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$95.3k - $116.6k
A pharmaceutical company in Milford, Massachusetts is seeking a Senior QA Specialist to provide quality guidance for client manufacturing programs. The role requires interfacing with clients in the late stages of product development, ensuring compliance with cGMP regulations...Suggested- A global staffing firm is seeking a Project Administrator III to provide operational, project coordination, and administrative support for the HRIX Project Process & Quality team. Responsibilities include managing project intake, coordinating events and facilities, as well...SuggestedContract work
- A biotechnology company is seeking a Senior Validation Engineer to develop and execute validation strategies within a GMP environment. The successful candidate will need a Bachelor's in Engineering and over 5 years of experience in biopharma validation and process engineering...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
- 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
- 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
$95.3k - $116.6k
...stages of development and/or commercialized. This includes interfacing with clients that are nearing process performance qualification (PPQ), PAI and commercial readiness, and that are approved to manufacture in global regions. Key Responsibilities: Provide leadership to...SuggestedFull timeWork experience placement- ...and sampling plans; ensure launch readiness and timeline adherence. Validation & Lifecycle Management: Lead validation lifecycle: PPQ strategy/execution, cleaning validation, lyophilize cycle development, and continued process verification (CPV). Sponsor risk assessments...SuggestedWork at office
WuXi AppTec
Middletown, DE6 days ago - ...compliance. Support technology transfer activities, including process scale-up and validation. Lead and execute process validation (PPQ), including protocol development, data analysis, and report generation. Monitor process performance through data analysis and...SuggestedFull timeWork at office
LEGAL PROJECT MANAGEMENT PARTNERS LLC
Puerto Rico9 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....Suggested
- ...projects (with a primary focus on quality and efficiency indicators) and communicate with R&D management team. Technology Transfer (PPQ Projects) Manage the technology transfer process of PPQ projects from R&D to production. Guide department employees in leading...SuggestedWork experience placementWork at office
WuXi AppTec
Middletown, DE6 days ago - ...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
- ...providing hands-on support for manufacturing processes and quality systems (FDA QSR, ISO 13485) Drive validation success through IQ/OQ/PQ/PPQ activities, Test Method Validations, and rigorous Process Characterization Lead continuous improvement initiatives to enhance...Suggested
$22 - $26 per hour
...Dispense non‑controlled pharmaceuticals (Requires Veterinary Medical Clerk License) Removal of exposed foreign bodies (i.e., Ticks or PPQ’s) (direct DVM/LVT supervision) Perform ECG & blood pressure readings (direct DVM/LVT supervision) Set up for all surgery types...SuggestedFull timeLocal areaImmediate startFlexible hours- ...experience, and relevant knowledge. What you will do: Review and approve engineering and validation documentation, including IQ/OQ/PQ/PPQ protocols, master plans, risk assessments, and periodic reviews. Partner with internal and external engineering teams to support new...SuggestedTemporary 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...
- ...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.**...Temporary workLocal areaFlexible hoursShift workDay shift
- ...Develop and execute validation protocols and reports in compliance with cGMP requirements. Support process performance qualification (PPQ) and validation lifecycle activities. Collaborate with Manufacturing, Quality, and Engineering teams to ensure successful...Weekend work
Validation & Engineering Group, Inc
Puerto Rico3 days ago $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...- ...developing training modules and appropriately illustrated identification aids and works with national program staff to deliver training to PPQ, DHS and State employees. Exercises agency regulatory authority by initiating regulatory action, e.g. for quarantine pests...Local areaShift workWeekend work
$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- ...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 scientific...Temporary workLocal area
- ...Manufacturing, Science, and Technology (MSAT) for control strategy updates and CPV enhancements; enable Product Process Qualification (PPQ) readiness where applicable. Lead continuous improvement projects impacting yield, RFT, and cycle time. Co-lead audit front-...
- ...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
- ...Lead execution of tech transfer activities for internal pipeline and CDMO partners into GMP Execute process demonstration runs (PDRs), PPQ batches in alignment with approved protocols Collaborate cross‑functionally to ensure processes are scalable, robust, and suitable...
- ...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
- ...Administrator III provides advanced operational, project coordination, and administrative support for the HRIX Project Process & Quality (PPQ) team. This role ensures smooth execution of project intake, tooling, facilities coordination, vendor management, and day‑to‑day...Contract workWork at officeShift work
- ...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...Full timeTemporary work
- ...user requirements and regulatory requirements are met and the equipment produces products of the desired quality. Perform IQ, OQ, PQ & PPQ on new or existing automated lines. Perform test method validation such as burst and peel tests. Execute equipment commissioning...Local area
- ...Instrumentation Packaging and Labeling Equipment, Serialization FDA’s current expectations related to PV/Process Performance Qualification (PPQ) Other Requirements Physical Demands The physical demands described here are representative of those that must be met by an employee...Work experience placementWork at office
