Manager – R&D F&D Emulsions

Reference Standard Coordinator

Senior Software Engineer

Principal Software Engineer

Buyer II

Accounts Payable Manager

Process Mechanic – Sterile Filling & Packaging

Facility Engineer

Document Control Lead

Process Equipment Engineer

Job Description: <ul><li>The role of a Manager – R&amp;D (Research &amp; Development) F&amp;D (Food &amp; Drink) Emulsions typically involves overseeing the research, development, and innovation of emulsions used in the food and beverage industry.&nbsp;</li><li>The manager leads the R&amp;D team to develop new emulsion-based products or improve existing ones to meet customer requirements, industry standards, and market demands.</li></ul> Responsibilities: Planning of Project technical feasibility experiment: <ul><li>End to end planning for Resource availability on time Planning of developmental trials, PDR studies/QBD additional studies for ANDA products</li><li>Planning of developmental trials, PDR studies/QBD additional studies for ANDA products.</li><li>Monitoring of development trials.</li><li>Compilation of the development data.</li><li>Ensuring development as per QBD approach</li><li>Review the technical documents e.g. DMBD, PDR and other protocols &amp; reports.</li><li>Coordination with CFTs (ADL, IRA, Procurement, Quality) for on time project execution.</li><li>Technology transfer of Drug product [ANDA, 505 (b)(2), Complex injectables]</li><li>Exhibit batch execution [ANDA, 505 (b)(2), Complex injectables]</li><li>Support for Process validation and commercial batches [ANDA, 505 (b)(2), Complex injectables]</li><li>Technology transfer documents review Products developed by CRO as per regulatory requirement.</li><li>Support &amp; coordination with CMOs for successful technology transfer</li><li>Fulfilling the regulatory requirements by designing the trials</li><li>Training &amp; knowledge enhancement of the team</li><li>Design &amp; Authorization of SOPs</li><li>Execution &amp; approval process of New Equipments/Instruments for projects in upcoming portfolio &amp; continuous improvement of Development Lab.</li><li>Adoption of GQP (Procedures integration with systems)</li></ul> Requirements: <ul><li>3–4 years of team handling experience</li><li>3–4 years of hands-on work in emulsions (oil-based and water-based)</li><li>Full product lifecycle exposure: development → scale-up → filing</li><li>Minimum 5–10 regulatory filings (e.g., ANDA, NDA)</li><li>Strong people management and leadership capabilities</li><li>Preferred experience in ophthalmic formulations</li><li>Background in injectable manufacturing environment is an added plus</li></ul>

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

Role Description: <ul><li>Dive into the forefront of innovation with our Gateway Security team, where we scan massive volumes of email traffic for our customers! Our pioneering Email Platform pushes on the boundaries of what’s possible, leveraging the latest technologies and tooling in AWS.</li></ul> Responsibilities: <ul><li>Implement Jenkins pipelines with modern CI/CD workflows</li><li>Create properly tuned alerts and dashboards to effectively monitor infrastructure and service health in production</li><li>Champion and leverage Infrastructure as Code technologies as a way of life</li><li>Contribute strongly to cloud migration efforts, bringing more and more capabilities into our standard AWS infrastructure</li><li>Write scripts and automated tests to ensure the resilience and quality of Mimecast solutions</li><li>Innovate and champion improvements in QE and CI/CD processes and tools</li></ul> Requirements: Experience <ul><li>7+ years of experience in a complex, multi-disciplinary environment, delivering products within specific time-scales and engaging with multiple senior stakeholders</li><li>Transform Product requirements into features/enhancements working with architects, Product Management and cross teams</li><li>Deliver AWS based Java services through CI/CD and Infrastructure as code using Terraform</li><li>Deploy, Monitor and analyze AWS usage, providing recommendations for cost optimisations without compromising system performance and reliability</li><li>Refactor monolithic applications into a microservices/k8s architecture</li><li>Provide support during critical production incidents and implement preventive measures</li><li>Demonstratable expertise in Java development, with a strong command of Java 11 and above</li><li>Proven experience in designing, developing, and optimizing backend systems for data processing at scale within AWS</li><li>In-depth knowledge and hands-on experience with AWS services, such as; ALB, S3, ElastiCache, IAM, CloudWatch, DynamoDb, EKS</li><li>Knowledge and experience on Kubernetes is must</li><li>Experience in building scalable, distributed REST/HTTP-based microservices on hybrid cloud environments</li></ul>

Role Description: <ul><li>Dive into the forefront of innovation with our Gateway Security team, where we scan massive volumes of email traffic for our customers! Our pioneering Email Platform pushes on the boundaries of what’s possible, leveraging the latest technologies and tooling in AWS.</li></ul> Responsibilities: <ul><li>Deliver AWS based Java services through CI/CD and Infrastructure as code using Terraform.</li><li>Deploy, Monitor and analyze AWS usage, providing recommendations for cost optimisations without compromising system performance and reliability.</li><li>Refactor monolithic applications into a microservices/k8s architecture.</li><li>Provide support during critical production incidents and implement preventive measures.</li></ul> Requirements: <ul><li>10+ years of experience in a complex, multi-disciplinary environment, delivering products within specific time-scales and engaging with multiple senior stakeholders.</li><li>Transform Product requirements into features/enhancements working with architects, Product Management and cross teams.</li><li>Demonstratable expertise in Java development, with a strong command of Java 11 and above</li><li>Proven experience in designing, developing, and optimizing backend systems for data processing at scale within AWS.</li><li>In-depth knowledge and hands-on experience with AWS services, such as; ALB, S3, ElastiCache, IAM, CloudWatch, DynamoDb, EKS.</li><li>Knowledge and experience on Kubernetes is must.</li><li>Experience in building scalable, distributed REST/HTTP-based microservices on hybrid cloud environments.</li></ul>

Responsibilities: <ul><li>Support migration of Indirect Procurement processes from other Global countries to Alabang and prepare Indirect Procurement related process documentation (process maps and work instructions)</li><li>Become a Subject Matter Expert for Indirect Procurement related topics</li><li>Handle and resolve escalated procurement processing issues</li><li>Answer and resolve suppliers, stakeholders and AP queries to ensure timely resolution</li><li>Maintain supplier master data information in relevant systems</li><li>Ensure proper processing of PR’s and PO’s</li><li>Perform compliance checks</li><li>Expedite POs</li><li>Answer tickets (Procurement Helpdesk)</li><li>Manage invoice pricing issues</li><li>Create, maintain Info Record &amp; source lists</li><li>Spot Buy / Requisition Based Sourcing</li><li>Execute all procurement activities in-scope</li><li>Prepare and process eRFQ’s</li><li>Smaller Contract (value/complexity) negotiation &amp; execution</li><li>Execution of Projects assigned by Commodity Management</li><li>Desk Research and Price Comparison</li><li>Supplier training on tools</li><li>End-user Trainings</li><li>Savings reporting</li><li>Maintain communication with suppliers, stakeholders and other Indirect Procurement members</li><li>Execute periodically PR/PO audit queries or upon request KPI’s measurements</li><li>Ensure compliance with applicable client policies</li><li>Contribute to continuous improvement initiatives within the function, ensuring that improvements are incorporated in the work routine</li><li>Support robust compliance environment with applicable policies, procedures and processes</li><li>Build relationship with key stakeholders including suppliers</li><li>Support local BU owners, Function representatives or other Procurement team members to solve issues in a timely manner,</li><li>Build strong relationship with key stakeholders,</li><li>Attend team meetings and trainings as required.</li></ul> Requirements: <ul><li>Good Experience in Indirect Procurement (5+ years)</li><li>Previous experience in shared service environment</li><li>Good of MS office; very good Excel and other relevant tools for the function</li><li>SAP PR2, S/4</li><li>Good communication skills</li><li>Very good English language skills in speech and writing + additional language on top of Filipino preferred (Chinese, Spanish, German, French, etc.)</li><li>Diversified Industrial Products/Manufacturing industry experience preferred</li><li>Good command of other languages is a very important asset</li><li>Experience in a procurement shared service center supporting multiple countries / business units</li><li>Experience working for a Manufacturing company preferred</li><li>Good understanding of end-to-end S2P processes and associated technology platforms</li><li>Excellent organizational and analytical skills, solid problem solving and detail oriented</li><li>Strong communication skills</li><li>Ability to work with deadlines</li><li>Ability to work in culturally diverse teams with many levels of personnel.</li></ul>

Responsibilities: <ul><li>Lead, mentor, and develop the S2P Team Lead Associate and Associates.</li><li>Conduct regular performance reviews, coaching, and feedback sessions.</li><li>Monitor the invoice-to-pay cycle to guarantee timely and error-free payment processing.</li><li>Collaborate with regional Finance Controllers/Directors to identify and resolve issues.</li><li>Develop, maintain, and track operational metrics, scorecards, and KPIs aligned with SLAs.</li><li>Drive process automation and digital tool adoption to improve efficiency.</li><li>Identify and implement continuous improvement initiatives across S2P operations.</li><li>Build strong collaborative relationships with Global Process Owners and stakeholders.</li><li>Ensure compliance with tax regulations, internal controls, and corporate policies.</li><li>Support standardization and optimization of processes across supported entities.</li><li>Manage month-end close activities and A/P reporting.</li><li>Promote a culture of continuous learning, accountability, and high performance.</li></ul> Competencies &amp; Skills <ul><li>Strong understanding of end-to-end Source-to-Pay processes and enabling technologies.</li><li>Conflict resolution, team development, and motivation skills.</li><li>Strong communication and stakeholder management skills across internal and external partners.</li><li>Ability to influence and negotiate at various organizational levels.</li><li>Strong analytical and problem-solving capabilities.</li><li>Experience in leading organizational change and transformation initiatives.</li><li>Proficiency in English (and local language as applicable).</li><li>Strong skills in performance management, audit readiness, and risk mitigation.</li><li>Comfort with ambiguity, adaptability, and driving change in dynamic environments.</li><li>Strong collaboration mindset with focus on value creation and efficiency.</li><li>Proficiency in SAP; knowledge of ServiceNow (SNOW) is a plus.</li></ul>&nbsp;Requirements: Experience &amp; Educational Requirements <ul><li>5–7 years of relevant experience in a Financial Solutions Center supporting multiple countries/business units (preferably in industrial/manufacturing industries).</li><li>3–5 years of leadership/managerial experience, ideally within shared services or global business services.</li><li>Proven track record in achieving KPIs, SLAs, and customer satisfaction goals.</li><li>Strong accounting background with deep A/P and compliance knowledge.</li><li>Graduate degree in Finance, Accounting, or equivalent experience.</li><li>Experience in managing culturally diverse, global teams.</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>

Role Description: <ul><li>The Facility Engineer will play a critical role in the greenfield design, construction, startup, and long-term operation of a state-of-the-art sterile injectable IV bag manufacturing facility. This role will lead the implementation and management of all facility infrastructure systems, including cleanrooms, HVAC, utilities, building automation, environmental monitoring, chemistry and microbiology lab systems, and energy management, ensuring full compliance with cGMP standards and regulatory expectations for sterile manufacturing.</li><li>The Facility Engineer will collaborate with cross-functional teams during construction, commissioning, qualification, and beyond, ensuring the facility infrastructure reliably supports sterile production, patient safety, and long-term business goals.</li></ul> Responsibilities: <ul><li>Lead the design review, specification development, and technical oversight of facility infrastructure systems including cleanrooms, HVAC, compressed air, chilled water, WFI, clean steam, and other critical utilities.</li><li>Develop and maintain facility engineering standards, equipment specifications, and technical documentation aligned to regulatory requirements and aseptic processing standards.</li><li>Oversee construction, installation, commissioning, and qualification of facility utilities and infrastructure systems, ensuring timely, compliant project execution.</li><li>Collaborate with Validation, Quality, and Operations teams to ensure proper facility qualification (IQ/OQ/PQ) and environmental monitoring readiness.</li><li>Promote and ensure adherence to safety protocols and safe work practices.</li><li>Perform risk assessments for engineering and maintenance activities.</li><li>Establish and manage preventative maintenance programs, calibration schedules, and facilities management SOPs to ensure optimal equipment performance and facility reliability.</li><li>Provide technical expertise in troubleshooting facility system deviations, non-conformances, and CAPAs, ensuring timely resolution and sustained compliance.</li><li>Partner with EHS, Operations, and Quality to ensure all facility systems meet safety, regulatory, and operational expectations.</li><li>Manage relationships with external engineering firms, contractors, and utility service providers to ensure effective delivery of construction and facility services. 11.	Support energy management, sustainability initiatives, and continuous improvement efforts to optimize facility operating costs and resource utilization.</li><li>Ensure ongoing regulatory inspection readiness and serve as SME for facility systems during audits and inspections.</li></ul> Requirements: Qualifications/Experience: <ul><li>Bachelor’s degree in mechanical, Electrical, Industrial, or Facilities Engineering.</li><li>3+ years of relevant experience in pharmaceutical or sterile manufacturing facility engineering.</li><li>Strong technical knowledge of facility infrastructure systems including HVAC for aseptic manufacturing, cleanrooms, and critical utilities.</li><li>Direct experience with greenfield facility construction, commissioning, and qualification highly desirable.</li><li>Solid understanding of FDA cGMP regulations, USP standards, and applicable environmental, health, and safety requirements.</li></ul> Skills/Competencies: <ul><li>Expertise Experience in facility system design, commissioning, and lifecycle maintenance.</li><li>Strong project management and contractor/vendor coordination capabilities.</li><li>Excellent problem-solving and root cause analysis skills.</li><li>Strong understanding of aseptic manufacturing facility requirements and environmental controls.</li><li>Effective communication and cross-functional collaboration skills.</li><li>High attention to detail, safety, and compliance.</li><li>Ability to thrive in a dynamic greenfield/startup environment.</li></ul>

Role Description: <ul><li>The Document Control Lead will serve as a key quality function responsible for establishing, maintaining, and managing the document control systems critical to ensuring regulatory compliance, data integrity, and operational readiness for a greenfield sterile injectable IV bag manufacturing facility.</li><li>This role will drive the creation, organization, distribution, and maintenance of all controlled documentation required to support GMP operations, regulatory submissions, and inspection readiness.</li><li>The incumbent will play a vital role in building document management systems during site startup and ensure robust control throughout the facility lifecycle.</li><li>This role will also be the site technical resource for coordination and qualification of corporate quality electronic document systems including Trackwise, Learning Management System, and the Document Control System.</li></ul> Responsibilities: <ul><li>Develop and implement comprehensive document control systems aligned with FDA cGMP, ICH, ISO, and company quality standards.</li><li>Manage the creation, review, approval, issuance, and archival of controlled documents including SOPs, batch records, forms, protocols, and reports.</li><li>Establish electronic document management systems (EDMS) and ensure proper system validation and security controls are in place.</li><li>Lead training initiatives for site personnel on document control processes, document authoring standards, and compliance requirements.</li><li>Coordinate cross-functional document reviews, version control, change management, and timely issuance of current documents to ensure operational readiness.</li><li>Monitor and ensure compliance with controlled document workflows, ensuring timely processing and adherence to procedural timelines.</li><li>Support regulatory inspections, internal audits, and external audits by providing controlled document access, retrieval, and documentation support.</li><li>Maintain accurate and organized archives (both physical and electronic) to ensure data integrity, traceability, and inspection readiness.</li><li>Collaborate with Quality Assurance, Validation, Operations, Engineering, and Regulatory Affairs to ensure alignment of document control processes.</li><li>Continuously improve document control processes, leveraging automation, best practices, and compliance trends to ensure long-term system robustness.</li></ul> Requirements: Qualifications/Experience: <ul><li>Bachelor’s degree in Life Sciences, Quality Management, or related field.</li><li>5+ years of experience in GMP-regulated pharmaceutical document control, preferably in sterile manufacturing.</li><li>Prior experience implementing or managing electronic document management systems (EDMS) strongly preferred.</li><li>Strong understanding of FDA cGMP, ICH, ISO 9001, and data integrity principles.</li><li>Experience supporting regulatory inspections and audits.</li></ul> Skills/Competencies: <ul><li>Expertise in controlled document management principles and electronic systems.</li><li>Strong attention to detail, accuracy, and compliance.</li><li>Excellent organizational and time management skills.</li><li>Ability to manage multiple priorities and document workflows simultaneously.</li><li>Strong cross-functional collaboration and communication skills.</li><li>Proficiency in EDMS platforms, document lifecycle management, and version control.</li><li>Ability to work in a greenfield/startup environment and build systems from the ground up.</li></ul>

Role Description: <ul><li>The Process Equipment Engineer will be a key technical leader responsible for the design, specification, procurement, installation, qualification, and ongoing reliability of process equipment for a greenfield sterile injectable IV bag manufacturing facility.</li><li>This role will play a critical part in ensuring that all manufacturing equipment all sterile manufacturing equipment are compliant with cGMP requirements, supports aseptic processing standards, and are capable of delivering high-quality product performance from day one of commercial operations. </li><li>Equipment includes sterile isolators, compounding, automated inspection, and secondary packaging for the production of sterile IV bags.</li><li>Working cross-functionally during the startup phase, the incumbent will drive equipment readiness, validation support, and serve as a technical subject matter expert (SME) for process equipment throughout the facility lifecycle.</li></ul> Responsibilities: <ul><li>Lead the specification, selection, and procurement of sterile injectable manufacturing process equipment, including isolator filling lines, formulation vessels, mixing systems inspection equipment, secondary packaging equipment, and associated support systems.</li><li>Develop user requirement specifications (URS), functional specifications (FS), and detailed equipment design documentation in compliance with regulatory and operational standards.</li><li>Manage equipment vendors, design reviews, factory acceptance testing (FAT), site acceptance testing (SAT), and oversee equipment delivery, installation, and commissioning.</li><li>Promote and ensure adherence to safety protocols and safe work practices.</li><li>Perform risk assessments for engineering and maintenance activities.</li><li>Collaborate with Validation, Quality, and Operations teams to support equipment qualification (IQ/OQ/PQ) and ensure all systems meet regulatory expectations for sterile manufacturing.</li><li>Establish preventative maintenance programs, spare parts inventories, and equipment lifecycle management plans to ensure long-term equipment reliability and availability.</li><li>Provide technical expertise during troubleshooting, deviations, and investigations related to process equipment performance, ensuring rapid resolution of issues.</li><li>Partner with Manufacturing and Quality teams to optimize equipment performance, drive continuous improvement initiatives, and support ongoing process optimization.</li><li>Identify and implement process improvements to enhance operational safety, efficiency, and reliability.</li><li>Support development of SOPs, equipment manuals, and operator training programs to ensure safe and compliant operation of process equipment.</li><li>Ensure equipment designs fully comply with cGMP, FDA, OSHA, and all applicable regulatory and safety standards.</li><li>Contribute to capital project planning, budgeting, and project execution related to new equipment or facility expansions.</li><li>Ensure ongoing regulatory inspection readiness and serve as SME for process systems during audits and inspections.</li></ul> Requirements: <ul><li>Bachelor’s degree in mechanical engineering, Chemical Engineering, Industrial Engineering, or related field.</li><li>3+ years of experience in pharmaceutical process equipment engineering, with significant exposure to sterile injectable manufacturing strongly preferred.</li><li>Direct experience with design, procurement, and qualification of aseptic manufacturing equipment and cleanroom environments.</li><li>Solid understanding of cGMP regulations, FDA/EMA expectations, and engineering best practices for sterile operations.</li><li>Experience working in greenfield or major facility expansion projects highly desirable.</li></ul> Skills/Competencies: <ul><li>Strong technical knowledge of process equipment design, aseptic manufacturing, and utility systems.</li><li>Proven project management skills with ability to handle complex, cross-functional projects.</li><li>Excellent problem-solving abilities and root cause investigation experience.</li><li>Effective communication and vendor management skills.</li><li>Ability to work independently in a fast-paced, startup-like environment.</li><li>Strong teamwork, collaboration, and continuous improvement mindset.</li><li>High attention to detail with strong commitment to safety, compliance, and product quality.</li></ul>

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53 food processing Jobs found

Manager – R&D F&D Emulsions

Reference Standard Coordinator

Senior Software Engineer

Principal Software Engineer

Buyer II

Accounts Payable Manager

Process Mechanic – Sterile Filling & Packaging

Facility Engineer

Document Control Lead

Process Equipment Engineer

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Skills

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53 food processing Jobs found

Manager – R&D F&D Emulsions

Reference Standard Coordinator

Senior Software Engineer

Principal Software Engineer

Buyer II

Accounts Payable Manager

Process Mechanic – Sterile Filling & Packaging

Facility Engineer

Document Control Lead

Process Equipment Engineer

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

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TALENT

COMPANY

Contact Us

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