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Senior Validation Engineer

Company: Tri Pac, Inc.
Location: South Bend
Posted on: November 15, 2019

Job Description:

Tri-Pac, Inc. a contract development and manufacturing company (CDMO) specializing in liquid and aerosol filling for pharmaceutical marketers, is seeking an experienced Senior Validation Engineer for immediate addition to our fast growing team. The position is in South Bend, Indiana.
Major Accountabilities:

  • Perform qualification of manufacturing equipment (liquid aseptic and aerosol aseptic), facility and utility systems (including CIP/SIP qualification), cleaning 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.

    Minimum Bachelor's Degree in Engineering or Science discipline, advanced degree is a plus

    • Minimum 7+ years of relevant validation experience in regulated industry. The engineer is expected to be proficient in at least 4 of 7 validation core expertise.
    • Expertise in the following areas is must: Facility/Equipment/Utility Qualification, Cleaning/Sterilization Cycle Development, Cleaning 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

      • Familiarity and demonstrated knowledge of biologics manufacturing processes, including fermentation, purification, and bulk filling processes.
      • Ability to work independently in a matrix team environment, influence team decisions, and exercise sound judgement in determining compliant and robust validation approach.
      • Ability to multi-task with demonstrated track records in meeting deliverable timelines.
      • Must demonstrate the ability to think critically and analytically with acumen for trouble-shooting and problem solving.
      • Good interpersonal skills, and accountable with excellent verbal and written communication skills.
      • Ability to function effectively and independently in a fast-paced and dynamic environment.
      • Self-motivated and willing to tackle assignments and development opportunities outside of job scope as needed.
      • Ability to interpret engineering and facility drawings such as facility layouts, blueprints, material/process flow diagrams, and equipment P&IDs.
      • Expert Microsoft Word / Powerpoint and Intermediate Microsoft Excel skills are required.
      • Understanding of basic statistics, acceptance sampling, and familiar with statistics software
      • Strong team player aligned with Grifols Corporate Values.
      • 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 is required.
      • Hands on experience with CIP/SIP cycle development and qualification is required

        Validation Core Expertise:
        • Facility Qualification
        • Equipment Qualification
        • Utilities Qualification
        • Cleaning Validation
        • Process Validation
        • Sterilization Validation
        • Computerized System Validation
          Benefits Competitive Salary & Packages, Vacations, Child Care, insurance reimbursement 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.
          Please Take a Moment To Visit Our Website
          Tri-Pac, Inc. is an Equal Employment Opportunity / Affirmative Action EmployerThank you for your interest and consideration of a career with Tri-Pac, Inc.

Keywords: Tri Pac, Inc., South Bend , Senior Validation Engineer, Engineering , South Bend, Indiana

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