Pharma Lab Validation Engineer - cGMP & 21 CFR 11
Integrated Resources Inc.
Integrated Resources, Inc. is seeking a Quality Control Validation Specialist in Durham, NC. The ideal candidate must have expertise in validating laboratory instruments in a pharmaceutical setting, with a thorough understanding of FDA regulations and cGMP standards. This role involves developing validation documents, ensuring compliance, and leading risk assessments. Candidates should possess at least four years of relevant experience and demonstrate strong attention to detail in compliance with regulatory requirements. #J-18808-Ljbffr Integrated Resources Inc.
- ...Validation Engineer IRI believes in commitment, integrity, and strategic... ...will consider other FDA -- cGMP experience and medical device... ...installed and configured in a 21 CFR Part 11/Annex 11 compliant manner.... ...systems preferred. · Ensures lab instrument's adherence to...Suggested
- ...given to candidates with FDA -- cGMP experience or in medical... ...combination product production. · Validated Quality Control laboratory... ...configured in compliance with 21 CFR Part 11/Annex 11 . · Provide... ...software in Quality Control labs. · Develop validation documents...Suggested
$98.7k - $183.3k
...Step into a role where your expertise directly enables life‑changing therapies to reach patients safely and efficiently. As a Validation Engineer III, you will play a critical role in bringing manufacturing systems to life—leading validation efforts that ensure...SuggestedRelocation package- Accentuate Staffing is seeking a Cleaning Validation Engineer for a pharmaceutical organization in Morrisville, NC. This role focuses on ensuring compliance through cleaning validation activities and requires strong experience in GMP environments. The ideal candidate will...SuggestedContract work
- Validation Area Specialist (Durham, NC) About the Department For more than 100 years, Novo... ...) Qualifications Bachelor's degree in engineering or related technical field or equivalent... ...computer validation) preferred Experience in cGMP documentation practices & regulations...SuggestedWork at officeLocal area
- Novo Nordisk based in Durham, NC is looking for an IT Compliance Specialist to ensure adherence to IT-related policies and programs. This role involves serving as the primary contact for IT compliance, supporting quality initiatives, and managing IT-related projects within...
$108.5k - $201.5k
...Senior Automation Engineer The Senior Automation Engineer reports to the AD Process Automation... ...procedures to meet GMP requirements, CFR's and internal company policies.... ...knowledge of FDA regulations particularly 21 CFR part 11 and GMP systems. ~ Strong project management...For contractorsWork experience placementRelocation package$108.5k - $201.5k
...Summary The Senior Automation Engineer reports to the Site ITOT Head... ...to meet GMP requirements, CFR's and internal company... ...and execution of system level validation testing including providing guidance... ...FDA regulations particularly 21 CFR part 11 and GMP systems. ~ Applied...For contractorsWork experience placementLocal areaRelocation package- Encodedgenomics is seeking a Manufacturing Engineer to join their team in Morrisville, North Carolina. This full-time role will focus on... ...Ideal candidates should have at least two years of experience in a cGMP setting. Core responsibilities include batch production...Full time
- Encoded Therapeutics Inc. is hiring a Manufacturing Engineer in Morrisville, North Carolina. This role involves executing critical production runs in both cGMP and non-cGMP Gene Therapy campaigns, contributing across multiple business facets. Candidates should have industry...
- ...organization in the Raleigh, NC area who is hiring for a Cleaning Validation Engineer. This is a contract-to-hire or C2C opportunity offering... ...manufacturing environments Strong understanding of FDA, EU, and global cGMP regulatory requirements Experience developing validation...Contract work
$98.7k - $183.3k
Novartis Farmacéutica is seeking a Validation Engineer III in Durham, NC to lead validation efforts for manufacturing systems. This onsite role demands expertise in GMP standards and significant experience in the pharmaceutical field. The Validation Engineer will oversee...- ...identify software defects in electrified and internal combustion engine (ICE) powertrains, ensuring the delivery of robust, high-... ...learning and problem-solving. This role is responsible for the validation of production powertrain control modules, including hardware, software...Full timeImmediate start
- ...Job Description Job Description Title: Facilities and Validation Engineer Job Type: Full-time Location: Durham, NC 27703 Summary... ...in compliance with applicable regulatory requirements (e.g., cGMP, FDA), and support regulatory inspections and customer audits...Full timeFor contractorsWork at office
$136k - $218.5k
...We are now looking for a Senior Verification Engineer for our Memory Management Unit. NVIDIA is seeking outstanding ASIC Verification Engineer to verify the world’s leading GPUs. This position offers the opportunity to have a real impact in a dynamic, technology-focused...- A leading engineering firm is seeking a Sr. Project Engineer to support CAPEX projects in pharma. The ideal candidate will have expertise in... ..., ensuring compliance with cGMP standards. Responsibilities... ...project design, engineering validation, and collaborating with multi...Relocation package
- ...Process Safety Engineer Research Triangle Park, NC Vulcan Elements is manufacturing American rare-earth permanent magnets for a secure... ...of the site's PSM program in accordance with OSHA 29 CFR 1910.19 and EPA RMP requirements. Develop, implement, oversee...Permanent employmentFor contractorsLocal area
- ...offers an exciting opportunity for a skilled engineer to impact the efficiency, quality, and... ..., you will be pivotal in supporting cGMP production operations through expertise... ...process engineering, technology transfer, and validation. Working closely with cross‑functional...
- ...ASIC Design/Verification Engineer This role has been designed as 'Hybrid' with an expectation that you will work on average 2 days... ...complex products, solutions, and platforms, including design, validation, and testing. Reviews and evaluates designs and project activities...Work at officeLocal area2 days per week
- A leading tech company in North Carolina is seeking a Senior Design Verification Engineer specializing in GPU memory subsystems. The role requires collaboration to develop design verification strategies, performing advanced functional and performance verification, and...
- We are looking for a Verification Engineer for our Memory Management Unit at NVIDIA. Responsibilities Understand the design and implementation with a focus on the Memory Management Unit, define verification scope, develop verification infrastructure (testbenches, BFMs,...
- NVIDIA Gruppe is seeking a Senior Design Verification Engineer to join their GPU memory subsystem team in Durham, NC. You will collaborate with various teams to develop effective design verification strategies for GPU ASIC memory subsystems. The ideal candidate will have...
- NVIDIA Gruppe is seeking a Verification Engineer for the Memory Management Unit. This role involves defining verification scope, developing test infrastructure, and collaborating with engineers across sites. The ideal candidate has a degree in Electrical Engineering or...
- NVIDIA Gruppe is seeking a Senior Verification Engineer to lead efforts in verifying the Memory Management Unit for our advanced GPUs. This role demands strong expertise in ASIC verification and collaboration across teams to ensure top-tier design quality. The ideal candidate...
- Novartis Group Companies is seeking a Process Engineer III in Durham, NC. This pivotal role involves supporting the design and management of manufacturing processes, ensuring compliant and efficient operations within a regulated environment. Applicants should have a Bachelor...
- Accentuate Staffing is seeking dependable and detail-oriented Entry Level Packaging Associates to support packaging operations within a biotech/pharmaceutical manufacturing environment. This role is highly hands-on and involves repetitive tasks, working on packaging lines...Contract workMonday to FridayDay shift
- KBI Biopharma, Inc. in Durham, NC, is seeking a highly skilled Process Engineer to support cGMP operations, ensuring that manufacturing process equipment is maintained and optimized. The Process Engineer will lead projects that improve current processes and implement new...
$65k - $90.82k
...learn from our experiences to enhance our collective expertise Position Summary The CSV/CQV Engineer will support the commissioning, qualification, and validation of process equipment, utilities, facilities, and PAT systems. This role is responsible for all computerized...Temporary workWork experience placementLocal area- The Patient Specific Design Automation Engineer is responsible for developing and maintaining... ...and technical specifications. Test, validate, and troubleshoot automation scripts to... ...medical device design (ISO 13485 and FDA 21 CFR 820) #J-18808-Ljbffr Page Mechanical...
- ...advanced laboratory automation systems. You will work hands-on to deliver reliable and compliant automated workflows in a regulated lab environment. This role requires a Bachelor's degree and a minimum of 5 years' experience in laboratory operations or automation programs...
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