Associate Director Validation & Engineering Compliancence

Position Overview:

The Assoc. Director, Validation & Engineering Compliance plays a critical role in ensuring compliance with GMP (Good Manufacturing Practices) and global regulatory requirements within a biotechnology environment. This role is responsible for reviewing and approving validation and engineering documentation, overseeing calibration and maintenance records, and maintaining data integrity processes to ensure product safety and regulatory compliance. The manager also collaborates with cross-functional teams, supports audits, and implements industry best practices to enhance operational efficiency.

Key Responsibilities:

Validation & Documentation Oversight

• Review and approve all validation documentation for biopharmaceutical manufacturing processes, ensuring compliance with FDA, EMA, and other global regulatory requirements.
• Oversee and approve Facility and Equipment (FE) Validation documentation.
• Installation Qualification (IQ) – Verification that equipment is installed per design specifications.
• Operational Qualification (OQ) – Testing of equipment functionality within specified operational limits.
• Performance Qualification (PQ) – Ensuring systems operate consistently under real-world conditions
• Protocols, discrepancies, summary reports, and periodic reviews to maintain validation status.
• Evaluate and approve vendor qualification documentation, ensuring that equipment and raw materials from suppliers meet biotech industry standards.
• Calibration, Maintenance, and Alarm Reviews
• Review and approve calibration records, preventive maintenance logs, and daily alarm reports to ensure the proper functioning of bioprocessing equipment.
• Environmental monitoring systems for temperature, humidity, and pressure differentials in cleanrooms.
• Ensure adherence to USP, ISO, and ICH guidelines for biotech manufacturing processes.

Data Integrity & Compliance

• Develop, implement, and maintain the Data Integrity Program to ensure compliance with:
• FDA 21 CFR Part 11 (Electronic Records & Electronic Signatures).
• EU Annex 11 (Computerized Systems in GMP).
• ICH Q9 & Q10 (Quality Risk Management & Pharmaceutical Quality Systems).
• Assess change control proposals, deviations, and Corrective and Preventive Actions (CAPAs) to maintain compliance and mitigate risks.
• Implement audit trails, user access controls, and electronic documentation systems to protect data integrity in biotech operations.

Leadership & Technical Expertise

• Act as a Subject Matter Expert (SME) for validation, engineering records, and data integrity, providing guidance to manufacturing, quality, and regulatory teams.
• Support regulatory inspections and client audits as the primary representative for validation records, engineering controls, and data integrity compliance.
• Mentor and lead a team of validation engineers and quality specialists, providing technical guidance on biotech validation challenges.
• Identify, implement, and standardize best practices in validation, engineering, and data integrity within the biotech industry.

Collaboration & Reporting

• Partner with Process Development, Manufacturing, and Quality Assurance teams to optimize validation processes for biologics production.
• Develop and present reports on validation performance metrics, data integrity trends, and compliance status to senior leadership.
• Contribute to continuous improvement initiatives, leveraging new technologies and regulatory trends to enhance biotech manufacturing operations.

Qualifications & Requirements:

• Education: Bachelor’s or Master’s degree in Biotechnology, Engineering, Life Sciences, or a related field.
• Experience: Minimum 5 years of validation and compliance experience in a biopharmaceutical or biotechnology manufacturing facility.

Technical Knowledge:

• Bioprocessing equipment validation (single-use systems, chromatography, sterile filtration, lyophilization)
• Automation & computerized systems validation (CSV) for biotech production
• Risk-based validation approaches (ASTM E2500, ISPE GAMP 5).

Skills:

• Excellent analytical, problem-solving, and leadership abilities.
• Strong understanding of regulatory expectations (FDA, EMA, ICH, ISO 13485 for medical biotech).
• Effective communicator with experience managing cross-functional teams and external vendors.