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$150 per hour
...EMS, FDA regulations, company policies, and operating procedures.Develop and execute process and test method validations (IQ, OQ, PQ, PPQ).Prepare and review documentation such as specifications, manufacturing procedures, and technical reports.Communicate effectively...SuggestedWork at office$90k - $210k
...manufacture and disposition products to patients in a timely mannerLead and oversee manufacturing processes including engineering runs, PPQ and APSEnsure manufacturing processes in both an R&D and GMP environments are following appropriate protocols and/or standard...SuggestedFull timeFlexible hoursShift work- ...regulatory requirementsPlans, Develops, and ensures resources are adequate to execute Process and Test Method Validations (IQ, OQ, PQ, PPQ) in accordance with Integer procedures and guidelinesCommunicates procedures, policies, improvement ideas, technical information, and...SuggestedFull timeImmediate start
- ...Ensure adherence to Good Documentation Practices (GDP) and support maintenance shutdowns as needed.Execute validation activities (IOQ, PPQ) with minimal supervision.Identify and implement continuous improvement opportunities in manufacturing systems and processes....SuggestedFull timeTemporary workLocal areaFlexible hoursShift workDay shift
- ...procurement, technology transfer, automation/digital, and operations leaders, the role will ensure the site is prepared for handover, PPQ, and facility approval through disciplined execution of SOPs, training, tech transfer alignment, incoming materials readiness,...SuggestedFull timeLocal area
- ...development and qualification, process characterization, and process control strategy definition to enable process performance qualification (PPQ) readiness for both drug substance and drug product manufacturing campaigns. This position is highly collaborative and will require...SuggestedFull timeContract workWork at officeLocal area
$276.3k - $373.8k
...ICH, and global regulatory expectations. Provide Quality leadership for facility start-up, commissioning, qualification, validation, PPQ, technology transfer, and ongoing manufacturing operations. Acts as the strategic Quality partner cross-functionally with Manufacturing...SuggestedFull timeTemporary workLocal areaFlexible hours$213k - $250k
...GMP-supporting analytical activities.Support QC and ASAT teams in technical questions related to release, stability, comparability, PPQ, method transfer, validation readiness, and commercial readiness activities.Develop phase-appropriate immunoassay strategies across the...SuggestedContract work- ...activities for pre-filled syringe (PFS) manufacturing lines. The ideal candidate will have strong experience with aseptic processing, PPQ execution, and cross-functional collaboration to ensure successful project delivery and regulatory compliance. Responsibilities:...Suggested
$189k - $246k
...Responsibilities:Provide technical oversight of API production, scale up, process characterization, and process performance qualification (PPQ) for a small molecule, solid oral drug product manufactured at Travere CDMOs.Review and approve manufacturing-related documentation,...SuggestedFull timeTemporary work- ...successfully implementing appropriate KPI mechanisms and accountability. Experience with technology transfers, batch release, stability and PPQ preferred.Proven ability to operate at both strategic and operational levels in fast growth, ambiguous environments.Strong financial...SuggestedFull timeTemporary workWork at officeLocal areaShift work3 days per week
- ...and optimize processes and line performance.Create and revise manufacturing-related validation and risk documents including IQ/OQ/PQ/PPQ protocols, Process FMEAs, Manufacturing Line Specifications, Equipment Specifications.QualificationsRequired Skills and ExperienceStrong...SuggestedLocal areaWorldwideFlexible hours
- ...the Technical Operations team. Responsible for design and execution of process verification and validation activities (IQ/OQ/PQ, PV, PPQ) aligned with regulatory expectations (FDA QSR, IVDR)Implement a quality by design (QBD) approach and mindset into the team.Ensure processes...SuggestedLocal areaWorldwide
$90k - $120k
..., and production requirements. Lead onboarding and integration of new commercial clients as programs transition from development and PPQ into routine commercial manufacturing. Develop and implement scalable account management, forecasting, and planning processes to support...SuggestedFull timeWork at officeLocal areaWorldwideMonday to FridayShift workDay shift- ...unscheduled problems and repairs to ensure equipment uptime and availability.Develop and execute validation protocols (IQ/OQ/DQ/PQ and PPQ) for equipment and automated assembly lines; maintain compliant records.Determine and analyze equipment performance trends; define...SuggestedLocal areaWorldwideFlexible hoursShift work
$186k - $233k
...Responsibilities:Provide QA oversight and approval of validation lifecycle activities, including Process Performance Qualification (PPQ), Continued Process Verification (CPV), cleaning validation, packaging validation, transportation/shipping validation, and ongoing process...Full timeWork at officeLocal area$96k - $144k
...Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Performance Qualification (PPQ) for the Schneider Electric EMS package.Documentation & Compliance: Develop and maintain comprehensive validation documentation such...Ongoing contractFull timeTemporary workWork at officeRemote workFlexible hours- ...product transfers and volume ramps while maintaining rigorous quality standards.Uphold best practices for Product/Process Qualifications (PPQ) and Change Management to ensure customer protection and product integrity.Assist in preparation and hosting of customer visits and...Full timeLocal area
$174k - $203k
...commercial manufacturing.Essential Functions:Process Validation LeadershipProvide strategic and scientific leadership for process validation (PPQ, CPV, lifecycle validation) across commercial programs.Lead and facilitate execution of validation strategies to support technology...$190k - $220k
...attributes, and control strategy needs.Support QC and ASAT teams in technical questions related to release, stability, comparability, PPQ, method transfer, validation readiness, and commercial readiness activities.Contribute to immunoassay analytical control strategies,...Contract work$170k - $198k
...providing statistical leadership for specification setting and Justification of Specifications (JOS) across late-stage development, PPQ, BLA readiness, and commercial lifecycle management. This individual will collaborate with Process Development, MSAT, Stability, Quality...Remote work$155k - $180k
...editing, viral transduction, cell expansion, formulation).Experience supporting regulatory filings (IND/BLA) and process validation (PPQ).Proven track record of leading complex technical programs and cross-functional initiatives.Strong leadership, mentorship, and cross-...Full timeInternshipLocal area$186k - $200k
...during transfer.Ensure appropriate comparability, validation, and verification strategies are defined and executed.Confirm readiness for PPQ, conformance, and commercial launch from a Quality standpoint.Approve tech transfer-related GMP documentation, including:Tech...Work at officeRemote workWorldwide$127k - $165.5k
...process comparability assessmentsAssist with planning and execution for process characterization and Process Performance Qualification (PPQ) activitiesProvide broad technical support across MSAT initiatives as needed, such as assistance with Statement of Work (SOW) review...Full timeWork experience placementLocal areaRemote workFlexible hours- ...expertise in downstream unit operations and quality‑by‑design principles, along with hands‑on experience supporting late‑phase programs, PPQ readiness, and technology transfer into cGMP manufacturing. This role will provide technical leadership across cross‑functional teams...Full timeLocal area
- ...Process Verification (Stage 3) activities across the site. This role is responsible for ensuring validation protocols, risk assessments, PPQ studies, and CPV programs meet applicable regulatory expectations and internal procedures, while taking direct, hands-on ownership of...Full timeH1bVisa sponsorshipWork visa
$170k - $200k
...vaccine CMC, biologics development, QC, ASAT, or related regulated laboratory environments.Experience supporting late-stage development, PPQ readiness, BLA preparation, commercial readiness, or lifecycle management of vaccine or biologics programs.Experience managing...Contract work$145k - $160k
...filtration, aseptic transfers, filling setup, container closure, visual inspection)Lead or support validation lifecycle activities (PPQ, CPV, monitoring, trending) and manage tech transfer, scale up, site transfer, new product introduction, and lifecycle managementServe...Local areaFlexible hours$165k - $192k
...environments either directly or through CMO partnerships.Preferred experience in late-stage DP development, design and execution of PPQ protocols, and robust, reproducible, regulatory-compliant drug product manufacturing processes. Includes experience conducting risk assessments...$118k - $158k
...engineering runs and Process Improvement Program (PIP) initiatives.Develop critical validation documentation required to support the PPQ program planned for Q2 2027, including PPQ protocols, Process Validation Master Plans, microbial validation documentation, statistical...Full timeTemporary workLocal areaShift work