Manager - Environmental Health & Safety (EHS)

QE Specialist

Environmental Health and Safety (EHS) Manager

Quality Engineer

Process Mechanic – Sterile Filling & Packaging

Facility Mechanic

Technical Support Manager

Responsibilities: Planning and Budgeting&nbsp;<ul><li>Initiate and execute annual EHS &amp; S improvement project plan, EHS &amp; S training plan, EHS &amp; S internal audit plan and annual EHS &amp; S budget&nbsp;</li></ul> People Management &amp; Development&nbsp;&nbsp; <ul><li>Allocate and balance work across direct reports, review and provide timely performance feedback to subordinate, coach, guide, develop and motivate them,&nbsp;</li><li>help to resolve functional issues in the team, submit manpower request and interview candidates in order to achieve targeted function performance goal.&nbsp;</li><li>Develop skills of direct reports and others with EHS &amp; S responsibilities in the organization.&nbsp;</li></ul> EHS Structure &amp; Program Management&nbsp; <ul><li>Build action plans for the implementation of the organization’s EHS &amp; S programs and take a leadership role in execution in order to deliver the organization’s EHS &amp; S goals and strategy.&nbsp;</li><li>Setting up strong Safety First culture.&nbsp;</li><li>Establish and develop procedures and teams for driving EHS improvements and managing EHS programs.&nbsp;</li><li>Communicate with all levels in the organization on EHS to engage with, influence and promote EHS culture.&nbsp;&nbsp;</li><li>Follow up internal and external audit to verify EHS performance and continue improvement&nbsp;</li><li>Maintein ISO14001 and our client compliance tools.&nbsp;</li><li>Ensure safety of construction projects in the Thailand Erni site.&nbsp;</li><li>Ensure safety of plant moving, including but not limited to moving IND equipment out and DDN equipment in. As well as its installation and&nbsp;</li><li>commissioning safety&nbsp;</li></ul> Reporting&nbsp; Implement below tasks in order to meet the requirements of reporting.&nbsp; <ul><li>Report related required EHS&amp;S data to site, BU management, BU EHS and Corporate EHS.&nbsp;</li><li>Report related EHS&amp;S data required based on applicable legal regulations and company policies.&nbsp;</li><li>Monitor and report organizational safety performance against our client Safety Tool.&nbsp;</li><li>Evaluate and report environmental performance quarterly using company environmental assessment tools.&nbsp;</li></ul> Sustainability and BCP&nbsp; Focus on GHG, energy,&nbsp;hazardous waste &amp; scope 3 reduction.&nbsp;&nbsp; <ul><li>Track energy reducion data.&nbsp;</li><li>Work with Facility team to identify opportunities of energy reduction.&nbsp;</li><li>Coordinate business contunity plan of DG site.&nbsp;</li><li>Follow BU, Seg and Corp policy and lead scope 3 reduction of the site&nbsp;</li></ul> Requirements: <ul><li>University degree or equivalent level of qualification in safety, health, environmental, chemical, mechanical or related technical discipline&nbsp;</li><li>Thailand government required qualification as company EHS manager is a MUST&nbsp;</li><li>Professional EHS Certification preferred.&nbsp;</li><li>Minimum 8+ years EHS experience required.&nbsp;</li><li>Minimum 5+ years experience in EHS management in manufacturing.&nbsp;</li><li>3+ years construction safety experience is a MUST.&nbsp;</li><li>Knowledge and experenice on scope 3 is preferred.</li></ul>

Responsibilities: <ul><li>Provide real-time QA oversight on the production floor, in warehouse areas, and during qualification activities.</li><li>Perform batch record and logbook review, ensuring accuracy, completeness, and compliance with GDP standards.</li><li>Execute and document line clearance and room readiness inspections prior to manufacturing activities.</li><li>Review qualification and validation protocols for clarity, compliance, and alignment with regulatory and internal quality expectations.</li><li>Support execution of qualification protocols by providing on-site quality presence during testing and ensuring deviations are properly documented and escalated. 6.	Initiate, investigate, and support closure of deviations, non-conformances, and CAPAs related to manufacturing and qualification activities.</li><li>Collaborate with cross-functional teams to ensure timely and compliant execution of commissioning, qualification, and validation activities.</li><li>Support the development and maintenance of site-specific quality procedures (SOPs, work instructions, forms) governing manufacturing, warehousing, engineering, maintenance, and validation operations.</li><li>Review and approve site procedures to ensure clarity and compliance with cGMP standards.</li><li>Maintain awareness of site policies, cGMP regulations, and evolving regulatory expectations applicable to sterile injectable operations.</li><li>Participate in internal walkthroughs, audit preparations, and readiness activities for regulatory inspections.</li><li>Support the implementation of continuous improvement initiatives and site quality metrics.</li></ul> Requirements: Qualifications/Experience <ul><li>Bachelor’s degree in a scientific, engineering, or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering)</li><li>2–5 years of experience in quality assurance, manufacturing, or validation in a cGMP-regulated pharmaceutical or biotech manufacturing environment</li><li>Working knowledge of FDA, EU, and ICH guidelines related to sterile manufacturing, validation, and data integrity</li><li>Experience supporting commissioning and qualification activities is strongly preferred</li><li>Familiarity with GDP, batch record review, and deviation documentation processes</li></ul> Skills/Competencies <ul><li>Strong attention to detail and commitment to compliance</li><li>Solid written and verbal communication skills</li><li>Ability to work collaboratively across departments in a fast-paced environment</li><li>Comfortable supporting shop-floor activities and cross-functional execution teams</li><li>Proficient in using quality systems and document management tools</li><li>Flexible and adaptable to changing priorities and evolving project timelines</li><li>Commitment to data integrity, continuous improvement, and patient safety</li></ul>

Responsibilites: <ul><li>Develop and implement site-wide EHS programs aligned with federal, state, and local regulations, including OSHA, EPA, and DEA requirements for controlled substances.</li><li>Lead risk assessments, job hazard analyses (JHAs), and containment evaluations, particularly in areas handling high-potent and controlled substances.</li><li>Serve as the primary liaison for EHS-related aspects of DEA compliance, supporting controlled substance handling protocols in collaboration with Quality, Security, and Operations.</li><li>Oversee the environmental and safety controls for controlled substances, ensuring proper ventilation, storage, access restrictions, spill response, and waste disposal procedures in compliance with DEA and EPA regulations.</li><li>Develop and maintain physical and procedural controls related to controlled substance areas (e.g., vaults, restricted labs, destruction processes) in partnership with Security and Regulatory Affairs.</li><li>Lead the investigation and root cause analysis of all incidents, near-misses, and controlled substance discrepancies, and implement corrective/preventive actions.</li><li>Ensure training and education of site personnel in EHS best practices, with a focus on potent compound safety, exposure monitoring, and controlled substance handling protocols.</li><li>Implement industrial hygiene programs, including monitoring of airborne concentrations and potential operator exposure to potent and hazardous compounds.</li><li>Establish robust programs for emergency preparedness, including chemical spills, fires, security threats, and controlled substance incidents.</li><li>Maintain all required permits, records, and documentation related to hazardous waste, emissions, safety incidents, and controlled substance EHS compliance.</li><li>Partner with Engineering, Validation, and Operations to incorporate EHS and security standards into facility, utility, and equipment design and commissioning.</li><li>Foster a strong culture of safety, accountability, and environmental stewardship at all levels of the organization.</li></ul> Requirements: <ul><li>Bachelor’s degree in Environmental Science, Occupational Health &amp; Safety, Chemical Engineering, or related field (Master’s preferred).</li><li>Minimum of 7–10 years of progressive EHS experience in a GMP-regulated pharmaceutical or biotechnology manufacturing environment.</li><li>Direct experience managing EHS compliance for controlled substances (DEA Schedules II–V) and high-potency APIs strongly preferred.</li><li>In-depth knowledge of OSHA, EPA, DEA, NJDEP, and global EHS regulations and guidelines.</li><li>Familiarity with industrial hygiene, containment technologies, and safe handling procedures for potent compounds</li><li>Experience leading EHS activities during greenfield/startup site development and qualification is a plus.</li></ul>

Responsibilities: <ul><li>Act as technical expert and provide QA support during facility, utility, manufacturing equipment, and laboratory instrument qualification by reviewing qualification and validation protocols for clarity, compliance, and alignment with regulatory and internal quality expectations. Collaborate with cross-functional teams to ensure timely and compliant execution of commissioning, qualification, and validation activities</li><li>Review and approve qualification protocols and final reports (equipment, utilities, facilities, processes) to ensure alignment with quality and regulatory standards.</li><li>Support execution of qualification protocols by providing on-site quality presence during testing and ensuring deviations are properly documented and escalated</li><li>Provide QA support during technical transfer and process validation of new products.</li><li>Provide support to operation during Change Control and Deviation process. Drive timely and compliant resolution of deviations, non-conformances, and CAPAs arising during operations and qualification activities. </li><li>Support the development and maintenance of site-specific quality procedures (SOPs, work instructions, forms) governing manufacturing, warehousing, engineering, maintenance, and validation operations.</li><li>Maintain awareness of site policies, cGMP regulations, and evolving regulatory expectations applicable to sterile injectable operations.</li><li>Provide QA support during regulatory inspection. Participate in internal walkthroughs and audit. &nbsp;</li><li>Prepare quality and compliance metrics to support continuous improvements</li></ul> Requirements: Qualifications/Experience <ul><li>Bachelor’s degree in a scientific, engineering, or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering)</li><li>Minimum of 7-10 years of experience in quality assurance, manufacturing, or validation in a cGMP-regulated pharmaceutical or biotech manufacturing environment</li><li>Working knowledge of FDA, EU, and ICH guidelines related to sterile manufacturing, validation, and data integrity</li><li>Experience supporting commissioning and qualification activities </li><li>Ability to work collaboratively with operations, engineering, and validation stakeholders</li></ul> Skills/Competencies <ul><li>Strong attention to detail and commitment to compliance</li><li>Solid written and verbal communication skills</li><li>Ability to work collaboratively across departments in a fast-paced environment</li><li>&nbsp;Strong knowledge of validation principles and qualification documentation </li><li>Proficient in using quality systems and document management tools</li><li>Flexible and adaptable to changing priorities and evolving project timelines</li><li>Commitment to data integrity, continuous improvement, and patient safety</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>

Overview: <ul><li>The Technical Support Manager 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 injectable manufacturing site.&nbsp;</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.&nbsp;</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. During the start up phase this role will include the development of an asset management system and the development of standard operating procedures for the maintenance and calibration of systems across the plant.</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 the development of standard operating procedures as required.&nbsp;&nbsp;</li><li>Champion the start up and maintenance of an asset management system that will become the basis of technical support in the plant.&nbsp;&nbsp;</li><li>Lead daily planning, prioritization, and execution of maintenance and reliability activities.&nbsp;</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 and asset management 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.&nbsp;</li></ul> Key Stakeholders: Internal: <ul><li>Site Leadership Team (Operations, Quality, Engineering, Warehouse, HR, Finance, EHS)</li><li>Manufacturing Teams</li><li>Validation and Project Management Teams</li></ul> External: <ul><li>FDA and other regulatory agencies</li><li>Third-party auditors and certifying bodies</li><li>External service providers such as calibration and maintenance service companies</li><li>Customers and business partners</li></ul> Requirements: Qualifications / Experience: <ul><li>Bachelor’s degree in engineering is required. Degree in Mechanical, Electrical, Biomedical, or similar preferred.</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 working with a qualified asset management system.&nbsp;(Current system is SAP PM)</li><li>Experience in controlled substance and high potent product environment desired but not required.</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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7 commissioning Jobs found

Manager - Environmental Health & Safety (EHS)

QE Specialist

Environmental Health and Safety (EHS) Manager

Quality Engineer

Process Mechanic – Sterile Filling & Packaging

Facility Mechanic

Technical Support Manager

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7 commissioning Jobs found

Manager - Environmental Health & Safety (EHS)

QE Specialist

Environmental Health and Safety (EHS) Manager

Quality Engineer

Process Mechanic – Sterile Filling & Packaging

Facility Mechanic

Technical Support Manager

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

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