Validation Engineer

Tri-Pac•South Bend, IN

About The Position

Validation Engineer Tri-Pac, Inc. a contract development and manufacturing company (CDMO) specializing in liquid and aerosol filling for personal care and pharmaceutical marketers, is seeking for a 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.

Requirements

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.

Nice To Haves

Project Management experience is a plus.
Aerosol production experience is a plus.

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.