Teva Validation Engineer III 

United States, Pennsylvania, East Bradford Township 

999385132

The Validation Engineer III is responsible for ensuring the timely development, execution and approval of all validation programs and lifecycle documentation, (i.e. SOPs, Change Controls, CAPAs, Deviations), ensuring compliance with in-house specifications, standards and procedures, and implementing industry best practices.

The Validation Engineer III will lead, organize, and execute Validation activities to ensure completion of projects per schedule requirements. Also, contribute to the development of Validation Master Plans, Cleaning Validation Plans, and Computer Systems Validation Plans.

(Occasional travel to other global Teva or vendor sites may be required.)

• Support all aspects of the Validation Life Cycle from design through operation and improvements, and the revalidation program.
• Responsible for the preparation of site validation documentation (i.e. qualification protocols, validation master plans, risk assessments, and periodic reviews)
• Perform reviews of Validation documentation (i.e. protocols, summary reports, risk assessments, periodic reviews, and vendor validation documentation and summary reports.)
• Represent validation in multi-disciplinary teams focused on production facility build and laboratory move activities (working with commissioning, validation, and computerized system validation)
• Prepare reports using data from Process Validation, In-process Manufacturing testing In-process QC testing, and Finished Product QC testing.
• Create, maintain, and review Validation SOPs and ensure site aligns with corporate standards and cGMP guidelines
• Work with QA/Manufacturing group members to initiate and implement corrective and preventive actions
• Support internal/external audits and assessments and lead/support continuous improvement projects and activities.
• Provide support and training for Validation team members
• Attend regular/recurring meetings to support the production facility during campaigns and provide project status reports to Management

Required:

• Bachelor's degree or equivalent experience in life science, engineering or related discipline.

Preferred:

• At least 8 years of Validation experience in Biopharmaceutical products or combination of Validation and Engineering/Commissioning experience. (Knowledge in validation and quality compliance (cGMP/cGLP/ICH/FDA/USP/EU policies/guidelines.)

Additional Considerations:

The incumbent must be skilled in data integrity, manufacturing and laboratory equipment qualification, and GCP, GLP and cGMP regulatory procedures.

The Validation Engineer III must have thorough knowledge and experience with global regulatory requirements for Validation, including ERES (Part 11 and Annex 11) and current GAMP5 guidelines. The selected individual will be a key member of the R&D organization that owns and operates several cGxP laboratories and a manufacturing facility located at the West Chester campus.

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