GMP Validation Engineer: C&Q Lead for Pharma/Biotech
ACL Digital
ACL Digital located in Holly Springs, North Carolina is seeking a qualified candidate to lead and execute commissioning and qualification activities on GMP analytical and process equipment. Responsibilities include generating and reviewing C&Q protocols and executing C&Q plans. Effective communication skills and the ability to manage time efficiently are essential for this role. The successful candidate will have demonstrable experience in a pharmaceutical setting, knowledge of cGMP practices, and familiarity with digital C&Q systems like Kneat Gx Platform. #J-18808-Ljbffr ACL Digital
$109k - $204k
...requires strong leadership and project management skills, guiding teams through the C&Q lifecycle to support GMP operations. Candidates should have a Bachelor's degree in Engineering and 8+ years of relevant experience within the biopharmaceutical industry. Fluency in...SuggestedRemote work- CSL is seeking a Validation Specialist III in a GMP environment to manage validation activities for equipment and computer systems. The role requires... ...Systems. You will develop protocols, perform analyses, and lead major validation efforts within the facility. Ideal...Suggested
- Primarily responsible for leading and/or executing... ...activities on new or modified GMP analytical and process... .../reviewing/executing C&Q protocols, plans, and summary... ...in a pharmaceutical, biotech, or life science... ...commissioning/qualification/validation practices. Familiarity...Suggested
- A Quality Assurance firm in Holly Springs, NC is searching for candidates for a Quality Assurance role. The responsibilities include supporting Quality oversight for commissioning and qualification activities, managing vendor relationships, and ensuring compliance with ...Suggested
$50 - $55 per hour
A leading consulting firm in Holly Springs, NC, seeks a professional to ensure compliance with computer validation standards in systems. Responsibilities include guiding documentation quality, participating in system design, and providing IT compliance guidance. The role...SuggestedHourly payFull time$145.24k - $170.8k
Manufacturing Procurement Site Lead Join to apply for the Manufacturing Procurement Site... ...Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest... ...to regulatory requirements (e.g., GLP, GMP, ISO) and implement quality control systems...Remote workFlexible hours$107.8k - $168.01k
...a Clean-in-Place (CIP) CQV Engineer with hands-on experience overseeing... ...and qualification (C&Q) lead for CIP systems (responsibilities... ...supporting CQV activities within GMP-regulated pharmaceutical or... ...~ Experience using digital validation platforms such as Kneat ~ Experience...Temporary workWork experience placement- Amgen in North Carolina seeks a Maintenance Manager to lead a GMP-focused maintenance team. You will plan, troubleshoot, repair, and improve reliability of equipment, while managing staff performance and ensuring regulatory alignment. You will set strategic goals with...Day shift
- ...in Holly Springs, North Carolina is seeking a Manager for Manufacturing Services to lead the Material Management Team on a night shift. The role focuses on guiding a diverse team in GMP operations, overseeing inventory control, and ensuring compliance with regulations....Night shift
- FUJIFILM Biotechnologies in Holly Springs, NC, seeks a Sr. Analyst 1, QC Microbiology to lead advanced microbial testing of in-process and finished materials, train staff, and drive QA/GMP-compliant laboratory operations. The role emphasizes aseptic production, method...
- ...helped pioneer the world of biotech in our fight against... ...27. Senior Electrical Engineer What You Will Do In... ...the commissioning and validation of systems to ensure their... ...with requirements and GMP regulation and on-time... ..., and investigations. Lead identifying and implementing...Local areaFlexible hours
- Valspec is seeking a Validation Engineer (CQV) in the Raleigh-Durham area to lead commissioning, qualification, and startup activities for a large-scale biopharmaceutical... ..., field execution, and troubleshooting in a GMP environment. You will verify P&IDs and data sheets,...
- ...Job Description Job Description Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology... ...regulations and quality policies, procedures, and GMP standards. Apply statistical analysis and SPC...
- ...improving corporate quality management systems. The ideal candidate will possess a BS in Chemistry or related fields and have experience in GMP laboratory settings. This position also offers a range of benefits including medical, dental, and vision insurance, as well as...
- Amgen is seeking a Senior Manufacturing Systems Engineer to provide automation leadership for GMP Drug Substance Plant Operations. The role focuses on Emerson DeltaV DCS, capital projects, and collaboration with SMEs to deliver robust automation solutions. The incumbent...
- A leading validation solutions provider in Holly Springs, NC is seeking a Validation Engineer/Cleaning Validation Specialist I to coordinate cleaning validation activities and ensure compliance with GMPs. The ideal candidate will have a B.S. in Science, Engineering, or...Contract work
- ...A leading convenience store operator is looking for a C-Store Assistant Manager in Apex, NC. This role involves supporting the Store Manager, overseeing daily operations, hiring and training staff, and maintaining a customer-focused store environment. The ideal candidate...Daily paidFull timeFlexible hours
- FUJIFILM Biotechnologies is looking for an Automation Engineer 3 in Holly Springs, North Carolina. The role focuses on supporting the Drug Substance Manufacturing facility, which includes Automation activities such as system updates, testing, and troubleshooting. Successful...
- FUJIFILM Biotechnologies in Holly Springs, North Carolina is hiring a Program Manager responsible for the planning and delivery of programs from contract signature through to closure. The role includes managing multiple programs, ensuring alignment with client commitments...Contract work
$87.78k - $136.23k
...collective expertise We are seeking a CQV Engineer with hands‑on experience supporting Clean... ...on commissioning, qualification, and validation activities for CIP systems and related process... ...supporting CQV activities within GMP‑regulated pharmaceutical or biotechnology...Temporary workWork experience placement- A biotechnology company in Holly Springs seeks a Manufacturing Specialist Single Use Systems (SUS) Lead to oversee Single Use Systems technology and ensure GMP compliance. The successful candidate will have experience in biotechnology operations, regulatory familiarity...
- ...coaching, and champion 5S education across all factories to build a culture focused on safety, quality, and efficiency. The role requires leading CI and 5S programs, coordinating batch planning, and ensuring accurate documentation and change management. #J-18808-Ljbffr...
- Amgen in Holly Springs seeks a Manager Manufacturing (Downstream) for Night Shift. You will lead a team of manufacturing associates in a critical biopharmaceutical environment, ensuring operations align with compliance standards. Candidates should possess leadership skills...Night shift
- A leading staffing firm is seeking a Maintenance Coordinator for onsite work at a pharmaceutical manufacturing plant in North Carolina. This role supports GMP-compliant operations by planning and coordinating maintenance activities to ensure equipment reliability and minimal...
- ...1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest... ...Manufacturing - Continuous Improvement Lead What You Will Do In this vital role you... ...commissioning/qualification, start‑up, engineering run, and process performance qualification...Local area
- ...Overview The Lead Warehouse Associate position is responsible... ...while operating in a GMP facility with standard operating... ...and commissioning support with validation, and start up activities with... ...Bachelor’s degree in life Sciences, Engineering, or Business with 4 years...Shift workNight shiftWeekend work
- ...candidate: 8+ YOE Must have field execution experience. Lead the execution of all Cleaning Validation activities (CV/SIP PQ/CHT/SHT studies), including... ...teams, including Quality Assurance, Manufacturing, and Engineering, to ensure cleaning validation activities are...Monday to FridayShift workNight shiftWeekend work
- A leading biotech company in Holly Springs is seeking a Utilities Manager for Day Shift to provide leadership and management of plant utilities and maintenance programs. The role requires strong technical expertise and the ability to ensure compliance with safety regulations...Day shift
- ...Valspec—a global provider of system validation and lifecycle services—... ...innovative therapies. Validation Engineer (CQV) Location: Raleigh-... ...verification experience in a GMP-regulated environment. Key... ...commissioning and startup. Lead and execute mechanical...Immediate start
- ...for the Senior Process Engineer role at BioSpace . Be... ...helped pioneer the world of biotech in our fight against... ..., support, and/or lead implementation of engineering... ..., startup, and validation of equipment. Develop... ...completed in alignment with GMP requirements and interact...Full timeWork experience placementLocal areaFlexible hours
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