Actual Title: Process Engineer II
Location: Frederick MD
Currently role 100% on site
Responsibilities (include but are not limited to):
• Complete required training to maintain technical skill, technical knowledge, and ensure compliance with cGMP requirements
• Initiate deviation records in the Agile Quality Management System (QMS)
• Lead cross-function teams (Manufacturing, Quality, Facilities, MSAT, etc.) to perform root cause analysis of quality events
• Collaborate with stakeholders to develop and manage Corrective and Preventive Actions (CAPA)
• Additional duties as assigned
Basic Qualifications:
• BS or BA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with at least 5 years of relevant experience or
• AA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with at least 9 years of relevant experience or
• HS Diploma with 12 years of relevant experience in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent
Preferred Qualifications:
• Strong skill in technical writing
• Strong skill in organization
• Strong skill in quality record management
• Experience in owning and investigating deviations
• Experience in implementing CAPAs
• Experience in cell culture or aseptic processing
• Experience in cGMP cell therapy manufacturing
• Experience with Quality Management Systems
• Working knowledge of pharmaceutical manufacturing of biotechnology products and process development
• Working knowledge of regulatory regulations and requirements for pharmaceuticals and devices
EEO:
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.” •
Last updated on Oct 26, 2023