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- ...viral vector manufacturing. This individual will provide hands-on technical leadership across internal and external sites, focusing on PPQ readiness and regulatory submissions. The role requires independent authorship of CMC content for BLAs/MAAs and close collaboration...Suggested
- ...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
$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$108.08k - $148.61k
...personnel, materials, and manufacturing suites are prepared for scheduled operations.Support technology transfer, process implementation, PPQ, clinical manufacturing, and commercial manufacturing activities.Monitor production performance, equipment availability, schedule...SuggestedFull timeContract workShift work$187.5k - $200k
...Ocular Therapeutix products. This role has primary responsibility for Process Validation, including Process Performance Qualification (PPQ), Continued Process Verification (CPV), Cold Chain Shipping Validation, and Packaging Validation, while providing broader validation...SuggestedWork at officeLocal area- ...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
$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- ...independent study execution within a GMP manufacturing environment. Focus On exp: Experience with KNEAT trade off systems exp would be ValGenesis, cleaning validation, SIP/CIP, thermal validation, biologics manufacturing, PPQ/CPV, Minitab, or facility startup projects.SuggestedFull time
- ...qualification, oligonucleotide technology transfer, implementation/optimization of enterprise systems, successful execution of Drug Substance PPQ batches all the way through commercial production and launch. The successful candidate will build and manage multiple shifts for...SuggestedFull timeContract workTemporary workFor contractorsLocal areaFlexible hoursShift work
$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- ...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
- ...related to analytical control and product quality.Lead the design and execution of late-stage method validation strategies (Phase 3/PPQ readiness) to ensure methods are commercially viable and robust.Oversee forced degradation studies and stability-indicating method development...SuggestedContract workLocal areaWorldwideFlexible hours
- ...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
$135.46k - $203.19k
...external audits and supporting or hosting health authority inspections with successful outcomes.Experience in technology transfers, PPQ, method transfers, cleaning/process validation, and control strategy implementation.Proficiency in risk assessment tools and using data...SuggestedFull timeContract workTemporary work$141.57k - $194.65k
...Operations.What you will doEnsure adequate technical support for clinical and commercial products through Process Performance Qualification (PPQ), technology transfer, process monitoring, troubleshooting, product stewardship, validation support, manufacturing readiness,...SuggestedLocal area$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.•...For contractorsLocal areaShift work$65k - $80k
...engineers, and operators to realize high quality, stable processes. Provide data and documentation for product process qualifications (PPQ), work instructions and manufacturing quality control plans. Inspection Collaborate with manufacturing engineers and quality to...Quest Global
Winston Salem, NC7 days ago- ...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...
- ...history as requiredDevelop and execute equipment qualification/validation documentation and activities as applicable (e.g., DQ/IQ/OQ/PQ, PPQ where required).Sustain and improve existing tooling/equipment: troubleshoot issues, implement upgrades, optimize performance (uptime...Local areaWorldwideFlexible hours
$169.32k - $219.12k
...all supporting documentation/reports toward BLA submission, provide support to ensure successful process performance qualifications (PPQ), and author relevant sections of BLA.Lead and/or support technology transfer and investigation activities in partnership with the global...Full timeFor contractorsLocal areaFlexible hours$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- ...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
- ...batch records Draft change control proposals and deviation impact assessments Draft process validation protocols and reports including PPQ protocol, process justification reports, process validation master plan Interpret results and draw conclusions from own multistage...Temporary work
$103k - $133.75k
...development, and technology transfer.Provide technical support during GMP manufacturing campaigns, engineering runs, process validation, and PPQ activities.Execute studies supporting formulation and process optimization, product and process characterization, and manufacturing...Full timeTemporary workLocal area$157.74k - $213.41k
...and deep product attribute knowledge to shape analytical control strategies and enable successful process performance qualification (PPQ), regulatory submissions, marketing authorization, and commercial launch. In close collaboration with Process Development, Manufacturing...Full timeContract workFlexible hours$86.8k - $130.2k
...budgetDrive continuous improvement activities and operational excellence, including COGS reduction and commercial readiness.Support pre-PPQ and PPQ activities.Establish robust process performance across all clinical and commercial manufacturing lines, including process...Full timeTemporary workSummer workFlexible hours- ...generate development/ registration QbD reports and ensure robust documentation of development history/data prior to process validation/ PPQ.Collaborate with Drug Regulatory Affairs (DRA) at 3rd Party/ CMO and Hikma to author/ or review documentation required for product...Full timeWorldwide
- ...industry standards, and regulatory requirements. Provide Quality oversight of validation lifecycle activities, including process validation/PPQ, cleaning validation, equipment and facility qualification, and other GMP validation activities. Review and approve validation...Contract workWorldwide
$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...Full timeWork at officeLocal areaWorldwide- ...the transfer of commercially approved sterile injectable products and possess strong expertise in aseptic manufacturing, validation, PPQ execution, and cross-functional project leadership. Key Responsibilities Independently manage multiple sterile injectable technical transfer...Contract work
