Responsibilities and requirements: 4 to 5 years of Supplier Development experience. Experience in working in New Product Introduction. Good experience in Component Qualification (plastics & sheet metal). Experience in Process Valida...
Responsibilities: Follow up on supplier audits to demonstrate supplier controls required by FDA CFR 820, ISO 13485 and ISO 9000. Works with suppliers to find solutions to identified problems. Create written reports and communicate the...
Job Description Expert in CSA validation principles. Develop a strategy to convert existing CSV approaches to lab validation into a CSA documented process. Developing, reviewing, and executing testing documentation. Direct experience a...
Responsibilities: SAS Programming: You'll utilize advanced SAS programming skills to analyse and report clinical trial data (both safety and efficacy). If applicable, develops and provides department training for applications and standa...
Responsibilities: Familiar with PFMEA/DFMEA's. Gage R&R's. TMV's. Risk Assessments. Control Plans. Experience with equipment validations (IQ, OQ & PQ's). Related work experiences. Sand, Die Casting or Foam Castings. Wax or Plastic...
Responsibilities and Requirements: A minimum of eight (8) years of process/plant engineering experience in GMP MFG large molecule biologics facilities. Experience in green or brown field GMP MFG facility start-up including process syste...
Responsibilities: Lead the management of CDM deliverables in coordination with internal and external cross-functional teams. Lead by providing CDM expertise for data coordination, collection, and cleaning to efficiently ensure high qual...
diagnostic assays. A BS in Life Science or equivalent experience is required. Applicants with experience in a GMP/ISO regulated...
Responsibilities : This role is also called validation engineer role. Specifically looking for someone with electric motor and generator validation, if you have electric motor experience your resume will carry more value. This role wo...
+ years as a validation engineer/lead in Life Sciences industry. 3+ years qualifying infrastructure and applications...