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- ...executes, and directs validation activities for both NPI and existing product lines. Including but not limited to: VMP, IQ, OQ, PQ, PPQ, etc. ~ Maintains and creates documentation including validation protocols, SOPs, test plans, test reports, PFMEA, VMP, quality and...SuggestedLocal areaRemote work
ATL Technology
Maple Grove, MN13 days ago - ...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, Inc
Puerto Rico7 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, Inc
Puerto Rico27 days ago - ...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...SuggestedPermanent employmentFull timeTemporary workWork experience placementWork at officeLocal area
The Davey Tree Expert Company
Columbus, OH29 days ago - ...skills and practices to gather process validation acceptance criteria, process parameter data, and performance indicator data to support PPQ campaigns. Assist with process validation documentation by documentation reviews and data verification of protocols and reports....SuggestedContract work
- ...schedules. HELPFUL CERTIFICATIONS (Preferred) Program Management Professional (PgMP) certification Project Professional Qualification (PPQ) Scrum Master Certification ITIL certification Equivalent Certification outside of the US PREFERRED EXPERIENCE (Not Required)...Suggested
$80k - $115k
...and validation campaigns Collaborate with cross-functional teams to ensure successful execution of process performance qualification (PPQ) and continued process verification (CPV) Prepare technical reports, presentations, and documentation for internal and regulatory use...Suggested$196.7k - $353.4k
...inspection technologies (manual and robotic). Process validation, EMPQ, and media fills. Regulatory compliance and contributions to PPQ and BLA filings. Familiarity with global regulatory guidelines (CFR 21, ICH, PDA standards). Proficiency in Continued Process...SuggestedPermanent employmentFull timeWork experience placementWork at officeRemote workWork from homeWorldwide$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- ...records from our Contract Test Laboratories (CTL). Other duties may include coordinating shipping and testing of samples for lot release, PPQ, PSQ and compiling vendor documentation to generate a CoA/CoT. This role will partner cross-functionally with Global Product Quality,...SuggestedContract workWork at office
- .... 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 continuous...Suggested
$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 spacing...Suggested$130.8k - $209.4k
...our Norwood site, you will lead the execution of Technical Transfer and Process Validation activities, including protocol creation, PPQ execution at internal and external facilities, and report generation. You'll act as the driving force for cross-functional collaboration...SuggestedWork at officeWork from homeWorldwide- ...interested in joining this team, read below to find out more… In your new role, you will: Support NPI QC Testing on PSBs, Clinical, PPQ, Demo and investigational lots via Cell Based Potency Assay and related ELISA methods. Timely review of testing records and all...SuggestedFull timeFixed term contractImmediate start
- ...process characterization. Knowledge of cellular immunology and/or vector manufacturing a plus. Experience with cGMP, ICH guidelines, PPQ (process validation), control strategy development, and working within a Quality organization. Proficiency utilizing MS Office products...SuggestedCasual workShift work
- ...inspection technologies (manual and robotic).* Process validation, EMPQ, and media fills.* Regulatory compliance and contributions to PPQ and BLA filings.* Familiarity with global regulatory guidelines (CFR 21, ICH, PDA standards).* Proficiency in Continued Process...Work experience placement
$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,...Full timeFor contractorsWork at officeLocal areaRemote workRelocationVisa sponsorshipFlexible hoursShift work3 days per week- ...process validation strategy development, including process design, assignment and testing of critical process parameters (CPPs), drafting PPQ (Process Performance Qualification). Minimum Qualifications: Advanced degree (PhD, MSc, or equivalent) in Chemical Engineering,...Full timeContract workTemporary work
- ...requests, creating customer shipment reports, maintaining traceability and assisting with inspections (Final, In-Process, 1st PC, or PPQ). Support FAI and APQP processes by completing inspections, measurements, gage studies and related reports. Support Incoming/Receiving...Permanent employmentFull time
- ...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...Work at officeRemote work
- ...and performance Fully engaged in initiatives across Technical Services functions for the Building Cell (Engineering batches, pre-PPQ demos, PPQs, CCOQs for new equipment, TS studies to drive improvements or generate data for investigations, Sterility Assurance Validations...Contract workTemporary workWork at officeWorldwideFlexible hoursNight shift
Simtra BioPharma Solutions
Bloomington, IN2 days ago - ...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
- ...00 FT US Employees in over 60 world class US Operations. CTDI also has a global footprint with more than 20,000 employees worldwide./ppQ.C. Inspector B is responsible for inspecting and testing products or materials to ensure they meet quality standards and specifications...WorldwideMonday to FridayShift work
- ...monoclonal antibodies, bi-specifics, ADCs, fusion proteins and other molecular formats for early and late-stage clinical assets. Leads PPQ enabling cell culture process characterization activities. Leads/participates in cross-functional CMC teams and reviews relevant...Full timeTemporary workWork experience placementLocal area
- ...customer reports for shipment, maintaining traceability requirements, and assisting with inspections (Final, In-Process, 1st part, or PPQ). Support FAI and APQP processes by completing inspections, measurements, gauge studies, and related reports. Support Incoming/...Permanent employmentFull time
$85k - $101k
...equipment, and documentation are in place to support compliant and efficient manufacturing. Contribute to validation activities (e.g., PPQ campaign, process characterization, etc). Support manufacture data capture for trending and CPV. Perform hands‑on training in...Day shift- ...analytical leadership for post-approval CMC LCM projects, facilitate and manage testing activities in support of process characterization, PPQ, and analytical comparability studies, develop derisk strategies, provide oversight to analytical results for regulatory submissions....Local areaWorldwideFlexible hours
- ...batch and continuous platforms* Demonstrated experience leading drug substance teams through late-stage clinical and process validation (PPQ)* An ability to operate with flexibility as part of a team in a dynamic environment with tight deadlines, engaging other scientists...
- ...validation lifecycle Align global documentation strategy Provide input and review for validation documents including master plans, PPQ and comparability protocols and reports Serve as reviewer/author of a variety CMC sections or regulatory submissions, risk assessments...Temporary workRemote workWorldwideFlexible hours
- ...templates, providing documentation management and oversight and continual enhancements. Manage firm’s Past Performance Questionnaires (PPQ), and/or the firm’s Contractor Performance Assessment Reporting System (CPARS) evaluations, and any other past performance data for...For contractorsWork at office
