounds preferred</li><li>Proven experience supporting regulatory inspections and third-party audits</li><li>Experience with commissioning, qualification, and validation in a startup (greenfield) or expansion environment preferred </li></ul> Skills / Competencies: <ul><li>Strong technical writing and documentation review skills</li><li>Ability to manage multiple projects and prioritize in a fast-paced environment</li><li>Expertise in sterile systems, process validation, cleaning validation, and computer system validation</li><li>Excellent cross-functional communication, influencing, and collaboration skills</li><li>Strong analytical, risk-based decision-making, and problem-solving skills</li><li>Leadership presence with ability to coach and mentor others in validation principles</li><li>Commitment to data integrity, patient safety, and product quality</li></ul>

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58 contractor safety Jobs found

Manager, Industrial and Employee Relations

Safety Manager – North America Michigan

Safety Manager - Automotive North America - Houston

Project Manager Engineer

QC Laboratory Manager

Operations Manager

Supply Chain Analyst lll

Supervisor – Quality and Reliability Engineer

Head of Supply Chain & Storage

Validation Manager

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58 contractor safety Jobs found

Manager, Industrial and Employee Relations

Safety Manager – North America Michigan

Safety Manager - Automotive North America - Houston

Project Manager Engineer

QC Laboratory Manager

Operations Manager

Supply Chain Analyst lll

Supervisor – Quality and Reliability Engineer

Head of Supply Chain & Storage

Validation Manager

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