{"schemaVersion":"jobsearcher.job.v1","id":"e2f7c74973b6f6e599dd188d","url":"https://jobsearcher.com/jobs/e2f7c74973b6f6e599dd188d","canonicalUrl":"https://jobsearcher.com/jobs/e2f7c74973b6f6e599dd188d","title":"Process Engineer","description":"York, United States | Posted on 08/27/2026\n\nBioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services. From IND applications through commercial scale production, we provide formulation and compounding, fill-finish, and lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team’s expertise to create a process design for our clients’ products that best suits their needs.\n\nThe Experience\nWith operations spanning the globe and featuring a multi-cultural team, BioTechnique is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.\n\nWe are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered a compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.\n\nAt BioTechnique, it’s about more than just a job—it’s about your career and your future.\n\nYour Role\nBioTechnique is seeking a highly motivated Process Engineer (Mid-Level to Senior-Level) to support aseptic manufacturing, technology transfer, process validation, and continuous improvement activities within our sterile injectable CDMO operations. This role serves as a technical leader responsible for translating client manufacturing processes into robust, scalable, and compliant commercial operations.\n\nThe Process Engineer will collaborate across Manufacturing, Quality, Validation, Facilities, Metrology, Supply Chain, and Client Project Teams to support aseptic fill-finish programs from development through commercial production. The successful candidate will possess a strong understanding of aseptic processing, sterile manufacturing, cGMP requirements, process validation, and pharmaceutical engineering principles.\n\nProcess Development & Technology Transfer\n\nLead process transfer activities from clients into BioTechnique manufacturing operations.\n\nReview client process documentation, batch records, process descriptions, and development reports.\n\nDevelop manufacturing process strategies for aseptic fill-finish, sterile filtration, compounding, lyophilization, and packaging operations.\n\nAuthor and review technology transfer protocols, reports, risk assessments, and process characterization documents.\n\nSupport engineering runs, water runs, media fills, and demonstration batches.\n\nManufacturing Support\n\nProvide floor support during aseptic manufacturing campaigns.\n\nTroubleshoot process deviations, equipment issues, yield losses, and process excursions.\n\nSupport investigations, CAPAs, and root cause analyses.\n\nDrive process improvements that increase throughput, quality, and operational efficiency.\n\nProvide technical leadership during critical manufacturing operations.\n\nProcess Validation\n\nAuthor and execute:\n\nProcess Validation Master Plans (PVMP)\n\nPPQ Protocols and Reports\n\nContinued Process Verification (CPV) Programs\n\nProcess Risk Assessments\n\nMedia Fill Protocols\n\nAnalyze process data and recommend improvements based on statistical and scientific principles.\n\nSupport successful execution of PPQ campaigns.\n\nAseptic Processing Support\n\nSupport aseptic processing programs in compliance with:\n\nFDA cGMP regulations\n\nEU GMP Annex 1\n\nICH Guidelines\n\nUSP requirements\n\nParticipate in aseptic process simulations (APS/media fills).\n\nEvaluate smoke studies, environmental monitoring trends, contamination control strategies, and operator qualification programs.\n\nSupport contamination control and sterility assurance initiatives.\n\nEquipment & Facility Engineering\n\nSupport qualification and implementation of:\n\nFilling lines\n\nIsolators\n\nRABS systems\n\nCIP/SIP systems\n\nSterile filtration systems\n\nVisual inspection systems\n\nCollaborate with Validation and Facilities teams during IQ/OQ/PQ activities.\n\nAssess equipment performance and recommend improvements.\n\nSupport cycle development, scale-up, and process optimization activities.\n\nReview thermal characterization and freeze-drying data.\n\nSupport lyo process validation and technology transfer projects.\n\nInvestigate cycle anomalies and process variability.\n\nLead Lean Manufacturing and Operational Excellence initiatives.\n\nUtilize data analytics and process monitoring tools to improve performance.\n\nImplement process robustness and reliability improvements.\n\nRegulatory & Audit Support\n\nSupport internal and external audits.\n\nParticipate in client audits and regulatory inspections.\n\nProvide SME support during FDA and customer inspections.\n\nPrepare technical documentation for regulatory submissions when required.\n\nRequirements\n\nBachelor's degree in: Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, Biotechnology, Related Engineering Discipline\n\n4-8 years of pharmaceutical manufacturing experience\n\nMinimum 3 years supporting aseptic manufacturing operations.\n\nMust be authorized to work in the U.S.\n\nNo C2C at this time.\n\nDemonstrated experience with:\n\nSterile injectable manufacturing\n\nFill-finish operations\n\nGMP documentation\n\nProcess investigations\n\nTechnology transfer\n\nProcess validation\n\nPreferred\n\nExperience in a CDMO environment.\n\nExperience supporting biologics, vaccines, mAbs, gene therapy products, peptides, or sterile small molecules.\n\nExperience with lyophilization cycle development and optimization.\n\nFamiliarity with Annex 1 contamination control requirements.\n\nSix Sigma Green Belt or Black Belt certification.\n\nOffering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.\n\nMedical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents\n\nInsurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.\n\n401(k) and 401(k) matching\n\nPTO, Sick Time, and Paid Holidays\n\nEducation Assistance\n\nPet Insurance\n\nFitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more)\n\nFinancial Perks and Discounts\n\nEqual Opportunity Employment Statement\nPSC is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.\n\n#J-18808-Ljbffr","company":"Psc Biotech","rawCompany":"psc biotech","city":"Brooklyn","state":"NY","isRemote":false,"isActive":false,"createdAt":"2026-09-02T03:33:52.829Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2041.00","title":"Chemical Engineers","slug":"chemical-engineers"}],"industries":[{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Process Engineer","description":"York, United States | Posted on 08/27/2026\n\nBioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services. From IND applications through commercial scale production, we provide formulation and compounding, fill-finish, and lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team’s expertise to create a process design for our clients’ products that best suits their needs.\n\nThe Experience\nWith operations spanning the globe and featuring a multi-cultural team, BioTechnique is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.\n\nWe are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered a compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.\n\nAt BioTechnique, it’s about more than just a job—it’s about your career and your future.\n\nYour Role\nBioTechnique is seeking a highly motivated Process Engineer (Mid-Level to Senior-Level) to support aseptic manufacturing, technology transfer, process validation, and continuous improvement activities within our sterile injectable CDMO operations. This role serves as a technical leader responsible for translating client manufacturing processes into robust, scalable, and compliant commercial operations.\n\nThe Process Engineer will collaborate across Manufacturing, Quality, Validation, Facilities, Metrology, Supply Chain, and Client Project Teams to support aseptic fill-finish programs from development through commercial production. The successful candidate will possess a strong understanding of aseptic processing, sterile manufacturing, cGMP requirements, process validation, and pharmaceutical engineering principles.\n\nProcess Development & Technology Transfer\n\nLead process transfer activities from clients into BioTechnique manufacturing operations.\n\nReview client process documentation, batch records, process descriptions, and development reports.\n\nDevelop manufacturing process strategies for aseptic fill-finish, sterile filtration, compounding, lyophilization, and packaging operations.\n\nAuthor and review technology transfer protocols, reports, risk assessments, and process characterization documents.\n\nSupport engineering runs, water runs, media fills, and demonstration batches.\n\nManufacturing Support\n\nProvide floor support during aseptic manufacturing campaigns.\n\nTroubleshoot process deviations, equipment issues, yield losses, and process excursions.\n\nSupport investigations, CAPAs, and root cause analyses.\n\nDrive process improvements that increase throughput, quality, and operational efficiency.\n\nProvide technical leadership during critical manufacturing operations.\n\nProcess Validation\n\nAuthor and execute:\n\nProcess Validation Master Plans (PVMP)\n\nPPQ Protocols and Reports\n\nContinued Process Verification (CPV) Programs\n\nProcess Risk Assessments\n\nMedia Fill Protocols\n\nAnalyze process data and recommend improvements based on statistical and scientific principles.\n\nSupport successful execution of PPQ campaigns.\n\nAseptic Processing Support\n\nSupport aseptic processing programs in compliance with:\n\nFDA cGMP regulations\n\nEU GMP Annex 1\n\nICH Guidelines\n\nUSP requirements\n\nParticipate in aseptic process simulations (APS/media fills).\n\nEvaluate smoke studies, environmental monitoring trends, contamination control strategies, and operator qualification programs.\n\nSupport contamination control and sterility assurance initiatives.\n\nEquipment & Facility Engineering\n\nSupport qualification and implementation of:\n\nFilling lines\n\nIsolators\n\nRABS systems\n\nCIP/SIP systems\n\nSterile filtration systems\n\nVisual inspection systems\n\nCollaborate with Validation and Facilities teams during IQ/OQ/PQ activities.\n\nAssess equipment performance and recommend improvements.\n\nSupport cycle development, scale-up, and process optimization activities.\n\nReview thermal characterization and freeze-drying data.\n\nSupport lyo process validation and technology transfer projects.\n\nInvestigate cycle anomalies and process variability.\n\nLead Lean Manufacturing and Operational Excellence initiatives.\n\nUtilize data analytics and process monitoring tools to improve performance.\n\nImplement process robustness and reliability improvements.\n\nRegulatory & Audit Support\n\nSupport internal and external audits.\n\nParticipate in client audits and regulatory inspections.\n\nProvide SME support during FDA and customer inspections.\n\nPrepare technical documentation for regulatory submissions when required.\n\nRequirements\n\nBachelor's degree in: Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, Biotechnology, Related Engineering Discipline\n\n4-8 years of pharmaceutical manufacturing experience\n\nMinimum 3 years supporting aseptic manufacturing operations.\n\nMust be authorized to work in the U.S.\n\nNo C2C at this time.\n\nDemonstrated experience with:\n\nSterile injectable manufacturing\n\nFill-finish operations\n\nGMP documentation\n\nProcess investigations\n\nTechnology transfer\n\nProcess validation\n\nPreferred\n\nExperience in a CDMO environment.\n\nExperience supporting biologics, vaccines, mAbs, gene therapy products, peptides, or sterile small molecules.\n\nExperience with lyophilization cycle development and optimization.\n\nFamiliarity with Annex 1 contamination control requirements.\n\nSix Sigma Green Belt or Black Belt certification.\n\nOffering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.\n\nMedical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents\n\nInsurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.\n\n401(k) and 401(k) matching\n\nPTO, Sick Time, and Paid Holidays\n\nEducation Assistance\n\nPet Insurance\n\nFitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more)\n\nFinancial Perks and Discounts\n\nEqual Opportunity Employment Statement\nPSC is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.\n\n#J-18808-Ljbffr","datePosted":"2026-09-02T03:33:52.829Z","dateModified":"2026-09-02T03:33:52.829Z","hiringOrganization":{"@type":"Organization","name":"Psc Biotech","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Brooklyn","addressRegion":"NY","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"e2f7c74973b6f6e599dd188d"},"url":"https://jobsearcher.com/jobs/e2f7c74973b6f6e599dd188d"}}