CQV Validation Lead - Biologics GMP Restart
Barrington James
Barrington James is seeking an experienced CQV Engineer to support a GMP facility restart within a biologics manufacturing environment. This role involves leading CQV activities for process equipment and ensuring compliance with GMP standards. Ideal candidates will have 5-7 years of experience in validation, particularly within pharma or biotech sectors. Strong technical writing and an understanding of Annex 11 requirements are necessary. This position offers a dynamic and project-driven work environment. #J-18808-Ljbffr Barrington James
- ...Quality GxP Auditor to provide QA oversight for GMP manufacturing operations in cell and gene therapy... .... The role requires strong knowledge of cGMP, validation, CAPA, and deviation investigations, with experience leading GMP investigations and implementing effective CAPA...Suggested
- BW Design Group is seeking a Validation Engineer III in Boston, MA, to provide expert-level support in ensuring that facility equipment... ...processes are qualified under cGMP standards. This role involves leading validation projects, authoring protocols, and guiding teams...Suggested
- ...We are seeking an experienced CQV Engineer to support a GMP facility restart within a biologics manufacturing environment. This... ...commissioning, qualification, and validation activities across upstream and... ...setting. Key Responsibilities Lead and execute CQV activities for...Suggested
$118.4k - $177.6k
The GMP Quality Operations Manager is recognized internally as an expert in the principles... ...to improve overall Quality operations. Lead and participate in Cell & Genetic Program... ...products) strongly preferred or with Biologicals/sterile. Demonstrated AI skills and digital...SuggestedSummer work- Otsuka America Pharmaceutical Inc. is seeking a Senior Manager for Quality Control (Biologics) to execute and support QC activities across contract testing labs while ensuring compliance with cGMP and regulatory standards. This pivotal role involves overseeing analytical...SuggestedContract work
$60 - $65 per hour
A leading life sciences consulting firm is seeking a Validation & Quality Assurance Consultant to provide QA support for GMP operations in Boston. This role includes hands-on experience with validation activities, root cause analysis, and collaboration with cross-functional...Hourly pay- ...Valspec—a global provider of system validation and lifecycle services—... ...therapies. Validation Engineer (CQV) Location: Raleigh-Durham... ...verification experience in a GMP-regulated environment. Key... ...commissioning and startup. Lead and execute mechanical completion...Immediate start
- Redbock - an NES Fircroft company is seeking an experienced Quality Engineering & Validation Consultant to provide GMP quality oversight for manufacturing operations, validation activities, and capital projects in a regulated biopharmaceutical environment. You will partner...
- Catalent is seeking a Validation Specialist at their facility in Chelsea, Massachusetts. This role focuses on executing validation activities within a GMP manufacturing environment, ensuring compliance with FDA regulations. The ideal candidate will have at least 3 years...Monday to Friday
$60 - $65 per hour
Overview Role: Validation & Quality Assurance Consultant (GMP) Location: Boston, MA (Onsite - Monday to Friday) Employment Type: Contract Status: Accepting... ...activities, including protocol review and execution. Lead and support event investigations, root cause analysis,...Hourly payContract workMonday to Friday$115k - $164k
InterSystems in Boston is looking for a Technical Specialist to join our AI-focused team. You will develop methodologies to validate AI applications, ensuring their performance and security. The role offers a unique opportunity to engage in meaningful work with the latest...- ...Vertex Pharmaceuticals is seeking a GMP Quality Operations Manager to oversee quality assurance and compliance for their Cell & Gene Therapy manufacturing. This role focuses on operational efficiency, compliance, and AI-enabled solutions to enhance quality operations....
- A healthcare technology firm in Boston is seeking a Quality Assurance Specialist to perform inpatient DRG validation audits. The role requires at least 5 years of experience in reviewing ICD-10 claims and an understanding of coding standards. Responsibilities include conducting...Remote jobFull time
- Carda Life Sciences is seeking a Validation Engineer to perform validation activities within a GMP biotech manufacturing facility in Boston, MA. The ideal candidate will have a Bachelor's degree in engineering or science and over 10 years of experience in the industry,...
- ...Duties as assigned Requirements: ~ Bachelor's Degree in Biology, Microbiology, Food Science, Animal Science, Quality Assurance... ...Safety. ~ Familiarity with Regulatory Agencies. ~ Knowledge of GMP and GMP Audits. ~3-7 years of experience in Quality Assurance/...Local areaOverseas
$118.4k - $177.6k
Vertex Pharmaceuticals Inc (US) is looking for a GMP Quality Operations Manager in Boston, MA. This role requires expertise in quality assurance and compliance within a GMP-regulated environment, specifically for Cell & Gene Therapy programs. The manager will oversee quality...- Vertex Pharmaceuticals Incorporated is seeking a GMP Quality Operations Manager to lead quality assurance efforts for Cell and Gene Therapy manufacturing operations. In this role, you will drive and support product disposition activities, ensure compliance, and implement...
- Vertex Pharmaceuticals Incorporated in Boston is searching for an Associate Director, GMP Operational Quality to oversee team tasks and ensure quality deliverables. You will lead risk-based audits, manage QA processes, and mentor your team in a collaborative environment...
$82.01k - $113.3k
A leading biotechnology company is seeking a Senior Laboratory Operations Associate in Watertown, MA. This role requires 3-5 years of hands... ...laboratory operations focusing on high-throughput chemistry and GMP. The ideal candidate will manage laboratory operations, handle...- ...seeking a QC Supervisor – Microbiology to lead a team of Quality Control professionals supporting... ...performing microbiological testing in a GMP-regulated environment. Ensure laboratory... ...for Bachelor's degree in Microbiology, Biology, Life Sciences, or a related scientific...
- Accenture seeks a domain expert in CC&B and CCS for business validation in Boston. You will lead variance analysis, manage validation triage, and collaborate with various teams to ensure successful upgrades in a fast-paced environment. With a minimum of 7 years of functional...
- Boston University is seeking a Director of Operations for the College of Arts & Sciences, Biology. This role is crucial for managing all non-academic operations, ensuring efficient workflows, and supervising administrative staff while supporting departmental goals. The...
$118.4k - $177.6k
...addressed. Approves investigations/CAPAs. Identifies, facilitates, and/or leads continuous improvement efforts. Maintains Quality Metrics to support process improvement activities. Conducts GMP document review, including procedures, work instructions, specifications,...Work experience placementSummer workRemote workFlexible hours2 days per week$119k - $157.1k
...DESCRIPTION How you will make an impact: You will run Thermo Fisher’s Biologicals and Chemicals Division (BCD) marketing operations and shared... ...ROI discipline Maintain compliance with procurement processes Lead execution teams (Demand Gen / Events / Marcom) Set strategy and...Temporary workWork at officeRelocation- ...the CMC activities. The role requires at least 5 years of quality assurance experience in the pharmaceutical industry and expertise in GMP regulations. The candidate should have excellent communication and interpersonal skills, a strong track record in managing quality...Full time
$73.8k - $218.8k
...You Are A CC&B and CCS domain expert who specializes in business validation — the complex, multi-dimensional testing effort that confirms a... ...and keep a high‑volume triage cadence on track. The Work Lead Tier 1 and Tier 2 business validation variance analysis across...Work experience placementLive inWork at officeLocal area- PwC is seeking a Data Validation Risk Manager to leverage advanced analytics for client-focused data insights. You will lead teams, mentor staff, and manage projects across data quality, visualization, and predictive modeling to support strategic goals. You will collaborate...
- A leading firm in IT Services and Consulting is seeking a GMP Operational Quality Senior Specialist in Boston, MA. The role includes providing quality oversight and operational support for GMP manufacturing, requiring a strong background in QA operations and experience...
- ...and People First mindset. The Validation - Engineer I & II is an early-... ...deliverables. Perform CQV tasks, such as protocol development... ...equipment testing, under the Site Lead’s guidance. Report technical... ...requirements (e.g., FDA, GMP), and industry standards. Author...Full timeWork experience placementWork visa
- Vertex Pharmaceuticals is seeking an Associate Director, GMP Operational Quality in Boston to oversee team activities and ensure quality... ...of quality assurance and compliance principles. You will lead a team responsible for GMP manufacturing and testing activities,...
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