Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Engineering Compliance Specialist

Job Summary:

The Engineering Compliance Specialist plays a key role in ensuring that engineering activities align with regulatory standards, safety protocols, and company policies within the pharmaceutical industry. This position involves managing engineering-related deviations, supporting environmental, health, and safety (EHS) initiatives, overseeing change control processes, and ensuring adherence to engineering standards. The role also includes monitoring Key Performance Indicators (KPIs) to drive compliance, efficiency, and continuous improvement across all engineering functions.

Key Responsibilities:

Deviation Management:

• Act as the developer and owner of engineering-related deviations, ensuring timely investigation, root cause analysis, and implementation of corrective and preventive actions (CAPAs).
• Collaborate with cross-functional teams (quality, maintenance, and production) to resolve deviations in compliance with Good Manufacturing Practices (GMP).
• Maintain detailed records of all deviation investigations, ensuring documentation meets regulatory standards.

Change Control Management:

• Oversee engineering change control processes, ensuring changes to equipment, systems, and facilities are assessed, approved, and implemented in compliance with company and regulatory requirements.
• Facilitate risk assessments to evaluate the impact of proposed changes on product quality, safety, and compliance.
• Maintain and update change control documentation, ensuring alignment with internal policies and engineering standards.

EHS Compliance:

• Support Environmental, Health, and Safety (EHS) initiatives by ensuring engineering projects and operations comply with safety and environmental regulations.
• Identify and mitigate safety risks related to engineering processes, equipment, and systems.
• Conduct periodic EHS audits of engineering activities and equipment, ensuring adherence to safety protocols.
• Promote a culture of safety and environmental responsibility within the engineering team.

Engineering Standards:

• Develop, implement, and maintain engineering standards and procedures to ensure consistency, reliability, and compliance.
• Ensure equipment, systems, and processes are designed and maintained in accordance with pharmaceutical industry best practices and standards.
• Act as a subject matter expert (SME) on engineering standards during regulatory inspections and audits.

KPI Monitoring and Reporting:

• Establish, monitor, and analyze Key Performance Indicators (KPIs) for equipment reliability, maintenance performance, compliance, and efficiency.
• Provide regular reports and dashboards to highlight KPI trends, gaps, and opportunities for improvement.
• Drive continuous improvement initiatives to optimize engineering processes and ensure compliance with established KPIs.

Regulatory and Audit Support:

• Prepare for and support regulatory inspections and customer audits, ensuring audit readiness and providing documentation and data as required.
• Address and resolve any audit findings related to engineering compliance.

Qualifications and Skills:

• Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, or related field) or a similar discipline.
• Minimum 5 years of experience in engineering compliance within the pharmaceutical or biotech industry.
• In-depth knowledge of regulatory requirements, including FDA, EMA, and cGMP standards.

Technical Skills:

• Proficiency in managing deviation investigations, root cause analysis, and CAPA implementation.
• Experience with change control processes and risk management in engineering contexts.
• Familiarity with EHS standards and regulations.
• Knowledge of engineering systems, standards, and equipment reliability principles.

Preferred Qualifications:

• Experience with computerized maintenance management systems (e.g., Maximo or SAP).
• Certification in Lean Six Sigma or other continuous improvement methodologies.
• Familiarity with ISO 14001 and OSHA standards.