Job Summary:

The Validation Engineer is responsible for ensuring that critical process and equipment validations meet regulatory and quality standards, including developing and reviewing URS, performing equipment qualifications (IQ, OQ, PQ), and generating essential documentation. This role exists to maintain and enhance compliance within the manufacturing process, preventing delays and mitigating risks associated with deviations or audit findings. By guaranteeing robust validation practices, the Validation Engineer directly supports PolyPeptide’s commitment to delivering high-quality products on time.

Key Responsibilities:

1. Draft and Review User Requirement Specifications (URS): Develop and refine URS for new and existing process equipment, ensuring alignment with manufacturing needs and regulatory standards.
2. Perform Equipment Qualifications (IQ, OQ, PQ): Plan, execute, and document qualification protocols to verify equipment performance meets cGMP requirements and intended use.
3. Execute Process Validation and Cleaning Validation: Identify critical process parameters, establish validation protocols, and conduct cleaning validations to maintain product quality and regulatory compliance.
4. Generate and Maintain Validation Documentation: Prepare, review, and archive validation reports, SOPs, protocols, and related records to ensure clear traceability and audit readiness.
5. Troubleshoot and Investigate Deviations: Collaborate with cross-functional teams to diagnose equipment and process issues, implement corrective actions (CAPA), and address audit observations promptly.
6. Support Scale-Up and Technology Transfer Efforts: Work with manufacturing and development groups to optimize processes, facilitate seamless scale-up, and transfer validated methods across PolyPeptide sites.
7. Coordinate with Cross-Functional Teams: Engage Quality, Process Development, and Manufacturing teams to meet project timelines, drive continuous improvement, and uphold cGMP standards.

Qualifications:

Education & Experience

• Required Education: Bachelor’s degree in engineering, Chemistry, or a related scientific discipline.
• Preferred Education: Certifications related to GMP compliance, quality systems, or validation.
• Experience:
  • Early-career experience (1–3 years) in validation engineering or a closely related field within a cGMP-regulated pharmaceutical or biotech environment.
  • Foundational understanding of process validation, equipment qualification (IQ/OQ/PQ), and pharmaceutical manufacturing processes.

Skills & Competencies

Technical Skills:

• Working knowledge of process validation and equipment qualification within a cGMP framework.
• Proficiency in drafting and reviewing validation documents (URS, SOPs, protocols, reports).
• Familiarity with deviation investigations, CAPA processes, and audit responses.
• Basic vendor management skills to evaluate and coordinate with external equipment/service providers.
• Competence in using data analysis tools and MS Office applications to track and report validation results.

Soft Skills:

• Strong problem-solving and analytical abilities to identify and troubleshoot process and equipment issues.
• Excellent communication skills for collaboration with cross-functional teams (e.g., Quality, Manufacturing, Process Development).
• Detail-oriented mindset with a commitment to maintaining compliance and documentation accuracy.
• Ability to manage multiple tasks and projects under tight deadlines while ensuring quality and regulatory standards.

Work Environment & Physical Demands:

Physical Requirements:

• Ability to work on the production floor and in laboratory settings, which may involve standing or walking for extended periods.
• Capacity to lift or move light-to-moderate equipment or materials when necessary (in accordance with safety guidelines).

Work Environment:

• Main work setting is an office environment with regular coordination of validation activities.
• Occasionally in cGMP-compliant manufacturing and lab environment requiring Personal Protective Equipment (PPE).
• May involve occasional cleanroom work with strict gowning requirements.
• Collaborative setting with cross-functional teams, balancing office-based tasks (documentation, analysis) and hands-on activities.

Performance Metrics (KPIs):

1. On-Time Validation Deliverables:
2. Complete validation projects (IQ, OQ, PQ, cleaning validation) within designated timelines, achieving a target of [e.g., 95%] on-time completion.
3. Compliance Rate:
4. Maintain [e.g., 98%+] adherence to cGMP standards, evidenced by minimal deviations or findings during internal and external audits.
5. Deviation/CAPA Closure Efficiency:
6. Address and close deviations, audit observations, and CAPAs within [e.g., 30 days] of identification, ensuring timely resolution.
7. Documentation Accuracy:
8. Achieve 100% accuracy in validation documentation (URS, protocols, SOPs, reports) with no major discrepancies identified during audits.
9. Vendor Management Effectiveness:
10. Evaluate and coordinate with equipment/service vendors to meet project requirements, achieving a [e.g., 95%] on-time and within-budget vendor performance rate.

Salary: $98k-$112k per year

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.