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:

• Minimum Bachelor's Degree in Engineering or Science discipline, advanced degree is a plus.
• Minimum 5+ years of relevant validation experience in regulated industry. The engineer is expected to be proficient in at least 3 of 7 validation core expertise.
• Expertise in the following areas is must: Facility/Equipment/Utility Qualification, Cleaning/Sterilization Cycle Development, Cleaning Validation, computer system validation and Process Validation.
• Familiar with applicable domestic and international GMP regulations impacting validation requirements (e.g. 21 CFR 210,211,701,710,720,740, 820).
• Familiar with current industry guidance documents impacting validation best practices (e.g. FDA Process Validation guidance, ISO 13485, and applicable PDA Technical Reports).
• Experience with customer and regulatory inspection.
• Strong understanding of quality risk management principles, including best practice in risk-based C&Q approach.
• Hands on validation experience in developing validation documentation and field execution.
• Project Management experience is a plus.
• Aerosol production experience is a plus.