Deviation & CAPA Engineer — GMP Manufacturing
TALENT Software Services
TALENT Software Services is looking for a skilled professional to support quality and compliance efforts in Lansdale, United States. The candidate will manage deviations, update key documentation, and lead projects aimed at improving efficiency and compliance. Qualifications include a B.S. or B.A. in Engineering or Sciences, strong technical writing skills, and experience in a manufacturing environment. This position may require collaboration with various teams to meet operational objectives. #J-18808-Ljbffr TALENT Software Services
- ...Reporting to the Senior Manager, Facilities, Engineering and Validation, the Senior Validation... ...Engineering disciplines in a GMP environment. You will be involved in supporting... ...and implementation of change controls, deviations, CAPAs, and regulatory filings. • Draft,...SuggestedFull time
- ...Requirements B.S. or B.A. in Engineering, Sciences, or related... ...Experience and Skills Deviation Management... ...vaccine, or bulk sterile manufacturing facilities, Change Control... ...documents and other GMP documentation Supports... ...Preventative Actions (CAPAs); projects aimed at improving...Suggested
- The Process Engineer III will be heavily involved in managing the manufacturing and production systems for Viral Vector, Testing, and Technical Development... ...support for assigned SOP changes, Deviations, GMP Investigations and CAPAs On-call support as needed for active...SuggestedFor contractorsWork experience placement
- EMS Validation Engineering Lead Job Description What will... ...aligns with GMP, ISO 13485, 21 CFR Part... ...Investigate and resolve deviations, discrepancies, and non... ...and preventive actions (CAPAs). Apply GAMP 5 principles... ...degree in Pharmaceutical Manufacturing, Engineering, Science,...SuggestedWork at officeRemote work
$80k - $100k
...Manufacturing Quality Engineer – Lansdale, PA – $80K–$100K + Benefits A well-established industrial equipment manufacturer in the Quakertown / Upper... ...manufacturing ISO9001 experience required QMS, 8D, CAPA, inspection, supplier quality, and root‑cause experience preferred...SuggestedLocal area- ..., Test Methods, Change Controls, and CAPA/Nonconformance Reporting. Provides... ...Development, and Product/Process Development, Manufacturing and Quality Engineering groups. Assist Validation Manager... ...Management System (QMS) (e.g., FDA GMP Part 820 and/or ISO 13485) preferred....
$75k - $90k
...Job Description Process Control Engineer Hatfield, PA | On-Site | Direct Hire | Full-Time... ...The Opportunity An established industrial manufacturer is looking for a Process Control... ...lead root cause investigations using 8D, CAPA, 5 Why, or similar methods Ability to read...Full timeLocal areaMonday to FridayFlexible hours- ...International is seeking an Automation Engineer located in King of Prussia, Pennsylvania. This role involves supporting various manufacturing and analytical testing systems, ensuring... ...is required along with experience in a GMP manufacturing environment. #J-18808-Ljbffr...
- ...seeking a Sr Lab System Support Engineer. Role Sr Lab System... ...ensure compliance with GLP, GMP, GxP, and data integrity standards... ...Practices (GLP), Good Manufacturing Practices (GMP), and FDA... ...etc.). Knowledge of Problem/Deviation/Change/CAPA Management Process. Education...
- ...Summary Sr Lab System Support Engineer plays a key role in... ...Ensure compliance with GLP GMP GxP and data integrity standards... ...Good Knowledge on the Problem/Deviation/Change/CAPA Management Process. Job... ...Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and FDA...
- Germer International is looking for a Process Engineer III in King of Prussia, PA. The role involves managing manufacturing systems for Viral Vector operations and collaborating with various teams to ensure compliance with quality standards. The ideal candidate will have...
$117k - $184.2k
MSD Malaysia is seeking a professional to support GMP manufacturing of bulk biologic clinical supplies in West Point, Pennsylvania. The ideal candidate will have a degree in Engineering or Sciences and 5+ years of experience, demonstrating strong problem-solving skills...- ...The resource will support automation initiatives within a GMP-regulated biologics pilot plant. This role involves hands-on automation system support, integration, maintenance, and continuous improvement efforts. The individual will also contribute to documentation aligned...
- ...Automation Engineer West Point, PA, United States About the Job Automation Engineer... ...protocols. Generate, review, and approve GMP Lifecycle Documents (e.g., risk... .... ~ Experience with Biopharmaceutical manufacturing, design or/and construction. ~ Knowledge...Contract work
- Lockheed Martin is hiring a Project Engineer in King of Prussia, PA, to support the Reentry Operations Center. The role emphasizes manufacturing integration and technical execution in a fast-paced environment, requiring close cooperation with cross-functional teams. Ideal...
$52 per hour
JSG is recruiting for an Engineer - II (Associate) in Lansdale PA We’re looking... ...Engineer - II (Associate) who has authored Deviation Reports in a Manufacturing environment. In this pivotal role,... ...deviations, investigations, and GMP documentation such as SOPs and batch...Weekly payTemporary work- Merck in West Point, PA is seeking a talented Research Scientist to join their Vaccines and Advanced Biotechnologies Process R&D team. You will be responsible for upstream process development of vaccine candidates and optimizing lab-scale processes. The ideal candidate ...
- Brief Job Description The Process Engineer role focuses on the following accountabilities: Troubleshooting and Problem-Solving - Ability to identify and resolve process-related issues effectively. Reliability - Tracking and improving downtime for process areas. Capital...
$60.12k - $88.17k
Engineering Technical Writer - Manufacturing & Assembly Location: US - PA - Horsham Requisition ID: 19849 About Veeco You probably don’t realize it, but what we do at Veeco touches the lives of every person, every day. It’s a bold statement, but it’s true. From the smartphones...Work experience placementFlexible hours- Germer International is seeking a Process Engineer II to manage manufacturing and production systems for Viral Vector and Technical Development operations. This role involves requirements gathering, process improvement, and technical expertise in facility and equipment...
- A growing technology company is seeking a Technical Support Engineer based in Horsham, PA. The role involves troubleshooting, supporting customers with the AVEVA software suite, and requires 3-5 years of experience in a technical support role. Benefits include medical...
- Barry-Wehmiller Companies Inc. seeks a Project Engineer in King of Prussia to join a skilled team delivering solutions in sectors such as manufacturing and distribution. Responsibilities include planning, project management, and fostering client relationships. Ideal candidates...
$72.68k - $102.6k
...currently recruiting for a: Process Engineer What we do At Kenvue, we realize the... ..., qualification and validation of manufacturing equipment, processes, and systems.... ...reports, and Cor-rective/Preventive Actions (CAPAs)). Contribute to the Long-Range Financial...Work at office$80k - $100k
Mohr Talent is seeking a Manufacturing Quality Engineer for its established client in Lansdale, PA. The role involves maintaining ISO 9001 standards, conducting quality inspections, and improving manufacturing processes. Candidates should have at least 4 years of experience...- ...and Nursing. Job Description This project involves performing engineering modifications and CSV validation on an automated control... ...System Validation (CSV) protocols, writing and resolving protocol deviations, and preparing test summary reports. Prior experience with...
- ...ensure product and process compliance according to established standards. Applicants should have at least three years of quality engineering experience and a high school diploma or vocational training, with preferred qualifications in ISO9001 and AS9100 systems. The position...
- ...Avo Photonics ( is a dynamic contract engineering services company that designs, develops and manufactures custom opto-electronic products for a large customer base. Members of our staff have the opportunity to design, prototype and produce next generation products for...Contract work
- TechDigital Group is seeking an Engineer based in West Point, Pennsylvania, to work on Automotive Systems Engineering. You will handle responsibilities such as functional partitioning of features and developing interfaces between classes while adopting model-based system...
- Allparts, Inc. is seeking a Senior Packaging Engineer responsible for designing and implementing packaging solutions for automotive... ...processes. A technical degree and a minimum of 6 years experience in a manufacturing environment are required. #J-18808-Ljbffr Allparts, Inc.
- ...interfaces between allocable classes Specifying system level requirements and ECU software requirements Adopting model-based system engineering method for specification development. Using Requirement Management tools for requirement authoring, change management and...
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