Senior Validation Engineer
Company: Hunter International Recruiting
Posted on: February 23, 2021
Senior Validation EngineerCompetitive Salary & Benefits Offered
Our client facility is seeking a Senior Validation Engineer who is
responsible for demonstrating hands-on experience in developing and
executing specifications, operating procedures,
commissioning/qualification/validation protocols and reports to
maintain "Systems" in validated state. Provide expertise for
projects involving sterile operation and process packaging
equipment as well as facility, utilities and computerized systems
(CSV) validation program. Senior Validation Engineer
- Demonstrate skills set, knowledge and apply ASTM E2500
principles, and good engineering practices to the Site Validation
- Author, review, and execute commissioning, qualification
(C&Q) and validation documentation.
- Maintain Equipment/Facility/Utility (EFU) and computer
validation program in accordance with Validation Master Plans and
- Ensure that C&Q and Validation project deliverables (i.e.,
Specification, SOPs; Protocols/Reports; Risk Assessment;
Tracebility Matrix, etc.) are compliant with the current
regulations, current industry practices, and internal policies and
- Execute and/or provide support with C&Q and validation
activities of cross functional teams including MS&T,
Engineering, Operations (sterile/non-sterile), and Quality as
- Author of valid systems' inventory to maintain periodic review
scheduling and revalidation program.
- Apply a science and risk-based approach for "Systems"
qualification activities to assess the need and/or extent of
required validation efforts.
- Generate and resolve qualification / validation protocol
discrepancies/deviations and/or other impact investigation
- Manage relationship with internal client group of operations,
ensuring Xellia CLE manufacturing & packaging equipment and its
processes are validated and in compliance for manufacturing.
- Can be responsible to define C&Q, Validation requirements
for technical transfer and/or new product/process introduction.
Senior Validation Engineer Requirements:
- Bachelor's degree in Engineering, Life Sciences, or related
discipline (Chemical Engineering, Chemistry, Biology, Electrical,
- A minimum of seven (7) years of hands-on, direct validation
experience in pharmaceutical / biotech industries.
- Champion to adopt / apply principles of ASTM E2500 (Standard
Guide for Specification, Design, and Verification of Pharmaceutical
and Biopharmaceutical Systems and Equipment).
- Recent and relevant to Sterilization Qualification, VHP
Decontamination processes experiences, including EFU, packaging
equipment and CSV validation.
- Knowledge in writing, reviewing and executing C&Q,
validation protocols and technical reports (including
- Experience in change control process.
- Working knowledge of applied risk assessment tools.
- Understand potential risk areas / shortfalls to deliver
validations right first time.Senior Validation Engineer Preferred
- Expertise with Isolator technology and sterile operations.
- Demonstrate ability to read, comprehend and interpret equipment
manuals, P&ID's, mechanical and electrical drawings and PLC
- Demonstrate skills in troubleshooting critical process or
- Proven mechanical aptitude preferred:
- Technology transfer / New Product/Process Introduction
- Process development / Process improvements (Design Of
- Knowledge in serialization / aggregation process and packaging
Keywords: Hunter International Recruiting, Akron , Senior Validation Engineer, Engineering , Akron, Ohio
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