SUPV I (Supervisor-I) – Maintenance, Grade 5-4

Outlet Manager

HR Partner IV - RBA Lead

Mechanical Maintenance Engineer - Automation Technology

QA Associate II

Warehouse Technician

Chemist Data Reviewer

Staff Advanced Quality Engineer (Software)

Maintenance Engineer

Production Technician I

Responsibilities: <ul><li>Perform preventive, predictive and breakdown maintenance on R2R electroplating lines.</li><li>Maintain and troubleshoot WWTP systems and utility equipment, including pumps, filters, RO/UF, chillers, air scrubbers and evaporators.</li><li>Troubleshoot mechanical, electrical, pneumatic, hydraulic and PLC-related issues.</li><li>Support equipment installation, commissioning, modification and continuous improvement to improve reliability and productivity.</li><li>Ensure safety, environmental compliance, LOTO, maintenance documentation and RCA/corrective actions.</li></ul> Requirements: <ul><li>3–7 years of hands-on maintenance experience in manufacturing/industrial environments.</li><li>Diploma/ITI/Technical Certification in Mechanical Engineering.</li><li>Experience with electroplating operations and Reel-to-Reel (R2R) plating lines.</li><li>Experience in WWTP and utility equipment such as air scrubbers, evaporators, chillers and AHUs.</li><li>Hands-on troubleshooting knowledge across mechanical, electrical, pneumatic, hydraulic and PLC-controlled systems.</li></ul>

Responsibilities: <ul><li>Manage the implementation of Food and Beverage standards in the outlet ensuring that staff take corrective actions as necessary in adherence to Jumeirah policies and standards.</li><li>Monitor the profitability of the outlet to provide recommendations and/or solutions to improve problem areas and assist with implementing such corrective measures.</li><li>Develop and maintain positive working relationships with others, support team to reach common goals, and listen and respond appropriately to the concerns of other Colleagues.</li><li>Ensure adherence to quality expectations and standards; and identify, recommend, develop, and implement new ways to increase organizational efficiency, productivity, quality, safety, and/or cost-savings.</li><li>Consistently monitor the quality of food and beverages and service offered to guests and escalate any major problems/ complaints to senior management to ensure high service quality as per Jumeirah group quality standards.&nbsp;</li><li>Actively seeks, collates, reviews and shares Guest feedback regarding food quality, service, and overall satisfaction and takes appropriate and timely action to correct any dissatisfaction.&nbsp;</li><li>Organize and supervise the day-to-day operations of the relevant Food &amp; Beverage Outlet to ensure that all work within a specific team is carried out in an efficient manner and provide on-the-job training and constructive feedback to subordinates to support their overall development.&nbsp;</li><li>Ensure compliance with all relevant Health, Safety and Environment management procedures and controls within a defined area of activity so that Jumeirah group provides world class and luxurious hospitality services to its guests.</li><li>Implement approved departmental policies, processes and procedures, and provide instructions to subordinates and monitor their adherence so that work is carried out in a controlled and consistent manner while delivering a quality service to guests and maintaining standards of excellence.</li><li>Motivate subordinates and contribute to the identification of opportunities for participating in change initiatives, programs and projects considering best practices, improvement of processes and productivity improvement.</li></ul> Requirements: <ul><li>Work EXP: 1 Year</li><li>To assist the Food and Beverage Manager to plan</li><li>Organize and manage all processes of the outlet ensuring that the outlet provides quality food and beverage service</li><li>Achieves maximum revenue and profit in line with budgeted and forecasted projections.</li></ul>

Responsibilities: <ul><li>RBA Compliance &amp; Customer Expectations</li><li>Lead full implementation of RBA Code of Conduct to meet strict customer audit requirements.</li><li>Align site practices with both:</li><li>RBA standards</li><li>Malaysian labour regulations (Employment Act, Act 446, etc.)</li><li>Act as the primary interface with customers for all RBA/social compliance matters.</li></ul> Audit Management <ul><li>Own and manage:</li><li>RBA VAP audits</li><li>Customer social compliance audits</li><li>Prepare full audit readiness including:</li><li>Documentation (payroll, time records, policies)</li><li>Site walkthroughs and mock audits</li><li>Worker interview preparation</li><li>Drive fast turnaround of CAPA closures</li></ul> Foreign Worker &amp; Labour Compliance (Core Focus Area) <ul><li>Oversee compliance in:</li><li>Recruitment practices (agents, fees, contracts)</li><li>Passport handling and freedom of movement</li><li>Working hours &amp; overtime (strict monitoring required)</li><li>Ensure compliance with:</li><li>Zero forced labour expectations (high scrutiny from US/EU customers)</li><li>Partner with HR and hostel management on:</li><li>Worker onboarding &amp; orientation</li><li>Multilingual communication (BM, English, Bengali/Nepali/etc.)</li></ul> Dormitory &amp; Worker Welfare Management <ul><li>Ensure compliance with:</li><li>Act 446 (Workers’ Minimum Standards of Housing and Amenities)</li><li>RBA housing requirements</li><li>Conduct routine dorm inspections (cleanliness, density, safety).</li><li>Address welfare concerns quickly to prevent escalation into audit findings.</li></ul> Shopfloor Integration <ul><li>Work closely with production to ensure:</li><li>Overtime practices are controlled and compliant.</li><li>Line supervisors understand labour limits.</li><li>Conduct regular checks on attendance, OT, and operator conditions.</li><li>Ensure RBA practices are embedded in operations, not just documentation.</li></ul> EHS &amp; Chemical Compliance Alignment <ul><li>Collaborate with EHS on:</li><li>Chemical management (important in semiconductor/PCB environment)</li><li>PPE and safety compliance</li><li>Support alignment with:</li><li>ISO 14001 / ISO 45001 (common certifications in Penang plants)</li></ul> Supplier &amp; Subcon Compliance Support <ul><li>Support screening and monitoring of:</li><li>Local subcontractors, service providers, and labour suppliers</li><li>Ensure alignment with customer expectations on extended supply chain compliance.</li></ul> Training &amp; Awareness (Multicultural Workforce) <ul><li>Conduct practical, easy-to-understand training for:</li><li>Operators (often foreign workers)</li><li>Supervisors and line leaders</li><li>Use multilingual materials and real-life examples.</li></ul> Reporting &amp; Continuous Improvement <ul><li>Maintain audit documentation and compliance trackers.</li><li>Provide regular updates to management on: Risk areas, Audit readiness and Customer feedback</li><li>Drive continuous improvements to maintain competitiveness</li></ul> Requirements: <ul><li>Diploma / Degree in any field, or related field.</li><li>Minimum 7–10 years in: RBA / CSR / Social Compliance / HR Compliance / EHS</li><li>Strong preference for candidates with: Penang E&amp;E / semiconductor / EMS industry</li><li>Proven track record handling customer audits</li></ul>

Responsibilities: This position is responsible for mechanical maintenance and assembling automation systems in the manufacturing. <ul><li>Maintenance work on mechanical, electronic and pneumatic systems, including inspections, cleanings and lubrications.</li><li>Creation of machine safety concepts and machine data concepts.</li><li>Design and optimization of automation solutions for production plants using PLC controllers, robotics, industrial image processing, drive technology, testing technology, safety technology and other automation technologies.</li><li>Programming and commissioning of PLC controllers, safety controllers and HMI systems.</li><li>Mechanical design, assembly and wiring of machines and plants.</li><li>Integration of robotic systems and other automated components into existing production processes.</li><li>Functional tests and performance tests on automation systems, troubleshooting and optimization of control programs.</li><li>Preparation of technical documentation, operating instructions and training material.</li><li>Collaboration in planning and implementing projects for modernization and expansion of our production facilities.</li><li>Support in training of new employees in using new automation technologies.</li><li>Introduction of Industry 4.0 technologies (such as 3D printing, AMR, predictive maintenance, simulation, ).</li></ul> Requirements: <ul><li>Bachelors Degree in preferably mechanical engineering, automation engineering, mechatronics or a similar qualification.</li><li>Min 3 years of experience in industrial automation.</li><li>Knowledge of Cam-controlled machines like: Bihler (prefered), Wafios, Finzer.</li></ul>

Role Description: <ul><li>The Quality Associate I, Operations is responsible for actively participating in “on the floor” Quality activities during product manufacturing and/or packaging. Quality activities include product sampling and inspection, area clearance to confirm process readiness, non-conforming event support to resolve in-process issues, and process validation and qualification activities.</li><li>Communicates to multiple departments and supervision to provide timely process and issue updates.&nbsp;</li><li>Identifies and escalates issues or problems to appropriate supervision.</li><li>Participates as a team member on cross-functional teams. Participates in reviews and structured processes for continuous improvement</li></ul> Responsibilities: <ul><li>Performs physical inspection of in-process and finished product samples as assigned and according to the production schedule.</li><li>Collects samples from manufacturing and packaging according to the defined Batch Production Record and procedure requirements.</li><li>Is competent in all relevant processes (weighing, compounding, mixing, packaging, granulation, compression, coating, Liquids Mfg. and Batch Transfer, Creams &amp; Ointments Mfg. and Batch Transfer, Packaging, etc.) Follows internal processes related to controlled substances.</li><li>Performs GMP-related verifications including area, equipment and line clearances, cleaning, room inspection, material verification, etc. according to procedures</li><li>Actively participates in process validation and equipment qualification activities.</li><li>May execute computer data entries in SAP, Leucine, LIMS, and department databases.</li><li>Sampling and inspection of raw materials, packaging components, in-process, bulk, and finished drug product during manufacturing and packaging operations of commercial and non-commercial processes.</li><li>Performs manufacturing/packaging stage reviews of batch records.</li></ul> Requirements: <ul><li>High school diploma or equivalent with 4-7 years’ relevant experience OR</li><li>AA/AS degree with 3-6 years’ relevant experience OR</li><li>BA/BS degree with 2 -5 years’ relevant experienceRelated discipline and certification in assigned area a plus.</li><li>Experience with statistical sampling methods a plus.</li></ul> Knowledge &amp; Skills <ul><li>Attention to detail.</li><li>Strong documentation skills.</li><li>Ability to read and interpret SOPs and function within the scope of procedures.</li><li>Proficiency with basic math skills and basic experience with computers and software applications required.</li><li>Ability to learn new processes and procedures.</li><li>Able to communicate effectively with other departments, management and operational personnel.</li><li>Customer/Stakeholder focused (understands impact of daily work to compliance and overall business).</li><li>Proof-reading skills; ability to identify errors.</li><li>Ability to read and comprehend documentation and requirements set forth in Batch Production Records (BPRs).</li><li>Experience with Enterprise Resource Planning (ERP) system is a bonus.</li><li>Ability to work overtime as needed, including occasional weekend shifts.</li></ul> Physical Requirements <ul><li>Lift 15 lbs.</li><li>Walk across plant/warehouse.</li><li>Wear appropriate gowning as required.</li><li>Ability to read for extended periods of time.</li></ul>

Role Description: <ul><li>The Warehouse Technician will be responsible for executing material handling, inventory management, and warehouse operations in support of a sterile pharmaceutical manufacturing facility producing injectable IV bag products, including high potent APIs and controlled substances.</li><li>This role will ensure materials are received, stored, issued, and shipped in compliance with cGMP, DEA, and site safety requirements.</li><li>The Warehouse Technician will play a key role in maintaining accurate inventory records, supporting production schedules, and ensuring the cleanliness, organization, and security of the warehouse.</li></ul> Responsibilities: <ul><li>Receive, inspect, and verify incoming materials, components, and supplies against purchase orders and specifications.</li><li>Ensure proper storage of raw materials, packaging components, and controlled substances in compliance with cGMP, DEA, and safety requirements.</li><li>Accurately issue and deliver materials to production areas based on production schedules and work orders.</li><li>Operate warehouse equipment such as forklifts, pallet jacks, and material handling devices in a safe and compliant manner.</li><li>Perform cycle counts, physical inventory counts, and reconciliation of discrepancies in coordination with Inventory Control.</li><li>Maintain warehouse cleanliness, organization, and environmental conditions per site procedures and regulatory requirements.</li><li>Document all material transactions in the inventory management system, ensuring data accuracy and adherence to data integrity principles.</li><li>Prepare shipments of materials, components, or finished products in compliance with applicable regulations, including hazardous material handling requirements.</li><li>Support material sampling activities, including coordination with Quality Control for testing.</li><li>Assist in warehouse procedure creation, updates, and continuous improvement initiatives.</li><li>Ensure DEA security and access control measures are followed for controlled substances.</li><li>Collaborate with Production, Quality, Planning, and Procurement to ensure timely material availability for manufacturing operations.</li></ul> Requirements: Qualifications/Experience: <ul><li>High school diploma or equivalent required; Associate’s degree preferred.</li><li>Minimum of 2 years of warehouse or material handling experience in a cGMP-regulated pharmaceutical, biotechnology, or related manufacturing environment.</li><li>Experience handling controlled substances and/or high potent APIs preferred.</li><li>Knowledge of cGMP, DEA, and OSHA requirements for material handling and storage.</li><li>Experience operating forklifts and other warehouse equipment; forklift certification preferred.</li></ul> Skills/Competencies: <ul><li>Strong attention to detail and accuracy in documentation and inventory management.</li><li>Familiarity with inventory management systems and ERP software.</li><li>Ability to work effectively in a fast-paced, highly regulated environment.</li><li>Strong organizational skills with the ability to prioritize tasks.</li><li>Good communication and teamwork skills.</li><li>Commitment to safety, compliance, and maintaining a secure warehouse environment.</li><li>Ability to lift and move materials in accordance with safety guidelines.</li></ul>

Job Summary: <ul><li>This position is dedicated to the review, verification, and assessment of analytical data generated within the Quality Control laboratory.&nbsp;</li><li>The role ensures that all laboratory documentation meets cGMP, regulatory, and internal quality standards.&nbsp;</li><li>Responsibilities do not include performing laboratory testing, operating instruments, or releasing materials or products.</li></ul> Responsiblities: <ul><li>Review complete analytical data packages generated from a wide range of QC laboratory instrumentation, including HPLC, UPLC, GC, UV?Vis, FT?IR, Dissolution, X?Ray Diffraction (XRD), pH meters, Karl Fischer, ICP-MS, and other compendial or platform - specific systems.</li><li>Verify calculations, chromatographic integrations, peak assignments, system suitability criteria, and instrument audit trails across software platforms such as Empower, ChemStation, LabSolutions, ICP?MS data systems, and dissolution software.</li><li>Assess data for compliance with approved analytical methods, compendial requirements, SOPs, and cGMP expectations, ensuring consistency across diverse analytical techniques.</li><li>Evaluate raw data outputs such as chromatograms, spectra (UV, IR), dissolution profiles, XRD patterns, elemental analysis reports, pH logs, and mass spectrometry data for accuracy and scientific soundness.</li><li>Identify discrepancies, atypical trends, integration anomalies, missing data, or potential data integrity concerns and escalate findings promptly.</li><li>Confirm that all raw data, worksheets, logbooks, electronic records, and metadata comply with ALCOA+ principles and meet internal documentation standards.</li><li>Review LIMS entries for accuracy, completeness, and proper linkage to supporting raw data and metadata.</li><li>Ensure instrument-specific parameters (e.g., wavelength accuracy for UV, calibration curves for ICP?MS, dissolution run conditions, GC column performance) are appropriately documented and meet acceptance criteria.</li></ul> Requirements: Education &amp; Experience: <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>Bachelor of Science Degree in chemistry, chemical engineering or related field with 4+ years’ relevant analytical laboratory experience OR</li><li>Master’s Degree in above disciplines with 2+ years’ relevant analytical lab experience</li></ul> Knowledge: <ul><li>Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations and custom reports</li><li>Full proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.</li><li>Thorough knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS</li><li>Has demonstrated competence in conducting chemical analyses</li><li>Strong knowledge of wet chemistry techniques</li><li>Competency in Microsoft Office Suite</li></ul> Skills &amp; Abilities: <ul><li>Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information, reporting to management</li><li>Ability to display and analyze data in a logical manner</li><li>Ability to critically review, analyze data, interpret information, and draw conclusions from relevant or missing information</li><li>Ability to display and analyze data in a logical manner</li><li>Strong verbal and written communication skills as well as good computer skills</li><li>Strong 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 coach less senior staff and develop laboratory skills and ability</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.&nbsp;</li><li>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: QMS Ownership for Deliverable Software <ul><li>Translate AS9115 Rev A and AS9100:2016 requirements into practical procedures, work instructions, and templates.</li><li>Establish processes covering software planning, development, integration, verification/validation, release, delivery, and post-delivery support.</li><li>Ensure the QMS supports multiple development models (Agile, Waterfall, Incremental) while enforcing required quality controls including reviews, approvals, traceability, and documentation.</li></ul> Software Planning &amp; Requirements Quality <ul><li>Lead the creation and maintenance of Software Quality Plans.</li><li>Establish standards for requirements management ensuring requirements are:</li></ul> <ul><li>Clear</li><li>Unambiguous</li><li>Testable</li><li>Maintain bidirectional traceability from:</li><li>Requirements → Design → Code → Test → Release.</li></ul> Configuration Management &amp; Change Control Define standards for Software Configuration Management (CM) including: <ul><li>Baselines</li><li>Configuration item identification</li><li>Change evaluation and approval</li><li>Configuration status accounting</li><li>Integrate software configuration management with product and system configuration processes.</li><li>Ensure CM covers software, documentation, tools, environments, and build/release artifacts.</li></ul> Supplier &amp; COTS/NDS Management <ul><li>Establish standards for evaluation and acceptance of Commercial Off-The-Shelf (COTS) and Non-Developmental Software (NDS) used in deliverable products.</li><li>Define AS9115 control applicability with both customers and suppliers.</li><li>Support supplier qualification, audits, and incoming verification for software deliverables and services.</li></ul> Verification, Validation &amp; Test Assurance <ul><li>Define verification standards within the QMS including:</li><li>Static analysis</li><li>Peer reviews</li><li>Unit testing</li><li>Integration testing</li><li>System testing</li><li>Regression testing</li><li>Security testing</li><li>Ensure independence of verification activities where required.</li><li>Maintain controlled test environments, data integrity, and objective evidence for compliance audits.</li></ul> Release, Delivery &amp; Post-Delivery Support Develop procedures for: <ul><li>Software release criteria</li><li>Delivery records</li><li>Installation documentation</li><li>Post-delivery issue management</li><li>Patching and configuration updates</li><li>Ensure all processes align with AS9115 standards.</li></ul> Audits, Metrics &amp; Continuous Improvement Lead internal and customer audits related to AS9115/AS9100 compliance. <ul><li>Manage Corrective and Preventive Actions (CAPA).</li><li>Support external and second-party audits with aerospace OEMs.</li><li>Define and track key quality KPIs, including:</li><li>Requirements volatility</li><li>Defect density</li><li>Defect escape rate</li><li>Verification coverage</li><li>Audit findings aging</li><li>Build reproducibility</li><li>Change lead time</li></ul> Requirements: Bachelor’s or Master’s degree in: <ul><li>Software Engineering</li><li>Computer Science</li><li>Systems Engineering or a related discipline.</li><li>Minimum 5 years of experience in software quality or software engineering within aerospace, defense, or other regulated industries.</li><li>Hands-on experience implementing AS9100 quality processes with working knowledge of AS9115 software lifecycle controls.</li></ul> Strong experience in: <ul><li>Requirements management</li><li>Configuration management</li><li>Verification and validation</li><li>Software release governance</li><li>Experience managing COTS/NDS software integration and supplier quality.</li><li>Proven ability to lead audit activities and corrective actions using structured problem-solving tools such as:</li><li>5 Why</li><li>Ishikawa</li><li>8D</li></ul> Preferred Qualifications <ul><li>Experience supporting AS9115 second-party audits with aerospace OEMs.</li><li>Familiarity with DO-178C concepts and coordination with DO-254/ED-80 hardware processes.</li><li>Experience with ALM/PLM and configuration management tools, such as:</li><li>Polarion</li><li>IBM DOORS</li><li>CodeBeamer</li><li>Git / GitLab</li><li>Bitbucket</li><li>Azure DevOps</li><li>Knowledge of CI/CD pipelines, static analysis tools, and unit testing frameworks.</li><li>Exposure to CMMI-DEV processes and experience aligning them with AS9115 quality objectives.</li></ul>

Role Description:&nbsp; <ul><li>To lead and manage Electrical, Electronics, PLC, and Mechanical maintenance activities across processing and packing assets.&nbsp;</li><li>The role is responsible for ensuring safe, reliable, and efficient operation of equipment by eliminating electrical, automation, mechanical, and process-related. breakdowns, improving equipment reliability and OEE, and strategically reducing unplanned downtime through effective maintenance execution and team leadership.&nbsp;</li></ul> Responsibilities: <ul><li>Lead, coordinate, and manage both Electrical and Mechanical Maintenance teams.&nbsp;</li><li>Provide hands-on technical leadership for electrical, electronics, PLC, and mechanical breakdowns.&nbsp;</li><li>Manage preventive, corrective, and condition-based maintenance activities across all processing and packing equipment.&nbsp;</li><li>Troubleshoot PLC-controlled systems including fault diagnostics, I/O checks, sensors, actuators, and basic logic analysis.&nbsp;</li><li>Oversee mechanical maintenance activities including rotating equipment, conveyors, gearboxes, bearings, and drive systems.&nbsp;</li><li>Guide maintenance teams in root cause analysis (RCA), loss analysis, and implementation of permanent corrective actions.&nbsp;</li><li>Ensure effective maintenance planning, execution, and reporting through SAP PM.&nbsp;</li><li>Own and maintain electrical, automation, and mechanical spare parts inventories, ensuring availability of critical spares.&nbsp;</li><li>Develop maintenance standards, work instructions, and OPLs for electrical, PLC, and mechanical activities.&nbsp;</li><li>Support technician capability development through coaching and technical training (electrical, PLC, and mechanical).&nbsp;</li><li>Ensure compliance with EHS, QFS, and machinery safety standards during all maintenance activities.&nbsp;</li><li>Maintain accurate documentation and records to support internal and external audits (EHS, QFS, KWS, FSSC, etc.).&nbsp;</li></ul> Key Performance Indicators (KPIs):&nbsp; <ul><li>Reduction of unplanned downtime.&nbsp;</li><li>Improvement of equipment reliability and OEE.&nbsp;</li><li>Preventive maintenance on-time completion rate.</li><li>Breakdown response time and MTTR.&nbsp;</li><li>Maintenance cost control and spare parts availability.&nbsp;</li><li>Electrical and Mechanical team capability development.&nbsp;</li></ul> Requirements: <ul><li>Bachelor’s degree in Electrical &amp; Electronics Engineering or Mechatronics Engineering.&nbsp;</li><li>Minimum 5 years of maintenance experience in manufacturing or FMCG environments.&nbsp;</li><li>Proven experience in leading both electrical and mechanical maintenance teams.&nbsp;</li><li>Strong knowledge of industrial electrical, electronic, automation, and mechanical systems.&nbsp;</li><li>Mandatory PLC knowledge : - Fault finding and diagnostics - I/O modules, field devices, and communication basics - Ability to read and analyze PLC logic&nbsp;</li><li>Solid mechanical knowledge including rotating equipment, gearboxes, bearings, conveyors, and power&nbsp;transmission systems.&nbsp;</li><li>Experience with motors, inverters, servo drives, sensors, actuators, and control systems.&nbsp;</li><li>Experience with SAP PM or similar CMMS systems.&nbsp;</li><li>Strong leadership, problem-solving, communication, and decision-making skills.</li></ul>

Responsibilities: <ul><li>Operate, monitor, and adjust sterile manufacturing equipment used for formulation, filling, and packaging of IV bag products in compliance with cGMP and SOPs.</li><li>Perform routine preventive maintenance on production equipment to ensure operational readiness and minimize downtime.</li><li>Support equipment and process qualifications, including execution assistance, documentation support, and adherence to qualification protocols.</li><li>Act as first-line troubleshooting support for mechanical or operational equipment issues, escalating to Engineering or Maintenance as required.</li><li>Assist with isolator technology operations, including cleaning, sterilization, and environmental control procedures.</li><li>Participate in line clearance, changeover, and cleaning activities to maintain continuous production operations.</li><li>Accurately complete batch records, logbooks, and production documentation in compliance with data integrity and cGMP requirements.</li><li>Collaborate with Quality Assurance during in-process checks, deviation investigations, and CAPA activities.</li><li>Adhere to DEA and site procedures for controlled substance handling, including documentation and security protocols.</li><li>Contribute to continuous improvement initiatives focused on safety, efficiency, and product quality.</li><li>Work closely with cross-functional teams, including Engineering, Validation, and Quality, to support operational readiness.</li><li>Comply with all Environmental Health &amp; Safety (EHS) standards and maintain a clean and safe work environment.</li></ul> Key Stakeholders Internal <ul><li>Production Supervisor and Production Manager</li><li>Engineering and Maintenance</li><li>Validation and Quality Assurance</li><li>Materials and Warehouse Teams</li><li>Environmental Health &amp; Safety (EHS)</li></ul> External <ul><li>Equipment vendors and service technicians (as required)</li></ul> Requirements: Qualifications &amp; Experience <ul><li>High school diploma or equivalent required; Associate degree or technical certification in mechanical, engineering, or life sciences preferred.</li><li>Minimum 2 years of experience in pharmaceutical or other regulated manufacturing environments, including compounding, filling, inspection, or secondary packaging.</li><li>Prior experience with sterile products or IV bag manufacturing strongly preferred.</li><li>Strong mechanical aptitude with the ability to perform routine maintenance and troubleshoot equipment issues.</li><li>Experience operating automated production equipment using HMI or SCADA interfaces required.</li><li>Working knowledge of cGMP, aseptic processing, and controlled substance regulations preferred.</li><li>Ability to read, understand, and follow SOPs, maintenance procedures, and qualification protocols.</li></ul> Skills &amp; Competencies <ul><li>Strong technical and mechanical problem-solving skills</li><li>High attention to detail with a commitment to quality and data integrity</li><li>Ability to work effectively in a fast-paced, highly regulated environment</li><li>Strong verbal and written communication skills</li><li>Team-oriented mindset with a collaborative approach</li><li>Comfortable working in cleanroom environments with PPE requirements</li></ul>

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12 dea controlled substances Jobs found

SUPV I (Supervisor-I) – Maintenance, Grade 5-4

Outlet Manager

HR Partner IV - RBA Lead

Mechanical Maintenance Engineer - Automation Technology

QA Associate II

Warehouse Technician

Chemist Data Reviewer

Staff Advanced Quality Engineer (Software)

Maintenance Engineer

Production Technician I

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12 dea controlled substances Jobs found

SUPV I (Supervisor-I) – Maintenance, Grade 5-4

Outlet Manager

HR Partner IV - RBA Lead

Mechanical Maintenance Engineer - Automation Technology

QA Associate II

Warehouse Technician

Chemist Data Reviewer

Staff Advanced Quality Engineer (Software)

Maintenance Engineer

Production Technician I

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WhiteCrow is on a mission to connect companies with the best talent across the globe.