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- Kindeva Drug Delivery is seeking a Process Validation Engineer to support PPQ, CPV, and technology transfer within our MS&T group. You will collaborate across Manufacturing, Quality, Process Development, and Regulatory Affairs to ensure robust, compliant, and scalable manufacturing...Suggested
- ...Medicines seeks a Senior Manager, Quality Validation to lead QA oversight of validation for external manufacturing networks, focusing on PPQ and CPV across Drug Substance, Drug Product, and packaging processes. You will review validation documentation, manage lifecycle...Suggested
$85k - $132.65k
...Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Process Performance Qualification (PPQ), cleaning validation, change control assessments, and validation-related deviations.Ensure validation documentation is accurate, complete...SuggestedFull time- ...well as customer audits, surveys and assessments as needed.Document control and repository key user (EtQ).Support Process Leader and PPQ Leader on management reviews, major quality initiatives and process improvements.Assess and resolve process deviations that lead to decreased...SuggestedWork at officeLocal areaImmediate startFlexible hours
- ...Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Product Performance Qualification (PPQ) Responsible for process development, equipment specification, acquisition and implementation. Understands engineering principles theories...SuggestedFor contractors
- ...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
$129k - $156k
...execute commissioning, qualification, and validation activities for process equipment and systems, including support of FATs, SATs, and PPQ.• Partner with Quality Assurance to ensure alignment with Quality Systems, data integrity requirements, and regulatory commitments.•...SuggestedFor contractorsLocal areaShift work$193.1k - $289.7k
...optimization, and control strategy developmentDevelop and implement statistical approaches supporting Process Performance Qualification (PPQ), Continued Process Verification (CPV), Statistical Process Control (SPC), and process capability monitoringSupport analytical method...SuggestedFull timeSummer workRemote workFlexible hours2 days per week- ...enable product launch, including transfers both within and outside of organization. Lead/support process validation activities (IQ/OQ/PQ/PPQ), including TMV. Mentor/lead product team members through the design transfer process providing guidance to assure optimal approach....SuggestedContract workLocal 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- ...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
- ...GMP and 21 CFR Part 11 standards Develop and execute Master Validation Plans, SOPs, and validation protocols for process validation (PPQ), aseptic processes, and cleaning/sterilization procedures Conduct equipment qualification activities (IQ/OQ/PQ) and ongoing performance...Suggested
$164k - $205k
...external commercial manufacturing network. The role will have primary responsibility for QA oversight of Process Performance Qualification (PPQ) and Continued Process Verification (CPV), as well as other validation activities supporting commercial manufacturing, packaging, and...SuggestedFull timeWork at officeLocal areaWorldwide$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
- ...Responsibilities: Quality Review & Documentation Oversight: Review and approve engineering and validation documentation including IQ, OQ, PQ, PPQ, Validation Master Plans, risk assessments, calibration records, and periodic reviews. Create, review, and approve SOPs, Change...
$121.9k - $195k
...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- ...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...Local areaWorldwide
- ...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....Full timeTemporary workLocal areaFlexible hoursShift workDay shift
$173.2k - $272.6k
...antibody formats.· Experience with late-stage process characterization, viral clearance studies, process performance qualification (PPQ), and validation.· Experience authoring regulatory submission content (e.g., BLA sections) and/or working with external development or...Full timeContract workFor contractorsLocal 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...Contract work$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...Work at office- ...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...Local areaWorldwideFlexible hoursShift work
- ...fit), metals joining (e.g. laser welding, riveting, swaging, crimping), and general assemblyDevelop, document, and qualify (IQ/OQ/PQ/PPQ) new manufacturing and test processes using statistical tools such as Design of Experiments (DOE), Process Capability (Cpk), and Test...Local areaWorldwideFlexible hours
$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- ...end-to-end delivery of NPI programs spanning tech transfer, process development, engineering runs, training runs, process validation (PPQ), and commercial handoff, coordinating across Manufacturing, Quality, Engineering, and Supply Chain.Compile and maintain integrated...Full timeContract workFor contractors
- ...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...Local areaWorldwideFlexible hours
$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,...Full timeTemporary work$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...$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 timeLocal areaRemote workFlexible hours