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- ...And that's the kind of work we want to be part of . Key Responsibilities: • Execute and document validation activities (IQ, OQ, PQ, PPQ), including risk assessments and periodic reviews. • Support the full Validation Life Cycle-from design through revalidation and...Suggested
- ...validation activities with minimal supervision. Key Responsibilities: Execute and manage downstream validation activities (IQ/OQ/PQ, PPQ support). Validate downstream equipment including autoclaves, environmental chambers, chromatography, filtration/UF-DF,...Suggested
Validation & Engineering Group
Puerto Rico16 days ago - ...Issues for Approval SOPs and Manufacturing Procedures Develops and Executes Component Qualifications Develops and Executes PQ and PPQ Protocols and Reports Designs / Coordinates Facilities Modifications Creates / Coordinates Manufacturing Line Layout...Suggested
Validation & Engineering Group
Puerto Rico6 days ago - ...project supporting the transition to the Black Pupae Strain (BPS) of the Mexican fruit flies by the USDA Plant Protection and Quarantine (PPQ) Science and Technology. The project will develop new and standardized operating procedures (SOPs) for closed colony rearing to...SuggestedWeekend work
- ...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....SuggestedTemporary workLocal areaFlexible hoursShift workDay shift
- ...manufacture and disposition products to patients in a timely manner. Lead and oversee manufacturing processes including engineering runs, PPQ and APS. Ensure manufacturing processes in both an R&D and GMP environments are following appropriate protocols and/or standard...SuggestedShift work
- ...Agreements with these vendors Manage external vendors and ensure that tox/GLP material, clinical Phase 1/2 batches, Phase 3 batches, and PPQ/validation lots are delivered on time and on budget Draft and negotiate SOWs for outsourced projects, manage these projects on...Suggested
- ...Document sampling activities and results in compliance with GMP and data integrity (ALCOA+) requirements. Support validation, PPQ, and process verification activities during new product introductions and equipment changes. Participate in deviations, investigations...SuggestedPermanent employmentTemporary workInternshipMonday to FridayShift workWeekend work
$95.2k - $176.8k
...investigations. You have deep expertise in cGMP environments, with a track record of successfully leading Process Performance Qualification (PPQ) and authoring CMC sections for regulatory filings. You thrive in "startup" style environments within a larger organization,...SuggestedLocal areaRemote workRelocation package$61.3k - $122.7k
...engineering problems with processes or equipment already in operation. ~ Generate and execute process validation protocols (IQ/OQ/PQ, PPQ) in alignment with medical device regulatory expectations. ~ Provide manufacturability feedback to R&D on PCB layout, component...SuggestedFull time- ...Convert lab procedures to scalable unit operations (reaction, crystallization, filtration, drying), author/execute transfer packages and PPQ protocols. Continuous Manufacturing: Develop, implement, and optimize continuous processes for small-molecule APIs, ensuring...SuggestedPermanent employmentFull timeContract workFor contractorsTrial period
$48 - $60 per hour
...design control deliverables. Plan and execute design verification and validation activities, including process validation IQ/OQ/PQ/PPQ. Actively participate in core team and customer-facing meetings. Translate user requirements into discrete, objective,...SuggestedContract workTemporary work$195k - $275k
...geographies. CMC & Regulatory Support Co-lead registration stability, process characterization, and Process Performance Qualification (PPQ) activities. Co-author and review CMC sections of regulatory submissions (INDs, IMPDs, NDAs/MAAs), including process descriptions,...Suggested$142.63k - $176.19k
...Specific responsibilities include: Drive statistical strategies for process validation and comparability, including risk-based PPQ approaches and direct interface with FDA/EMA statisticians during regulatory reviews Lead statistically robust study design and analysis...SuggestedContract work$169.7k - $267.2k
...functional biologics drug product (DP) working groups and manages DP activities through filing and Process Performance Qualification (PPQ), including registration stability study execution, process characterization plan and execution, tech transfer control strategy,...SuggestedFull timeFor contractorsWork at officeLocal areaRemote workRelocationVisa sponsorshipFlexible hoursShift work3 days per week- ...company's global manufacturing network. This role ensures that all validation activities—including process performance qualification (PPQ), cleaning validation, and lifecycle monitoring—are scientifically sound, risk-based, and compliant with global regulatory...Remote jobFull timeContract workWork at officeWorldwideRelocation package
- ...Position: The Global Supplier Quality, External QC -Vector will process external deviation and change records from our Contract Test Laboratories (CTL). Other duties may include; coordinate shipping and testing of samples for lot release, PPQ, PSQ and w... Tech DigitalContract work
$245k - $271k
...QA lead for all GMP‑related activities including tech transfer, scale‑up, validation/qualification (facilities/utilities/equipment, PPQ, cleaning), and analytical/method validation & transfer through production and release of clinical materials. Oversee quality oversight...Contract workTemporary workFlexible hours- ...matrices). \n Supervise building and testing functional prototypes to assess feasibility and performance. \n Handle FAT/SAT and PPQ protocols for system qualification and validation, ensuring readiness for audits and regulatory inspections. \n \n Solve &...Local area
Johnson and Johnson
Reading, PA9 days ago - ...and OOS/OOT events using structured root cause analysis Lead and execute process validation activities including IQ, OQ, PQ, and PPQ Ensure compliance with cGMP and global regulatory standards including FDA, EMA, WHO, and ICH Drive continuous improvement...Contract work
$158k - $198k
...standards, and best practices. Collaborate with internal and external stakeholders supporting process validation strategies and oversight of PPQ documentation such as Validation Master Plans (VMP), Criticality Analysis (CA), Risk Assessments (RA), Validation Protocols and...Full timeH1bWork at officeLocal areaRelocationWork visa$101.2k - $124.6k
...review, and execute Validations (Installation Qualification (IQ)), Operational Qualification (OQ), and Process Performance Qualification (PPQ) and Qualifications for equipment, systems, products and processes. Manage multi-departmental projects to ensure that initiatives...Permanent employmentWorldwide$160k - $185k
...manufacturing changes Supports DS Manufacturing Quality by Design (QbD), Process Characterization (PC) and Product Performance Qualification (PPQ) activities for late phase to commercial programs Manages contracts, including negotiations for technology transfer, manufacturing,...Full timeContract work2 days per week$175k
...track progress and implement mitigation actions as appropriate in close collaboration with Quality ensure cGMP Compliance for successful PPQ and timely Regulatory approval. Key requirements : ~ Bachelor’s degree in Life Science, Engineering or Business Management....Full timeTemporary workLocal areaRelocation packageLonza
Vacaville, CA25 days ago- ...including the supporting development studies Lead the cross-functional team through technical activities, development studies and PPQ batches Create technical transfer documents supporting this goal [Technical Transfer Plan, Process Development studies (i.e....Permanent employmentWork at officeShift workNight shift
- ...delivering the following aspects: Budget responsibility for team and related activities Define and own lab experiments Post PPQ, full ownership of all continuous process validation activities Lead and coordinate large-scale technical projects from initiation...Remote jobFull timeWork at office
- ...enable product launch, including transfers both within and outside of AbbVie. 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...Full timeContract workTemporary workLocal areaWorldwide
$217.28k - $266.75k
...Director, Drug Substance Manufacturing is responsible for leading GMP drug substance manufacturing, process performance qualification (PPQ), ensuring commercial supply, and overseeing all CMC activities related to Fab-oligonucleotide conjugates (drug substance). This role...Contract workLocal area- ...and sales experience. Relevant industry credentials such as ISA Certified Arborist and additional qualifications including TRAQ or PPQ. Strong proficiency with technology and the ability to navigate multiple software systems (e.g., Microsoft Office Suite, CRM...Permanent employmentFull timeTemporary workWork experience placementWork at officeLocal area
$103.1k - $154.7k
...yields a robust process. • Collaborate closely with upstream tech transfer MST team and the site Process Validation team to ensure PPQ readiness; co-author PPQ protocols and reports, ensuring GMP compliance. • Serve as the subject matter expert across gene therapy process...Remote jobFull timeContract workTemporary workWork at officeAfternoon shift
