- Insmed Incorporated (San Diego, CA)
- …for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Senior Process Engineer will play a key role within the Manufacturing ... in the GMP QC lab, with emphasis on commissioning, qualification (C&Q), validation , and equipment reliability.Design, procure, and upgrade QC equipment to align with… more
- Repligen (Rancho Dominguez, CA)
- …bioprocessing manufacturing systems. Lead projects in equipment design, tech transfer, process validation , and facility upgrades. Conceives, plans, and executes ... is highly desirable. Hands-on experience with: Tangential Flow Filtration (TFF) Process validation and equipment qualification Tech transfer between sites… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …instrumentation and equipment start-ups from the laboratory through manufacturing scale. The Process Engineer I will work alongside Process Associates ... The Position This role will be part of our manufacturing downstream purification process support team, dedicated to one of our manufacturing suites. Responsible for… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …role will be commensurate with experience. Relationships Reports to: Lead Engineer , Manufacturing Engineering (Supervisor) Essential Functions Leads process and ... representative for contractor services including design, fabrication, installation, and validation Point person for process improvement activities, including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …while liaising with other functions including but not limited to Tech Support, Process Improvement, Validation , Supply Chain, Operations, QA, Reg CMC, and IT. ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking MES Engineer as part of the Manufacturing Excellence team based in Raritan, NJ. Role… more
- Novo Nordisk Inc. (Durham, NC)
- …practices, to include increasing awareness of data management standards & validation to create improvements in methods, techniques, approaches etc. for optimization ... of data sources Support manufacturing, business, and project departments with process understanding, analyses, and systematic problem solving Remain current with… more
- Katalyst HealthCares and Life Sciences (Hathorne, MA)
- Roles & Responsibilities: Process Validation (IQ/OQ/PQ). Product development experience. Process development. Process Layout, Modeling, and ... Process Development and Characterization. Test Method Development and Validation . Developing / Updating MPIs. Supplier Development and Component Engineering.… more
- Katalyst HealthCares and Life Sciences (Manitou Springs, CO)
- Responsibilities: Lead and manage the Process Validation and Verification qualification at the plastic suppliers and other commodities across IGTD portfolio. ... background in Manufacturing Engineering or/and Product Quality Engineering to drive the Process Validation and Verification at the suppliers. I would like to see… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Senior Engineer in Device Design and Process Development group, you will be part of our Research & Development team that designs and develops ... for this area, you will partake in medical device assembly and process development using semi-automated and automated equipment, conduct functional testing, assist… more
- Merck & Co. (Rahway, NJ)
- …in design controls, risk analysis, control strategies, design verification testing, and process validation , with a strong understanding of quality management ... relevant quality management systems.Qualifications:Bachelor's degree in Mechanical Engineering, Biomedical Engineer , or a related a technical field (eg, Chemical… more
- Grand River Aseptic Manufacturing (Grand Rapids, MI)
- …dedicated individuals improving lives every day. Overview of this Position: The Sr. Validation Engineer supports validation of cGMP equipment, facilities and ... processes, and utilities. This position will focus on in process validation . Non-Negotiable Requirements: Completion of a...a bachelor's degree in Engineering is required for the Engineer role. Completion of a bachelor's degree in life… more
- Katalyst HealthCares and Life Sciences (Marlborough, MA)
- …product Risk Management File (RMF). Advise R&D team members on execution of process validation (IQ/OQ/PQ) activities and metrology best practices. Support R&D ... of statistical data analysis, methods, and tools (Minitab or equivalent). Experience with test method validation (TMV), Gage R&R and process capability analysis. more
- Actalent (Golden, CO)
- Job Title: Validation Engineer Job Description As a Validation Engineer , you will play a crucial role in ensuring the validation of equipment within ... tasks. Essential Skills 4-7+ years of experience as a Manufacturing/ Validation Engineer . Proficiency in IQ/OQ/PQ validation...as the modification or adjustment of the job application process or interviewing due to a disability, please email… more
- PharmEng Technology (Portsmouth, NH)
- About the job Equipment Validation Engineer It's an onsite Job Summary: The Equipment Validation Specialist (Levels III & IV) ensures all critical GMP ... systems are validated and maintained in compliance with user requirements, process parameters, and global regulatory guidelines. The role provides Operations,… more
- Cytiva (Miami, FL)
- …equipment Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), process validation (PV), cleaning validation (CV) ... and approve deviation investigations, corrective and preventative actions (CAPAs), process improvements related to equipment qualification and validation … more
- Automation Technical Resources (Allendale, NJ)
- A 6 month contract opportunity is available for a Validation Engineer . Start is end of February 2025. Scope of work is Aseptic Process Validation in a ... Life Sciences Environment. This includes designing and writing the validation protocols, overseeing the execution and documentation. The majority of work can be… more
- PsiQuantum (Milpitas, CA)
- …talent to join us on this extraordinary journey! Job Summary: The cryogenic validation engineer will be responsible for the design characterization and ... validation of cryogenic electro-optical assemblies. This includes the development...for bank account information as part of the interview process . Please report any suspicious activity to ###@psiquantum.com We… more
- Actalent (Winston Salem, NC)
- This validation Engineer is tasked with supporting laboratory instrumentation and computerized systems within a GMP-regulated environment, with an emphasis on ... in QC testing, analytical, and microbiological analysis instruments. The engineer provides technical oversight, manages qualification activities, and ensures… more
- Takeda Pharmaceutical Company Limited (Lexington, MA)
- …the following job opportunity: JOB LOCATION: Lexington, MA POSITION : Sr. Cleaning Validation Engineer II POSITION DESCRIPTION : Shire Human Genetic Therapies, ... the "Apply" button, I understand that my employment application process with Takeda will commence and that the information...Inc. is seeking a Sr. Cleaning Validation Engineer II with the following duties:… more
- Pharmavise (Lebanon, PA)
- …Our Fortune 500 Pharmaceutical client has an exciting opportunity for a Validation Engineer (Automation). Job Summary: We are seeking a ... Validation Engineer (Automation) with experience in Commissioning and Qualification (C&Q)...the C&Q Lead Assist in gathering data for C&Q process metrics as assigned by the C&Q Lead Review… more
