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Validation Engineer

Validation Engineer

Tri-Pac IncSouth Bend, IN, US
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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.

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.
  • Benefits Competitive Salary / Pay & Packages, Vacations, Insurance, 401K, Life Insurance, Disability (Long term / Short term) and Continuous Training.  Work where you are HAPPY!  Tri-Pac, Inc. also recognizes the importance of continuing education and offers Education Assistance to our employees to encourage continued personal development and growth. www.tri-pac.us Thank you for your interest and consideration of a career with Tri-Pac, Inc.

    • Tri-Pac, Inc. is an Equal Employment Opportunity / Affirmative Action Employer To Staffing & Recruitment Agencies :

  • Our Company does not accept unsolicited CV's or applications from agencies.
  • We are not responsible for any fees related to unsolicited CV's or applications and explicitly reserve its right to contact candidates presented in such unsolicited CV or application.
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    Validation Engineer • South Bend, IN, US