Process Validation Engineer II

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Supply Chain Engineering

Process Engineering

Scientific/Technology

Raritan, New Jersey, United States of America

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We are searching for the best talent for a Process Validation Engineer II to join our Team! This is an onsite/hybrid role.

The Process Validation Engineer II will support and drive the initiative to establish a robust and sustainable continuous process validation program for the Lentiviral Vector and CAR‑T products leading up to commercial launch and through the life cycle of the program.

• Prepare well documented protocols and reports for all processes to be qualified/validated based on corporate/site guidelines, procedures, regulatory guidelines, and industry practices
• Coordinate and support the execution of validation activities with related departments and stakeholders (for example technical groups as Engineering, Manufacturing, Quality Control, Quality Assurance and others as applicable)
• Evaluate process/equipment performance during qualification/validation studies in order to determine acceptability, reproducibility, and control.
• Support investigations resulting from deviations associated with process validation activities and provides oversight of pre‑validation and validation activities resulting from technical changes.
• Propose and formalize alternatives for enhancement to qualification and validation processes and procedures in order to support process validation from a lifecycle perspective and ensure the program is sustainable.
• Support aseptic process validation from protocol generation, training execution, oversight, and reporting standpoint.
• Support equipment performance qualification and ensure consistency with process needs defined by Manufacturing or Tech Support.
• Support the Continuous Process Verification (CPV) plan with providing data review/assessment and periodic reports.
• Support the establishment of KPIs.
• Support APQ/APQR site reporting with data analysis and evaluation
• Provide technical assessments, rationales, and approval for engineering and process changes to meet regulatory requirements.
• Provide backup support to the Validation Manager and fellow engineers during absence.
• Assist management during internal and external regulatory audits.
• Support writing of Quality Risk Assessments for existing and new/changed processes

• A minimum of a Bachelors degree in a Scientific or related field is required
• A minimum of 2-4 years of professional relevant business experience.
• Experience with drafting and executing process validation protocols/reports is required
• GMP manufacturing and/or validation experience in pharmaceutical manufacturing is required.
• Familiarity with regulatory guidelines pertaining to process validation is required
• Excellent written and oral communication skill are required
• Open to up to 10% of travel.

• Cell and Gene…