Validation Engineer

Validation Engineer

The Validation Engineer manages and prioritizes all phases of assigned validation projects from initial concept through performance qualification and ongoing support of cGMP operations. This role ensures regulatory compliance by adhering to site and corporate validation plans, policies, and procedures, and contributes at a high level to Commissioning and Qualification as well as Computer Systems Validation in a biopharmaceutical and biotech environment.

Responsibilities:

• Manage and prioritize all phases of assigned validation projects from concept through performance qualification and ongoing support of cGMP operations.
• Ensure cGMP regulatory compliance by following site and corporate validation plans, policies, and procedures.
• Apply strong knowledge of validation practices and governmental regulations related to equipment, utility, facility, and computer system validations.
• Review and approve validation-related system lifecycle documentation, including user requirements, functional specifications, design specifications, commissioning protocols, qualification protocols, protocol deviations, and validation reports.
• Review data generated by validators for temperature mapping studies and ensure accuracy, completeness, and compliance.
• Write and execute validation protocols for equipment, processes, and computer systems, including IQ, OQ, and process validation activities.
• Lead and support equipment validation activities associated with manufacturing bulk drug substance in a single-use facility.
• Contribute subject matter expertise in Commissioning and Qualification and Computer Systems Validation (CSV), including software validation and related activities.
• Utilize validation-specific software programs and tools such as DeltaV, LIMS, and MES to support validation testing and documentation.
• Support continuous process improvement initiatives within bioprocess and manufacturing science and technology (MSAT) functions.
• Coordinate and prioritize multiple validation projects of varying complexity, ensuring timely completion and alignment with program goals.
• Collaborate effectively with cross-functional teams in biopharmaceutical, pharmaceutical, and biotech settings to support validation and compliance objectives.
• Prepare clear, accurate, and compliant technical documents and validation reports using strong technical writing skills.
• Apply knowledge of GxP regulations and current validation best practices to maintain robust and compliant validation programs.
• Demonstrate shared responsibility for safety by following established safety guidelines, procedures, and standard operating procedures in all validation activities.

Essential

Skills:

• Minimum of 5 years of experience in a biopharmaceutical or related environment focused on system qualification or validation.
• Bachelor of Science degree in Engineering, Science, or Project/Program Management.
• Experience validating equipment associated with manufacturing bulk drug substance in a single-use facility.
• Strong knowledge of validation practices and governmental regulations related to equipment, utility, facility, and computer system validations.
• Subject matter expertise in Commissioning and Qualification and Computer Systems Validation (CSV).
• Demonstrated ability to write and execute validation protocols, including IQ, OQ, and process validation activities.
• Proficiency in cGMP and GxP requirements within biopharmaceutical, pharmaceutical, and biotech environments.
• Highly effective verbal and written communication skills, including strong technical writing capabilities.
• Proficiency in Microsoft Office applications and validation-specific software programs.
• Ability to think and act both strategically and tactically in planning and executing validation projects.
• Proven ability to effectively prioritize and coordinate activities across multiple concurrent projects.
• Strong problem-solving and critical thinking skills with a demonstrated ability to conduct technical programs and achieve program goals.
• Strong organizational skills to manage and delegate multiple projects at differing levels of complexity.

Additional Skills &

Qualifications:

• Experience in biotechnology, biologics, and bioprocess operations within biopharmaceutical or CDMO settings.
• Experience in validation within pharmaceutical, biotech, and bioprocess manufacturing environments.
• Hands-on experience with validation testing, equipment validation, process validation, and computer system validation.
• Familiarity with software validation and CSV methodologies and standards.
• Experience using or supporting systems such as DeltaV, LIMS, and MES in a validated environment.
• Exposure to manufacturing science and technology (MSAT) and process improvement initiatives.
• Ability to collaborate with multidisciplinary scientific teams and support integrated discovery, development, and manufacturing services.
• Comfort working with clients and stakeholders in pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical…