Validation Engineer
3 weeks ago
Vericel Corporation is seeking a highly skilled Validation Engineer to join our team in Cambridge, MA. As a key member of our validation team, you will be responsible for performing validation in a GMP biotech manufacturing facility.
Key Responsibilities:- Develop and execute validation project plans and protocols.
- Participate in equipment failure investigations and corrective/preventive actions.
- Provide technical assistance to less experienced technicians/specialists.
- Review and approve validation and calibration documentation.
- Bachelor's Degree or equivalent and 4+ years of validation experience.
- Master's Degree or equivalent and 2+ years of validation experience.
- 3+ years of experience with process, equipment, utility, and/or software validation in a GMP regulated environment.
- Proficient with GE Kaye Validator and/or ValProbe data acquisition systems.
- Working knowledge of GMPs.
- Excellent technical writing and verbal communication skills.
- May be required to work in classified and controlled areas such as clean room environment wearing special garments.
- May be required to lift, push or pull up to 40 lbs.
Vericel Corporation is an Equal Opportunity/Affirmative Action Employer. We are committed to diversity and inclusion in the workplace.
-
Validation Engineer, II
2 weeks ago
Cambridge, Massachusetts, United States Vericel Corporation Full timeJob SummaryVericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, seeks a skilled Validation Engineer, II to join our team in Cambridge, MA. As a key member of our validation team, you will be responsible for performing validation in a GMP biotech manufacturing facility.Key ResponsibilitiesDevelop and...
-
GxP Validation Specialist
1 month ago
Cambridge, Massachusetts, United States WHITE COLLAR TECHNOLOGIES INC Full timeJob Title: GxP Validation Engineer/AnalystWe are seeking a highly skilled GxP Validation Engineer/Analyst to join our team at White Collar Technologies Inc. This role will be responsible for providing support to the QC Analytical department in maintaining CGMP status of QC Instrumentation hardware and software, as well as performing comparability studies for...
-
Cambridge, Massachusetts, United States BioSpace, Inc. Full timeJob DetailsBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use.I further attest that all information I submit in my employment application is true to the best of my...
-
Clinical Data Validation Engineer
2 weeks ago
Cambridge, Massachusetts, United States Takeda Pharmaceutical Company Ltd Full timeTransforming the Pharmaceutical Industry through R&D-Driven Market LeadershipTakeda Pharmaceutical Company Ltd is a patient-focused company that empowers its employees to realize their potential through life-changing work. As a Clinical Data Validation Engineer - Associate Manager, you will play a vital role in our Cambridge, MA office, contributing to the...
-
Clinical Data Validation Engineer
1 week ago
Cambridge, Massachusetts, United States Takeda Pharmaceutical Company Ltd Full timeAt Takeda Pharmaceutical Company Ltd, we are seeking a highly skilled Clinical Data Validation Engineer to join our Clinical Data Sciences team. As a key member of our team, you will be responsible for ensuring the accuracy and integrity of clinical trial data.Clinical Data Validation Engineer Role:The Clinical Data Validation Engineer will be responsible...
-
Computer Systems Validation Specialist
6 days ago
Cambridge, Massachusetts, United States Sequoia Biotech Consulting Full timeJob SummarySequoia Biotech Consulting is seeking a highly skilled Computer System Validation (CSV) Engineer to ensure the integrity and reliability of computer systems and software used by our clients. The ideal candidate will have a strong background in regulatory requirements and industry standards, with experience in validation of various types of...
-
Medical Device Manufacturing Engineer
3 weeks ago
Cambridge, Massachusetts, United States MetaOption LLC Full timeJob Title: Medical Device Senior Manufacturing EngineerWe are seeking a highly skilled Medical Device Senior Manufacturing Engineer to join our team at MetaOption LLC. As a key member of our engineering team, you will be responsible for developing and optimizing efficient, cost-effective, and validated manufacturing processes for medical devices.Key...
-
Medical Device Manufacturing Engineer
2 weeks ago
Cambridge, Massachusetts, United States MetaOption LLC Full timeJob Title: Medical Device Senior Manufacturing EngineerMetaOption LLC is seeking a highly skilled Medical Device Senior Manufacturing Engineer to join our team. As a key member of our manufacturing team, you will be responsible for developing and optimizing efficient, cost-effective, and validated manufacturing processes for medical devices.Key...
-
Medical Device Manufacturing Engineer
4 weeks ago
Cambridge, Massachusetts, United States MetaOption LLC Full timeJob Title: Medical Device Senior Manufacturing EngineerMetaOption LLC is seeking a highly skilled Medical Device Senior Manufacturing Engineer to join our team in Boston, USA. As a key member of our team, you will be responsible for developing and optimizing efficient, cost-effective, and validated manufacturing processes for medical devices.Key...
-
Medical Device Senior Manufacturing Engineer
2 weeks ago
Cambridge, Massachusetts, United States MetaOption LLC Full timeMetaOption LLC is seeking a highly skilled Senior Manufacturing Engineer to join our team in Boston. As a key member of our USA's Boston Incubation Center, you will collaborate with world-class hospitals to turn cutting-edge medical research into usable products. Your expertise will be crucial in developing and optimizing efficient, cost-effective, and...
-
Medical Device Manufacturing Engineer
2 weeks ago
Cambridge, Massachusetts, United States JM Chandler Dream Builders Full timeJob DescriptionAt JM Chandler Dream Builders, we are seeking a highly skilled Medical Device Manufacturing Engineer to join our team. This is a unique opportunity to work on cutting-edge medical research and turn it into usable, meaningful products.The successful candidate will have high collaboration between R&D, Pilot, and commercial manufacturing,...
-
Medical Device Manufacturing Engineer
4 weeks ago
Cambridge, Massachusetts, United States RaiZan Solutions Full timeJob Title: Medical Device Senior Manufacturing EngineerWe are seeking a highly skilled Medical Device Senior Manufacturing Engineer to join our team at Raizan Solutions. As a key member of our engineering team, you will be responsible for developing and optimizing efficient, cost-effective, and validated manufacturing processes for medical devices.Key...
-
Senior Manufacturing Engineer
2 weeks ago
Cambridge, Massachusetts, United States KLM Careers Full timeJob DescriptionThe Senior Manufacturing Engineer will play a key role in the development and commercialization of new medical devices. This individual will collaborate closely with R&D, Pilot, and commercial manufacturing teams to ensure design and manufacturing processes are robust, scalable, and compliant with regulatory requirements.Key...
-
Medical Device Manufacturing Engineer
3 weeks ago
Cambridge, Massachusetts, United States JM Chandler Dream Builders Full timeJob DescriptionWe are seeking a highly skilled Medical Device Manufacturing Engineer to join our team at JM Chandler Dream Builders. As a key member of our engineering team, you will be responsible for developing and optimizing efficient, cost-effective, and validated manufacturing processes for medical devices.Key Responsibilities:Develop and optimize...
-
Process Engineer
2 weeks ago
Cambridge, Massachusetts, United States Global Channel Management Full timeAbout the JobWe are seeking a highly skilled Process Engineer to join our team at Global Channel Management.Key ResponsibilitiesDesign and initiate processes for manufacturing of chemicals and related products relative to assigned area.Ensure a safe working environment by following safety rules and helping improve the safety culture.Perform process...
-
Medical Device Manufacturing Engineer
3 weeks ago
Cambridge, Massachusetts, United States RaiZan Solutions Full timeAbout the RoleWe are seeking a highly skilled Medical Device Senior Manufacturing Engineer to join our team at RaiZan Solutions. As a key member of our engineering team, you will play a critical role in developing and optimizing efficient, cost-effective manufacturing processes for cutting-edge medical devices.Key ResponsibilitiesDevelop and optimize...
-
Microsystems Integration Engineer
4 weeks ago
Cambridge, Massachusetts, United States Draper Labs Full timeJob SummaryDraper Labs is seeking a highly skilled Microsystems Integration Engineer to join our team. As a key member of our Microsystems Integration Group, you will apply engineering principles to the transition to production of low-volume microelectromechanical (MEMS) devices. This includes technology readiness level maturation of miniaturized electronic...
-
Senior Manufacturing Engineer
3 weeks ago
Cambridge, Massachusetts, United States Enterprise EQ Full timeAbout the JobWe are seeking a highly skilled Senior Manufacturing Engineer to join our team at Enterprise EQ. As a key member of our manufacturing team, you will be responsible for developing and optimizing efficient, cost-effective, and validated manufacturing processes for medical devices.Key Responsibilities:Develop and optimize manufacturing processes...
-
Medical Device Senior Manufacturing Engineer
2 weeks ago
Cambridge, Massachusetts, United States KLM Careers Full timeJob DescriptionThe Senior Manufacturing Engineer will play a crucial role in the development and commercialization of new medical devices. This individual will collaborate closely with R&D, Pilot, and commercial manufacturing teams to ensure design and manufacturing processes are robust, scalable, and compliant with regulatory requirements.Key...
-
Process Engineer
2 weeks ago
Cambridge, Massachusetts, United States Global Channel Management Full timeAbout the JobWe are seeking a highly skilled Process Engineer to join our team at Global Channel Management.ResponsibilitiesDesign and implement processes for the manufacturing of chemicals and related products.Ensure a safe working environment by adhering to safety protocols and contributing to a positive safety culture.Provide technical support and...