Senior Validation Engineer (GMP/CSV) - Lead & SME
BW Design Group
BW Design Group is seeking a Validation Engineer III in Boston, MA, to provide expert-level support in ensuring that facility equipment and processes are qualified under cGMP standards. This role involves leading validation projects, authoring protocols, and guiding teams across functions. Candidates should possess a Bachelor's degree in Engineering or Life Sciences and have at least 5 years of relevant experience in regulated environments. Strong technical writing and project management skills are essential, along with knowledge of cGMP regulations. #J-18808-Ljbffr BW Design Group
$82.01k - $113.3k
A leading biotechnology company is seeking a Senior Laboratory Operations Associate to manage high-volume laboratory operations. The ideal candidate will have... ...years of hands-on experience in high-hazard chemistry and GMP settings. Responsibilities include coordinating daily...Senior- A government contracting firm in Boston seeks a Senior Relativity SME to join an experienced team. You will provide advanced-level support for Relativity, conduct training, and create user documentation. Ideal candidates need at least ten years of litigation support experience...Senior
$71.25k - $161.7k
A biotech company in Boston is seeking a Senior Associate in Quality Control. This position involves performing potency testing in compliance with GMP standards. The ideal candidate will have a Bachelor’s degree and at least 3 years of experience in the pharmaceutical industry...Senior- ...integrated architecture, engineering, construction, system... ...****Job Summary**The Validation Engineer III will... ...Subject Matter Expert (SME) responsible for leading validation activities... ...system validation (CSV) + Process validation... ...disciplines* Experience with GMP utilities (WFI,...SuggestedFor contractorsWork at office
- BioSpace is seeking a Senior Engineer I to operate at the intersection of automation engineering and bioassay... ...in Norwood, Massachusetts. This role involves leading automation solutions that transform prototypes into GMP-ready systems while collaborating across teams....Senior
- Creative Solutions Services, LLC is looking for a Quality Assurance Specialist in Boston, Massachusetts. The role involves overseeing the management of raw materials, ensuring compliance with cGMP standards, and supporting vendor investigations. Candidates should have a...Senior
- AECOM is seeking an Environmental Engineering Discipline Lead to join their Remediation team in Providence, RI. This role involves providing technical leadership in environmental remediation systems and evaluating complex sites. Candidates should have a Bachelor’s degree...Senior
- ...A leading healthcare institution in Boston seeks a Sr. Principal Scientist to oversee operations in a GMP lab, focusing on the production and quality control of radiopharmaceuticals. The ideal candidate will have extensive experience in aseptic operations, knowledge of...Senior
$115k - $140k
...process development, produce GMP viral vectors, and... ...of the process that leads to new cures. WORKING... ...leading computerized systems validation projects. This includes... ...procedures related to CSV validation practices... ...a Bachelor's degree in Engineering, Computer Science or...SeniorContract workLive inWork at officeVisa sponsorship- Verista is seeking a Senior Quality Engineer / Senior Quality GxP Auditor to provide QA oversight for GMP manufacturing operations in cell and... ...strong knowledge of cGMP, validation, CAPA, and deviation investigations, with experience leading GMP investigations and implementing...Senior
- Catalent is seeking a Validation Specialist at their facility in Chelsea, Massachusetts. This... ...validation activities within a GMP manufacturing environment, ensuring compliance... ...experience in validation, a Bachelor's degree in Engineering, and a strong understanding of relevant...Monday to Friday
$50k
...experience collectively. The Validation SME, with Delivery... ...Mission - to be the leading provider of... ...Experience 15+ years’ engineering experience in GMP regulated environment... ...Sciences or GMP. CQV and CSV expertise with... ...will be eligible for Senior Leadership Incentive...Temporary workFor contractorsWork at officeWeekend work- 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,...
- ...seeking an experienced CQV Engineer to support a GMP facility restart within a biologics... ..., qualification, and validation activities across upstream and... .... Key Responsibilities Lead and execute CQV activities for... ...Experience with Annex 11 / CSV (Computer System Validation)...
- Emergent Biosolutions in Canton, MA is searching for a Sr. Manager, QA Compliance to ensure GMP compliance and regulatory inspection readiness. This role is pivotal in leading internal audits and supplier quality oversight, ensuring alignment with global standards. The...Senior
$147k - $167k
Praxis Precision Medicines, Inc. is seeking a Senior Manager, Analytical Sciences - Commercial to lead analytical strategies for commercial products. This position... .... The role requires substantial experience in GMP environments with a strong background in small molecule...SeniorRemote job- Highmark Inc. is seeking a senior pharmacist to balance clinical and business acumen in a hybrid model (T,W,TH) for employees within... ...partners to implement and improve them. The incumbent will lead program SME activities, monitor outcomes, ensure compliance, educate...SeniorWork at office
- Meet Life Sciences is looking for a Senior CQV Engineer in Watertown, Massachusetts. This role leads commissioning, qualification, and validation activities for GMP manufacturing equipment and utilities, ensuring compliance with regulatory requirements. The ideal candidate...Senior
- ...Supervisor for their Manufacturing team. This role entails overseeing GMP manufacturing processes, managing a team of technicians, and... .... The ideal candidate will have a background in science or engineering and at least five years of experience in GMP manufacturing, preferably...
$118.1k - $157.5k
SimpliSafe is looking for a Senior RF Test & Validation Engineer in Boston, MA, to lead RF product development and ensure best-in-class wireless connectivity. This role involves developing testing capabilities, ensuring the integrity of RF designs, and working closely with...Senior$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... ...and extensive background in engineering or sciences. Salary is competitive...Hourly pay$82.3k - $220k
Draper Labs in Cambridge, Massachusetts is hiring a Senior Analog ASIC Validation Engineer. This role involves specifying, designing, and validating integrated circuits through all phases of product development. Candidates should have a bachelor's degree in Engineering...Senior- Vertex Pharmaceuticals Inc. in Boston seeks a Facilities Engineering Manager to lead engineering efforts across clean utilities, equipment, and infrastructure... ...design reviews, risk assessments, and safety reviews for GMP‑regulated capital projects, while standardizing practices...Senior
$118.1k - $157.5k
...Home Secure. What You'll Do As a Senior RF Test Engineer, you will be a key technical leader... ...responsible for RF product development and validation at SimpliSafe. You help design and... ...designs for RF performance. You will also lead and guide our ODMs design partners in...SeniorWork at office$70.49k - $118.06k
...project status, risks, and issues to stakeholders. Requirements Bachelor’s degree in Information Technology, Computer Science, Engineering, or related field, or equivalent experience. 3+ years of IT support experience in laboratory, scientific, pharmaceutical, biotechnology...Senior$60 - $65 per hour
Overview Role: Validation & Quality Assurance Consultant (GMP) Location: Boston, MA (Onsite - Monday to Friday) Employment... ...the Role We are seeking a Quality Engineering and Validation Consultant to... ...protocol review and execution. Lead and support event investigations,...Hourly payContract workMonday to Friday- 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...
$82.3k - $220k
...From military defense and space exploration to biomedical engineering, lives often depend on the solutions we provide. Our... ...necessary for true innovation. Job Description Summary: A Senior Analog ASIC Validation Engineer specifies, designs, verifies, tests, and validates...SeniorFull time$83.5k - $149.5k
SharkNinja in Needham, Massachusetts is seeking a Senior Quality Engineer to ensure quality in the Shark Haircare team. The role focuses on design validation and engineering, collaborating with teams to meet high-quality standards. Qualified candidates will have a Bachelor...Senior$92k - $148.35k
...Product Development Job Sub Function R&D Software/Systems Engineering Job Category Scientific/Technology All Job Posting... ...the best talent to join our Orthopaedics team as a Senior Robotics Verification & Validation (V&V) Engineer to be located in Raynham, MA or Boston,...SeniorWork at officeLocal areaImmediate start3 days per week
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