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- A leading aluminum manufacturer seeks a Process & Product Quality Technician in Lewisport, KY. This role involves overseeing and improving processes to ensure high product quality standards. The ideal candidate will handle quality support operations, conduct daily checks...SuggestedFull timeShift work
- Process & Product Quality (PPQ) Technician - ABS Job Category : Tech - RD - Engineering Requisition Number : PROCE001526 Apply now Posted : March 3, 2026 Full-Time Locations Showing 1 location Lewisport, KY 423510480, USA Description Commonwealth Rolled Products...SuggestedFull timeTemporary workWork at officeImmediate startRotating shift
- Overview Job Title: Engineer - Biologics Drug Substance PPQ support (JP14922) Location: Holly Springs, NC 27540 Employment Type: Contract Business Unit: ANC PD Site Lead Duration: 1+ year with likely extensions and/or conversion to permanent Posting Date: 1/22/2026 Pay...SuggestedPermanent employmentContract work
- A pharmaceutical company based in Bridgeton, Missouri is seeking a Product Process Validation Manager to lead the process validation strategy and execution across the product lifecycle. This key role involves ensuring compliance with regulatory expectations, developing ...Suggested
- A consulting firm in biotechnology is seeking an Engineer for biologics drug substance process validation support. This role involves assisting senior staff with project initiation, design, and delivery, particularly in the area of process validation. Candidates should ...SuggestedContract work
$130k - $185k
A clinical-stage biotechnology company in Boston is seeking a (Sr.) Process Engineer for downstream manufacturing. The role involves leading tech transfer processes, executing engineering runs, and acting as the Person-in-Plant during GMP operations. Ideal candidates should...Suggested- ...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....Suggested
- .../RABS systems Clean utilities (WFI, clean steam, compressed gases) HVAC and classified cleanroom environments Process validation (PPQ) and cleaning validation Data integrity and lifecycle validation governance Why This Role Is Critical The site is undergoing operational...SuggestedContract work
- ...CAPA development Provide technical guidance and oversight to Operations and Validation teams during Process Performance Qualification (PPQ) and Continued Process Verification (CPV) Collaborate cross-functionally to assess, implement, and support new technologies within...Suggested
- ...Huntsville, AL 35806. No third party staffing firms please Description The Proposal Manager will co-ordinate and produce the proposal (RFI, PPQ, ITT, RFP etc.) response whilst assembling a proposal team that has the skills to prepare and submit winning proposals. They will...SuggestedContract workFor contractorsLocal area
- ...Continued Process Verification (CPV). Serve as technical lead for Technology Transfers and strategy for process performance qualifications (PPQ). Present, defend and support change controls and investigations during regulatory inspections. Onboard and troubleshoot equipment....Suggested
$94k - $129.25k
...functional alignment across PD, Analytical, QC, QA, MSAT, Supply Chain, and Manufacturing. Support late‑stage program activities including PPQ readiness, regulatory submissions (e.g., BLA), and commercialization efforts. Apply knowledge of biologics development, including...SuggestedFull timeContract workWorldwide- ...Soliciting 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 Skills,...SuggestedFor subcontractorInternshipWork at officeFlexible hours
- ...Editor provides advanced, independent editorial and technical expertise in support of a cooperative agreement between CIPM and USDA‑APHIS PPQ Science & Technology (Plant Pest Risk Analysis unit). The position supports the development of high‑impact scientific and regulatory...SuggestedFull timePart timeWork at office
- ...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.**...SuggestedTemporary workLocal areaFlexible hoursShift workDay shift
$34 - $38.5 per hour
...programs. Shift: Monday-Friday, 8:00am-5:00pm Pay: $34-$38.50/hour Responsibilities Execute and document process validation activities (PPQ, IQ/OQ/PQ) for equipment, processes, cleaning, and utilities. Write validation protocols and reports for customers in support of...Full timeMonday to FridayShift work$40 per hour
...Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), & Process Performance Qualification (PPQ); validation master plans, risk assessments, calibration and periodic reviews, etc. Participate with plant & external engineering...Contract workLocal area- ...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...For subcontractorWork at officeRemote 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...
- ...requirements is expected. Keywords: Manufacturing Technical Support (MTS), Manufacturing Sciences & Technology (MS&T/MSAT), process validation, PPQ, technology transfer, facility fit, scale-up, process development, bioprocessing Qualifications Prior experience (Ph. D.: 0 - 2 years...Contract work
- ...functional teams.* Support Quality and Production for timely root cause analysis and corrective action implementations.* Oversee IQ/OQ/PQ/PPQ execution and documentation for new and existing production equipment and product design changes.* Identify, justify, and implement...InternshipWork at office
$90k - $95k
...internal standards. Support audits and implement corrective actions. Drive process validation including characterization studies and PPQ. Maintain strong documentation standards supporting data integrity. Your profile Education & Experience Bachelor’s degree in...Contract workWork at office- ...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...For contractorsLocal area
- ...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,...Work experience placement
- ...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...Casual workShift 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,...Contract workWork at office
- ...expansion projects and new stand-up facility. Own development and oversight of URS, FS, DS, FAT/SAT, commissioning, qualification, and PPQ support. Drive seamless integration from equipment procurement through validated commercial launch. Provide technical oversight...Local areaWorldwide
- ...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...Flexible hoursShift work
Cellares
Bridgewater, NJa month ago - ...System Regulation, especially 21 CFR 820.70 for equipment qualification and 21 CFR 820.75 for process validation (FAT, SAT, IOQ, OQ, PQ, PPQ) Must be able to work effectively on electrical, mechanical, and/or software related issues associated with equipment Strong...Shift work
$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...Work at officeWork from homeWorldwide
