Principal Validation Engineer

Rentschler Biopharma•Milford, MA

1d•$140,000 - $170,000•Onsite

About The Position

The Principal Validation Engineer position at Rentschler Biopharma Inc is a member of Validation Team who demonstrates hands-on experience in developing and executing specifications, operating procedures, commissioning/qualification/validation (CQV) protocols and reports to perform Validation Life cycle of generation, execution, and reports for (DQ, FAT, SAT, IOPQ) of Manufacturing, QC, and Supply Chain process equipment and maintain them in validated state. This position is responsible for lifecycle qualification of our manufacturing facilities to support concurrent manufacturing operations.

Requirements

Bachelor’s Degree or equivalent in Engineering (Chemical, Chemistry, Biology, Electrical, Mechanical, etc.), Life Sciences, or related scientific discipline
7+ years of hands-on, direct validation experiences in pharmaceutical / biotech industries, including minimum 3 years of managing projects (CAPEX/OPEX)
Champion to adopt / apply principles of ASTM E2500 in CDMO manufacturing operations environment
Must have experience with cGMPs and Good Engineering Practices
Excellent technical writing ability for technical and compliance reports or submission

Nice To Haves

Experience in managing multiple projects and leading cross-functional project teams desired
Detailed knowledge of disposable technology preferred
Working experience with the contract development manufacturing and sterile / aseptic operations with a demonstrated knowledge of the general operation of pharmaceutical manufacturing and testing equipment
Strong communication, prioritization, and organizational skills, attention to details

Responsibilities

Maintain Equipment/Facility/Utilities (EFU), Computerized System (CSV) and Cleaning Validation programs in accordance with the Site Validation Master Plan and its corresponding policies and procedures
Lead complex, high-priority validation projects that often require considerable resources and high levels of function integration
Demonstrate skills set, knowledge and apply ASTM E2500 principles, and good engineering practices to the Site Validation Lifecycle concept
Assure good and timely communication of validation projects status and potential issues and/or roadblocks
Work with cross functions or stakeholders to resolve escalations or redirect the project as required
Apply a science and risk-based approach for CQV activities to assess the need and/or extent of required validation efforts
Collaborate with Manufacturing, Engineering, Process Support, Supply Chain, Quality and Regulatory Affairs to ensure that Commissioning Qualification Validation (CQV) project deliverables are compliant with the current regulations, current industry practices, and internal policies and procedures
Provide leadership by training Engineering team members on validation programs and protocol life cycle
Lead Validation Specialists to resolve technical challenges, analyze validation data and coordinate scheduling of qualifications with operational teams
Recommend best practices towards system operation and capital planning based upon validation principles and current industry practices
SME for Validation documents in support of regulatory and client audits
Own Quality System elements to include SOPs, CAPAs, Change Controls, Deviations, and Investigations
Perform Annual Product Quality Review for validation of manufacturing systems and processes
Provide expertise in cycle development and validation of complex pharmaceutical manufacturing equipment-cleaning processes
As applicable, perform Validation Life cycle of generation, execution, and reports for (DQ, FAT, SAT, IOPQ) of Manufacturing, QC, and Supply Chain equipment. (Cleaning, temperature mapping, sterilization)