Senior CQV Engineer: Validation, Analytics & GMP
Merck & Co.
Merck & Co. is seeking a Sr CQV Engineer to lead the commissioning and qualification of equipment and systems at the Holly Springs site. This role requires a Bachelor's degree in Data Science, Biotechnology, or Chemical Engineering and offers an opportunity to work in a dynamic and regulated environment. The candidate will be responsible for ensuring compliance with GMP standards, supporting technical transfers, and mentoring junior engineers. Experience with statistical process control and process analytics is preferred. #J-18808-Ljbffr Merck & Co.
- ...Holdings America Corporation is seeking a Sr CQV Engineer 1 in Holly Springs, NC, to lead the... ...overseeing the CQV team throughout the validation lifecycle and ensuring adherence to... ...commissioning. The position also requires strong analytical skills and the ability to work...Senior
- NCBiotech in Holly Springs, NC is seeking a Sr. Engineer 1 to lead the commissioning and qualification of equipment and systems. This... ...fields. The successful candidate will guide a team through the validation lifecycle, ensuring compliance with regulatory requirements...Senior
- Position Overview The Sr CQV Engineer 1 leads the commissioning and qualification... ...the CQV team through the validation lifecycle, investigation of... ...processes from a process analytics perspective Serves as on‑call... ...Manufacturing Practices (GMP) environment Provides technical...Senior
$110k - $150k
Piper Companies is seeking a CQV Engineer (Downstream DSM 3 & 4) in Holly Springs, North Carolina... ...commissioning, qualification, and validation efforts within a cutting-edge biologics... ...strong field execution experience in a GMP-regulated setting. This position offers...Suggested$87.78k - $136.23k
...our collective expertise We are seeking a CQV Engineer with hands-on experience supporting... ...focus on commissioning, qualification, and validation activities for CIP systems and related process... ...supporting CQV activities within GMP-regulated pharmaceutical or biotechnology...SuggestedTemporary workWork experience placement$107.8k - $168.01k
...We are seeking an Upstream Principal CQV Engineer is responsible for overseeing the commissioning... ...Experience supporting CQV activities in GMP-regulated pharmaceutical or... ...purification systems ~ Strong understanding of validation lifecycle documentation (IQ/OQ/PQ,...Temporary workWork experience placement- Job Title: Senior Validation Engineer (CSV), Biotechnology - (JP15063) Location: Holly Springs, NC. 27540 Employment Type: Contract Business Unit... ...include support in development of audit readiness materials and gmp documentation generation and review. This is an on site...SeniorPermanent employmentContract work
$45 - $50 per hour
A leading consulting firm is seeking a Senior Engineer for a remote role focusing on GMP Drug Substance manufacturing and tech transfer. The ideal candidate must have strong expertise in GMP processes and experience in technical problem-solving. This position requires periodic...SeniorRemote job- Merck & Co. is seeking a CQV Engineer 3 to support the commissioning and qualification of equipment and systems. This role involves validation activities such as equipment setup, creating dashboards, and managing protocols to ensure compliance with regulatory requirements...
- Job Title: Engineer Senior, Biotech GMP Drug Substance manufacturing, tech transfer - Remote (JP14709) Location: Holly Springs, NC. 27540 Employment Type: Contract Business Unit: DST Business Operations Duration: 6+ months with likely extensions and/or conversion to...SeniorRemote jobPermanent employmentContract workLocal area
- Amgen is seeking a Senior Manufacturing Systems Engineer to provide automation leadership within their Holly Springs facility. You will develop and maintain process control systems, ensuring compliance with GMP standards. The ideal candidate will have a degree in Engineering...Senior
- Amgen is seeking a Clean Utilities Sr. Engineer in Holly Springs, NC to oversee utility systems for drug production. The ideal candidate will have extensive experience in engineering within a GMP environment and will lead projects involving system improvements and compliance...Senior
- A leading consulting firm is seeking a Senior Validation Engineer (CSV) in Holly Springs, NC. This role focuses on ensuring compliance with validation standards for computer systems. Responsibilities include system design participation, test protocol preparation, and quality...Senior
- Initial Therapeutics, Inc. in Holly Springs, NC is seeking a Senior Manufacturing Systems Engineer specializing in automation to provide technical... ...The ideal candidate will possess extensive experience in GMP environments and particularly with Emerson DeltaV systems...Senior
- Position Overview The Senior Engineer or Scientist of Process Validation ensures that manufacturing processes meet the validation and regulatory requirements... ...other validation studies Partners with Validation (CQV) to support Performance Qualification execution and assessments...Senior
- Merck & Co. is seeking a Senior Engineer or Scientist of Process Validation to ensure that manufacturing processes meet validation and regulatory requirements. This role involves designing and documenting process validation protocols while collaborating with cross-functional...Senior
- ...Qualifications Bachelor’s Degree in Engineering or related technical field 1–5+ years of experience in CQV, validation, or pharmaceutical/biotech manufacturing At least 1 year... ...Strong experience with IQ/OQ/PQ execution, GMP documentation practices, ability to troubleshoot...
- Position Overview The QA Engineer, DSM Operations is responsible to help drive the Quality... ...to ensure Manufacturing Systems are first validated and then maintained in a validated state... ...experience • 3+ years of experience working in a GMP regulated environment • Experience in...Shift workDay shift
$110k - $150k
Piper Companies is seeking a CQV Engineer (Downstream DSM 3 & 4) to support commissioning, qualification, and validation efforts within a cutting‑edge biologics manufacturing environment... ...downstream bioprocessing systems within a GMP‑regulated setting. Responsibilities of the...- Job Title: Senior Cleaning Validation Engineer (On‑Floor Execution Lead) (JP15180) Location: Holly Springs, NC 27540 Employment Type: Contract Business Unit: NPI and MFG Systems Duration: 1+ year (with likely extensions and/or conversion to permanent) Posting Date:...SeniorPermanent employmentContract workMonday to FridayShift workNight shiftWeekend work
$148.72k - $201.2k
Amgen Senior Manager Manufacturing System Engineering - Bulk Drug Substance - Upstream Amgen’s next... ...in alignment with GMP requirements. Collaborate... ...DeltaV DCS. Support panel validation and Automation Installation... ...with Process Analytical Technology (PAT) tools and...Senior- Senior Manager Process Engineering Downstream In this vital role, you will oversee the... ...equipment in alignment with GMP requirements, while... ...construction, startup, and validation. Develop equipment maintenance... ...communication/presentation skills. Analytical skills to evaluate and...SeniorWork experience placementLocal area
- Senior Manager Manufacturing System Engineer - Bulk Drug Substance - Upstream Job responsibilities... ...in alignment with GMP requirements, while working... ...with Process Analytical Technology (PAT) tools and... ...actions, and qualifications/validation. Experience with Tech Transfer...Senior
- Senior Manufacturing Systems Engineer: Automation What you will do As a Senior Manufacturing... ...that support the GMP Drug Substance Plant Operations... ...different platforms, analytical problem‑solving techniques... ...supporting computerized systems validation processes in a GxP...SeniorLocal area
- ANC1 F&E Engineering If you feel like you’re part of something... ...company by 2027. Senior Manufacturing Systems... ...that support the GMP Drug Substance Plant Operations... ...different platforms, analytical problem‑solving... ...computerized systems validation processes in a GxP environment...SeniorRemote workWorldwideMonday to FridayFlexible hoursAfternoon shift
- Senior Manufacturing Systems Engineer: Automation- DeltaV Be part of Amgen's newest and... ...platforms that support the GMP Drug Substance Plant... ...between different platforms, analytical problem‑solving techniques... ...computerized systems validation processes in a GxP environment...SeniorRemote workMonday to FridayFlexible hoursAfternoon shift
- ...SA in Holly Springs, North Carolina, is seeking a Process Analytical Engineer to ensure compliance and operational readiness of laboratory... ...role, you will support manufacturing teams, lead instrument validation efforts, and develop maintenance programs to ensure peak...
$78.9k - $146.5k
...Packaging/Finished Products). The Sr MES Engineer is being hired to participate in... ...qualification protocols and maintaining the validated state of systems. Initial Project Focus:... ...drug product manufacturing processes in a GMP environment. System Implementation: Support...SeniorFull timeWork at officeLocal areaRelocation- DPS Group Global is looking for a skilled Project Engineer with electrical expertise to support our pharmaceutical client in the Raleigh-... ...significant experience with electrical processes and commissioning in a GMP environment. The role involves managing project schedules and...
- SR. ENGINEER, PD PROCESS VALIDATION & BUSINESS STRATEGY What You Will Do Lead the development of Process Validation/Process Performance Qualification strategy for New Products, aligned with regulatory guidelines and industry standards. Apply upstream (cell culture) and...SeniorFlexible hours
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