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- ...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 areaShift workDay shift
$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- ...subcontractors via phone calls and direct messaging Submitting pre bid RFI, facility access documents, requesting bid bonds, and PPQ's as instructed Attending Site Visits Manage estimate file integrity Support estimating team with their duties as needed...SuggestedFor subcontractorInternshipWork at officeFlexible hours
- ...note integrity. Manage estimate file integrity using Microsoft Sharepoint. Submitting pre bid RFI, facility access documents, and PPQ's as instructed. Bid Bond Management Technical Proposal Coordination and confirmation Final Proposal Submissions...SuggestedFor subcontractorWork at officeRemote work
- ...Identify and address technical gaps between sites to ensure seamless transfer. ? Support engineering runs, scale-up activities, and PPQ/validation batches. ? Provide project oversight through status reporting, issue escalation, change control support, and stakeholder...SuggestedWork at officeShift workWeekend work
Validation & Engineering Group, Inc
Puerto Rico2 days ago - ...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... Omni InclusiveSuggestedContract work
- ...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 Rico27 days ago - ...Writes documentation for internal and external use, such as manufacturing campaigns summary reports, process performance qualification (PPQ) protocol and reports, impact assessments etc. Leads training of manufacturing staff and process sciences group on new processes,...SuggestedFull timeWork 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,...SuggestedFull timeFor contractorsWork at officeLocal areaRemote workRelocationVisa sponsorshipFlexible hoursShift work3 days per week- ...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
$66k - $99k
...to participate in Manufacturing Sciences and Technology activities in support of downstream technology transfer, late stage clinical, PPQ and commercial manufacturing of viral vectors. The individual will serve as a process expert in downstream processing. This position...SuggestedRemote jobFull timeTemporary work$95 - $104.96 per hour
...external partners. Drive Validation Excellence: Lead and support comprehensive process validation activities, including IQ/OQ/PQ/PPQ and Test Method Validation (TMV), to ensure robust manufacturing processes. Oversee Design Controls: Own and manage Change Plans...SuggestedHourly payContract workTemporary workWork experience placement$78k - $156k
...installation qualifications (IQ), operational qualifications (OQ), performance qualifications (PQ), and process performance qualifications (PPQ). ~ Provide technical mentorship and direction for junior engineers and ensure timely delivery of program milestones. ~...SuggestedFull timeWorldwide$111k - $159k
...architecture drafting experience (NAF, TOGAF, or equivalent). Expert-level programme/project management certification (e.g., PMP, MSP, PPQ). Valid NATO nation passport with no travel restrictions to NATO nations. Citizen of a NATO member nation; active NATO or...SuggestedFull timeContract workFor contractors- ...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...SuggestedFull timeTemporary workWork experience placementLocal area
- ...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, IN23 days ago $130.8k - $209.4k
...experience (e.g China and/or global partners) is advantageous Strong background in biologics CMC principles including ICH Q6b standards, PPQ/BLA readiness, analytical control strategies, and specification setting Experience developing characterization methods for...Hourly payWorldwide- ...validation master plans for process and cleaning validation. Lead the design, planning, and implementation of validation protocols (PPQ), including risk assessments and data analysis during tech transfer. Oversee the review and approval of validation documentation,...Permanent employmentFull time
$143k - $155k
...project timelines, identify risks, and escalate issues to Tech ops and CMC as needed. Design and support characterization studies and PPQ protocols for late-stage programs Support IND and BLA development for our most advance program What’s in it for you: Joining...Full timeWork at officeVisa sponsorshipWork visa- ...parenteral DP from development scale up to clinical/commercial scale. Support drug product manufacture at GMP facilities from clinical to PPQ and commercial batches. Understand relevant scientific literature and apply theoretical framework to solving problems within...Full timeTemporary workLocal area
$158k - $198k
...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 Reports...Full timeLocal area- ...work instructions, job aids, line layouts, routings/BOMs, and training materials. Own transfer readiness: plan engineering/pilot/PPQ builds, execute line trials, support ramp, and drive disciplined change control to closure. Lead investigations and disposition of...Full timeContract work
- ...manufacturing capabilities at the site and within the DPS network, including equipment, filling line and facility qualification as well as PPQ support for BLA projects. Manage complex deviations and complaints using scientific and statistical insights to analyze data,...Local areaRelocation package
Lonza
Indiana, PA21 hours ago - ...gases, HVAC) Equipment (formulation vessels, autoclaves, washers, filling lines, Isolators, and RABs) Process validation (PQ, PPQ, CPV) Cleaning validation Computerized systems validation (CSV / CSA) ~ Ensure compliance with Annex 1, FDA guidance, and...
Nivagen Pharmaceuticals Inc
Sacramento, CA4 days ago - .... Author process validation protocols and reports. Including but not limited to equipment IQ, process OQ, process PQ, and product PPQ. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures...For contractorsInternshipLocal areaImmediate startRelocationFlexible hoursShift workDay shiftAfternoon shiftEarly shift
- ...selection, and oversight of CDMOs for drug product manufacturing. Ensure successful tech transfers, manufacturing readiness, and PPQ strategy development in collaboration with Manufacturing and Quality. Apply Quality by Design (QbD) principles to develop and optimize...
- ...supplier of finished medical devices and/or a Private Label manufacturer. This role supports product development through validation, PPQ, and sustained manufacturing operations. The ideal candidate is hands-on, decisive, and comfortable operating across Engineering, Manufacturing...Full time
$190k - $257k
...development of robust and scalable drug product formulations and manufacturing processes. The role will focus on Late Stage program, PPQ, commercialization readiness, and life-cycle management activities. This individual will manage drug product-related activities with...Structure Therapeutics
South San Francisco, CA13 hours ago- ...investigate any project challenges with necessary risk assessment tools and techniques, as needed. Supports best practices for TT and PPQ strategies globally, as required. Coordinates and supports QCAD Bioassay lab activities and provide training for QC Bioassay lab...Full timeContract work
- ...Hire) Location: San Diego, CA (On-Site) Contract: 6 Months (Contract-to-Hire) Key Responsibilities Develop and execute PPQ protocols for automated CGT manufacturing equipment Support Computer Systems Validation (CSV) activities Assist with MES...Full timeContract workImmediate start
Intellectt Inc
San Diego, CA1 day ago
