What are the responsibilities and job description for the EQUIPMENT VALIDATION ENGINEER position at Tri Pac, Inc.?
VALIDATION ENGINEER
Job Description :
The Validation Engineer will demonstrate his / her knowledge of biologics manufacturing processes, including fermentation, purification, and bulk filling processes and work independently in a matrix team environment, influencing team decisions, and exercising sound judgement in determining compliant and robust validation approaches. He / she will have the ability to multi-task with a demonstrated track record in meeting deliverable timelines and must demonstrate the ability to think critically and analytically with acumen for troubleshooting and problem solving and is a strong team player aligned with company corporate values. Will have good interpersonal, verbal, and written communication skills and has the ability to function effectively and independently in a fast-paced and dynamic environment. He / she is self-motivated and willing to tackle assignments and development opportunities outside of job scope as needed. Has the ability to interpret engineering and facility drawings such as facility layouts, blueprints, material / process flow diagrams, and equipment P&IDs. Is an expert with Microsoft Word / PowerPoint and Intermediate Microsoft Excel skills and understands basic statistics, acceptance sampling, and is familiar with statistics software. Demonstrates hands on experience with facility / equipment / utility qualification, cleaning validation, process validation, and sterilization validation experience (steam sterilization and dry heat depyrogenation) in GMP environment and with CIP / SIP cycle development.
Responsibilities :
- Perform qualification of manufacturing equipment (liquid aseptic and aerosol aseptic), facility and utility systems (including CIP / SIP qualification), cleaning validation, computer system validation and process validation. Scope of responsibilities includes drafting of qualification protocols and summary reports, field execution, and data analysis.
- As needed coordinate and provide directions to contract personnel performing validation activities.
- Support the development and execution of FATs, SATs, DQ, IQ, OQ, PQ, and other relevant life cycle documents leveraged to support validation effort.
- Support the development and update of validation master plans, validation project plans, SOPs, risk assessments, user requirements, cleaning assessments, technical assessment reports.
- Support cleaning and sterilization (including CIP / SIP, manual cleaning, steam sterilization) development activities.
- Support periodic requalification and revalidation effort.
- Work independently and directly interface with personnel from multiple departments including Technical Development, Manufacturing, Engineering, Manufacturing Support, MAC, QC, and QA.
- Support gap assessment / closure, corrective actions, and compliance remediation related to Validation.
- As needed represent Validation as SME (Subject Matter Expert) during regulatory or customer inspections.
- As assigned mentor and manage fulltime validation engineers / specialist and contractors.
Education and / or Experience :
