Production Technician I

Compounding Technician

Filling Technician

Junior Graphic Designer (Contractual)

Production Supervisor

Manager, Site Logistics & Project Integration

Process Technologist Manager (GL3)

Process Mechanic – Sterile Filling & Packaging

Technical Support Manager

Manager, Operations

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>

Responsibilities: <ul><li>Operate, monitor, and adjust sterile manufacturing equipment for formulation, filling, and packaging of IV bag products in compliance with SOPs, cGMP, and safety requirements.</li><li>Perform routine preventive maintenance and minor repairs on production equipment to maintain optimal operating conditions.</li><li>Serve as first-line troubleshooting support for equipment and process issues, escalating to engineering or maintenance as required.</li><li>Support equipment and process qualifications, including protocol review, execution participation, and documentation completion.</li><li>Assist in the creation, revision, and implementation of SOPs and production-related procedures.</li><li>Provide training, guidance, and on-the-job support to Production Technician I personnel.</li><li>Perform cleaning, changeover, and line clearance activities to maintain manufacturing operations.</li><li>Accurately complete batch records, logbooks, and production documentation in compliance with data integrity requirements and cGMP practices.</li><li>Review documentation completed by fellow members of the production team.</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>Work closely with cross-functional teams including Engineering, Validation, and Quality to support operational readiness.</li><li>Operate isolator technology, including performing and verifying sanitization steps, and supporting advanced troubleshooting.</li><li>Ensure controlled substances are handled, documented, and stored per DEA and site requirements.</li><li>Participate in continuous improvement and lean manufacturing initiatives to enhance safety, quality, and efficiency.</li></ul> Requirements: Qualifications / Experience <ul><li>High school diploma or equivalent required; associate degree or technical certification in a mechanical, engineering, or life sciences discipline preferred.</li><li>Minimum of 5 years’ experience in pharmaceutical or regulated manufacturing in areas of compounding, filling, inspection, and secondary packaging. Experience with sterile products or IV bag production preferred.</li><li>Demonstrated mechanical aptitude with hands-on equipment troubleshooting and maintenance skills.</li><li>Knowledge of cGMP, aseptic processing, and controlled substance handling requirements.</li><li>Minimum of 3 years’ experience working with automated production equipment utilizing HMI or SCADA interface required.</li><li>Experience with isolator-based manufacturing strongly preferred.</li><li>Experience reading and following technical documents such as SOPs, maintenance procedures, electrical drawings, equipment arrangements, piping diagrams, and qualification protocols</li></ul> Skills / Competencies <ul><li>Demonstrated problem-solving and mechanical troubleshooting skills.</li><li>Ability to mentor and train less experienced technicians.</li><li>Excellent attention to detail and documentation accuracy.</li><li>Effective communication and teamwork skills.</li><li>Commitment to safety, quality, and data integrity.</li><li>At home working in cleanroom environments with PPE requirements.</li></ul>

Responsibilities: <ul><li>Operate, monitor, and adjust sterile manufacturing equipment for formulation, filling, and packaging of IV bag products in compliance with SOPs, cGMP, and safety requirements.</li><li>Perform routine preventive maintenance and minor repairs on production equipment to maintain optimal operating conditions.</li><li>Serve as first-line troubleshooting support for equipment and process issues, escalating to engineering or maintenance as required.</li><li>Support equipment and process qualifications, including protocol review, execution participation, and documentation completion.</li><li>Assist in the creation, revision, and implementation of SOPs and production-related procedures.</li><li>Provide training, guidance, and on-the-job support to Production Technician I personnel.</li><li>Perform cleaning, changeover, and line clearance activities to maintain manufacturing operations.</li><li>Accurately complete batch records, logbooks, and production documentation in compliance with data integrity requirements and cGMP practices.</li><li>Review documentation completed by fellow members of the production team.</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>Work closely with cross-functional teams including Engineering, Validation, and Quality to support operational readiness.</li><li>Operate isolator technology, including performing and verifying sanitization steps, and supporting advanced troubleshooting.</li><li>Ensure controlled substances are handled, documented, and stored per DEA and site requirements.</li><li>Participate in continuous improvement and lean manufacturing initiatives to enhance safety, quality, and efficiency.</li></ul> Requirements: Qualifications / Experience&nbsp; <ul><li>High school diploma or equivalent required; associate degree or technical certification in a mechanical, engineering, or life sciences discipline preferred.</li><li>Minimum of 5 years’ experience in pharmaceutical or regulated manufacturing in areas of compounding, filling, inspection, and secondary packaging. Experience with sterile products or IV bag production preferred.</li><li>Demonstrated mechanical aptitude with hands-on equipment troubleshooting and maintenance skills.</li><li>Knowledge of cGMP, aseptic processing, and controlled substance handling requirements.</li><li>Minimum of 3 years’ experience working with automated production equipment utilizing HMI or SCADA interface required.</li><li>Experience with isolator-based manufacturing strongly preferred.</li><li>Experience reading and following technical documents such as SOPs, maintenance procedures, electrical drawings, equipment arrangements, piping diagrams, and qualification protocols</li></ul> Skills/Competencies <ul><li>Demonstrated problem-solving and mechanical troubleshooting skills.</li><li>Ability to mentor and train less experienced technicians.</li><li>Excellent attention to detail and documentation accuracy.</li><li>Effective communication and teamwork skills.</li><li>Commitment to safety, quality, and data integrity.</li><li>At home working in cleanroom environments with PPE requirements.</li></ul>

This is 1 year Contractual role. Responsibilities: <ul><li>Support the Marketing team in developing design for both online and offline channels, including social media content, banners, POSM, key visuals and other marketing materials.</li><li>Handle regulatory-related artwork tasks such as product label adjustments, packaging updated and compliance revisions.</li><li>Develop creative concepts and produce high-quality artwork that align with brand identity and campaign objectives.</li><li>Collaborate and communicate with regional teams to align on briefs, feedback and deliver final artwork to meet expectations.</li><li>Work with external agencies by ensuring all deliverables align with brand guidelines.</li><li>Adapt, resize master assets for various markets, formats and platforms as required.</li><li>Create realistic products and packaging mockups to support presentations and marketing materials.</li><li>Ensure all artwork is delivered on time while maintaining high levels of accuracy, consistency and attention to details.</li><li>Support ad hoc design requests and collaborate with cross-functional teams when needed.</li></ul> Requirements: <ul><li>Education Background: Communication/Design/Creative</li><li>Education Level: Bachelor’s Degree</li><li>Working Experience: Min 2-3 years of working experiences in related area</li><li>Experience on brand design and copywriting , Adobe creative suite (Adobe illustrator &amp; Adobe Photoshop), 3D mock-up, Adobe premiere pro/adobe after affects will be a plus</li></ul>

Responsibilities: <ul><li>Supervise daily manufacturing operations including formulation, filling, and packaging of sterile injectable IV bag products within cleanroom environments utilizing isolator technology.</li><li>Manage and develop production team members, providing coaching, training, and performance feedback to ensure adherence to standard operating procedures (SOPs) and quality expectations.</li><li>Author, review, and approve SOPs, batch records, and other production documentation to ensure compliance with cGMP and regulatory requirements.</li><li>Ensure compliance with cGMP, FDA, DEA, OSHA, and other regulatory requirements, particularly in handling high potent APIs and controlled substances.</li><li>Coordinate production schedules to meet demand and support planning, warehouse, and materials management functions.</li><li>Monitor key performance indicators (KPIs) for productivity, quality, and safety; implement corrective and preventive actions as needed.</li><li>Oversee line clearance, equipment setup, and cleaning activities, ensuring readiness for manufacturing operations and minimizing downtime.</li><li>Support deviations, investigations, and CAPA implementation in partnership with Quality Assurance and other support functions.</li><li>Drive continuous improvement initiatives to enhance operational efficiency, product quality, and operator engagement.</li><li>Ensure effective communication between production shifts and other departments to maintain smooth and efficient operations.</li><li>Maintain a strong safety culture, ensuring compliance with Environmental Health &amp; Safety (EHS) programs and best practices.</li></ul> Requirements: Qualifications/Experience: <ul><li>Bachelor’s degree in engineering, Life Sciences, or a related technical field preferred; equivalent experience considered.</li><li>Minimum of 3–5 years’ experience in pharmaceutical or biotechnology manufacturing, preferably in sterile or aseptic operations.</li><li>Supervisory experience leading production teams in a regulated environment.</li><li>Knowledge of cGMP, aseptic processing, and isolator-based manufacturing.</li><li>Experience with high potent APIs and/or controlled substances preferred.</li><li>Proficiency with production documentation, batch records, SOP authoring, and deviation processes.</li></ul> Requirements: Skills / Competencies: <ul><li>Strong leadership and team management skills with a focus on employee development.</li><li>Excellent organizational and problem-solving abilities.</li><li>Ability to manage multiple priorities in a fast-paced, dynamic environment.</li><li>Clear, concise communication skills (written and verbal).</li><li>Proficiency in Microsoft Office and familiarity with manufacturing execution systems (MES) or ERP platforms.</li><li>Commitment to data integrity, safety, and continuous improvement.</li></ul>

Responsibilities: Warehouse &amp; Materials Management <ul><li>Oversee all warehouse activities including receiving, storage, handling, and internal material movement to ensure compliance with cGMP, DEA, and safety regulations.</li><li>Develop and maintain systems for inventory management, accuracy, and traceability, including raw materials, components, packaging, and finished goods.</li><li>Ensure timely and compliant movement of materials to support production schedules and product release timelines.</li><li>Collaborate with Quality and Compliance teams to maintain cGMP storage practices, support inspections, and ensure readiness.</li></ul> Planning &amp; Supply Coordination <ul><li>Lead the site’s production and materials planning processes to ensure timely availability of materials and resources to meet manufacturing demands.</li><li>Manage and optimize the site’s Master Production Schedule (MPS), material requirement planning (MRP), and capacity planning tools.</li><li>Coordinate with corporate Supply Chain and Procurement functions to align site planning with supplier performance and external manufacturing dependencies.</li></ul> Project Management &amp; Integration <ul><li>Serve as a site-level project manager for cross-functional initiatives including new product introductions (NPIs), facility readiness, equipment onboarding, and continuous improvement projects.</li><li>Develop project timelines, resource allocations, risk assessments, and stakeholder communication plans to ensure successful project execution.</li><li>Support greenfield and expansion activities by coordinating logistics, materials, and equipment staging activities.</li></ul> Systems &amp; Process Development <ul><li>Lead implementation and optimization of ERP and warehouse management systems to enable efficient and compliant operations.</li><li>Develop and implement SOPs, training programs, and KPIs across warehouse and planning functions.</li><li>Identify opportunities for process automation, waste reduction, and continuous improvement in site logistics operations.</li></ul> Requirements: Qualifications / Experience: <ul><li>Bachelor’s degree in Supply Chain, Engineering, Business, Operations Management, or related field.</li><li>7+ years of progressive experience in warehouse, planning, or project management roles within pharmaceutical or highly regulated industries.</li><li>Strong understanding of cGMPs, DEA requirements for controlled substances, and sterile manufacturing logistics.</li><li>Proven experience implementing ERP systems (SAP, Oracle, etc.) and managing warehouse or supply chain digital tools.</li><li>PMP certification or formal project management training strongly preferred.</li></ul> Skills/Competencies: <ul><li>Strong organizational, analytical, and problem-solving skills.</li><li>Effective leadership and team-building abilities across cross-functional stakeholders.</li><li>Proficiency in project management tools and planning systems.</li><li>Excellent verbal and written communication with the ability to influence at all levels.</li><li>High sense of ownership, attention to detail, and adaptability in a fast-paced, startup environment.</li><li>Commitment to compliance, quality, and patient-centered operations.</li></ul>

Responsibilities: Drives Business Growth: <ul><li>Leads commercializing solutions for new process/material innovations into manufacturing facilities.</li><li>Define, plan &amp; execute packaging trials with R&amp;D developers &amp; Manufacturing team to validate performance, quality, efficiency &amp; stability.</li><li>Identifies &amp; resolves technical &amp; material issues during commercialization.</li><li>Creates process material &amp; process specifications for the plant during handover.&nbsp;</li><li>Collaborates with Product Developers, Process Innovation, engineers, supplier &amp; Manufacturing to ensure smooth project handover.</li><li>Supports continuous improvement &amp; standardization of process process &amp; material quality specification.</li></ul> Leadership: <ul><li>Functions as a Program/Project Manager, Planner, Coordinator, Communicator, and Technical Expert.</li><li>Provides strategic input to cross-functional teams and influences decision-making through technical insights.</li></ul> Innovation / Creativity: <ul><li>Identifies &amp; implements process productivity &amp; sustainability improvements workstreams.</li><li>Collaborates with suppliers and global resources for scaling new process solutions.</li></ul> Technical Expertise: <ul><li>Serves as the subject matter expert in process engineering (equipment &amp; process flow), raw material specification &amp; Pringle chip finish goods quality.</li><li>Maintains up-to-date knowledge of current operational process technology &amp; finished process quality performance.</li></ul> People Management: <ul><li>Manages 1 direct reports, setting performance expectations, conducting evaluations, and supporting career development.</li></ul> Other Duties <ul><li>Based in Enstek Malaysia, with travel (~20%) to manufacturing sites, suppliers, and regional offices.</li><li>May require extended hours, shift work, or weekend support depending on project needs.</li><li>Occasional hands-on operation of process equipment.</li></ul> Requirements: <ul><li>Bachelor’s degree in Engineering (Chemical, Process, Mechanical, or Food), Food Science/Process /Technology degree or any related field.</li><li>Minimum 7–8 years’ experience in process development or manufacturing within the food industry. Past managerial experience is preferred.</li><li>Fluent in Bahasa Melayu &amp; English language.&nbsp;</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>

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>

Role Description:&nbsp; <ul><li>The purpose of this job is to oversee the production schedules in accordance with approved production instructions, standard operating procedures, while utilizing cGMP for the preparation of commercial product.</li><li>Monitor and document in a periodic performance review the performance of the production staff. Identify opportunities for process and equipment improvements.</li><li>Mentor staff and set goals and objectives for the production personnel.</li></ul> Responsibilities: <ul><li>Manufacturing Operations Management</li><li>Assure the accurate execution of cGMP/DEA documentation relative to manufacturing and packaging activities.</li><li>Assure the accurate manufacturing of bulk drug product for delivery to primary packaging without deviation.</li><li>Assure the accurate packaging of drug product in approved primary packaging components without deviation</li><li>Assure the accurate sampling of raw material and the packaging of samples for shipment as appropriate to contract testing laboratories.</li><li>Assure the accurate assessment of component inventory and reconciliation.</li><li>Assure staff training requirements are established and complete prior to the performance of process or procedure.</li><li>Assure the accurate performance of basic routine preventive maintenance of equipment and facility cleaning activities by operators.</li><li>Establish performance Goals and Objectives based on facility needs and High Corporate Standards.</li><li>Complete routine performance evaluations of staff, and recommend growth opportunities.</li><li>Assure adherence to established production schedules and monitor production performance as determined by the Plant Director.</li><li>Monitor the general safety of staff and assure safe work practices are followed by all site personnel.</li></ul> Requirements: Education &amp; Experience <ul><li>Undergraduate Degree in Pharmacy, Engineering, or equivalent in training and experience.</li><li>10 years’ experience in a pharmaceutical manufacturing environment.</li><li>Prior cGMP experience in a pharmaceutical production environment is necessary. 3-5 years’ previous supervisory experience required.</li><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li></ul> Knowledge&nbsp; <ul><li>Knowledge of workplace health and safety requirements for applicable hazardous substances.</li><li>Must be able to demonstrate a high degree of understanding in the cGMP practices.</li><li>Must be able to demonstrate a high degree of understanding in the controlled drug substance regulations.</li><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li></ul> Skills &amp; Abilities <ul><li>Demonstrate knowledge of the current good manufacturing practices.</li><li>Ability to convey information clearly and concisely to both individuals and groups.</li><li>Ability to troubleshoot manufacturing processes, write investigations and complete documentation.</li><li>Ensure adequate staffing and efficient workflow and provide reports and data on manufacturing activity.</li></ul> Physical Requirements	 <ul><li>This position requires working with or around hazardous substances, and is subject to work restrictions and precautions as set forth in the Safety Data Sheet, provided to all affected employees.</li><li>Ability to don personal protective equipment, if necessary. Able to walk the production floor.</li><li>This position requires working with or around hazardous substances, and is subject to work restrictions and precautions as set forth in the Safety Data Sheet, provided to all affected employees.</li><li>Ability to don personal protective equipment, if necessary.</li><li>Able to walk the production floor.</li></ul>

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17 packaging Jobs found

Production Technician I

Compounding Technician

Filling Technician

Junior Graphic Designer (Contractual)

Production Supervisor

Manager, Site Logistics & Project Integration

Process Technologist Manager (GL3)

Process Mechanic – Sterile Filling & Packaging

Technical Support Manager

Manager, Operations

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17 packaging Jobs found

Production Technician I

Compounding Technician

Filling Technician

Junior Graphic Designer (Contractual)

Production Supervisor

Manager, Site Logistics & Project Integration

Process Technologist Manager (GL3)

Process Mechanic – Sterile Filling & Packaging

Technical Support Manager

Manager, Operations

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