General Manager Project and Validation

Role Objective: A key objective of this role is to oversee entire project lifecycle, ensuring compliance with regulatory standards and company policies. This role involves leading validation activities, coordinating with various departments, and providing technical expertise to ensure successful project execution. Desired Candidate Profile:

• Degree in MSc/BE in mechanical engineering with 15-18 years of validation experience in FDA-regulated manufacturing environments. Strong communication skills, attention to detail and proficiency in computer skills are essential.
• Minimum of 15-20 years’ extensive experience in project management within the pharmaceutical industry, particularly in SVP/LVP production and BFS (Blow Fill Seal) facilities.
• Proven track record in executing projects from conception to commissioning, with a strong focus on quality, compliance, and timely delivery.
• Excellent leadership skills with the ability to coordinate internal and external stakeholders effectively.
• In-depth knowledge of project documentation, regulatory requirements, and GMP standards.
• Strong analytical and problem-solving skills, with the ability to anticipate and address project risks/issues.
• Experience in vendor management, contract negotiation, and procurement processes.
• Proficiency in project management tools and software.
• Exceptional communication and interpersonal skills.

• Lead the project phase of the System Life Cycle approach to qualification.
• Develop User/Functional Requirement Specifications (UR/FS), Verification Plans, and Commissioning protocols.
• Prepare specifications for purchasing materials or equipment.
• Execute commissioning and qualification protocols for GMP areas, utilities, and equipment.
• Oversee instrumentation qualification and retirement phase activities.

• Ensure compliance with regulations (e.g., ISO13485, EU Annex 1, FDA, HC, EMA) and company policies.
• Provide documentation support for document control, change control, and validation activities.
• Conduct Hazard Analysis, Failure Mode Effective Analysis (FMEA), and risk management.

• Analyze validation test data and identify system problems.
• Operate computer-assisted engineering equipment.
• Conduct temperature/humidity mapping studies and engineering experiments.
• Develop process flow diagrams, material specifications, and standard operating procedures.

• Work collaboratively with teams to meet company objectives.
• Coordinate validation testing with affected departments.
• Provide training on qualification protocols and standard operating procedures.
• Participate in problem-solving efforts and internal plant audits.

• Support process improvement teams and capital projects.
• Perform statistical analysis, including Process Capability Studies.
• Conduct Vendor Audits for critical processes.
• Stay updated on validation principles, industry trends, and technologies through training programs.

• Identify and engage with world-leading OEMs for project requirements.
• Finalize contractors, review construction drawings and handle quotations for material procurement.
• Ensure equipment safety and adherence to regulatory requirements.

• Anticipate and proactively address potential project risks and issues.
• Develop mitigation plans to minimize project disruptions.
• Drive agility in project delivery and continuous improvement.

• Control project timeline, budget, and quality to meet organizational objectives.
• Ensure projects are completed within budgetary constraints and regulatory guidelines.

• Coordinate with various departments and vendors for data collection and project integration.
• Prepare and approve User Requirement Specifications (URS) and Facility Layouts.
• Plan/schedule qualification activities and project execution.

• Strong understanding of the System Life Cycle approach to qualification.
• Proficiency in developing validation protocols and documentation.
• Knowledge of regulatory standards (FDA, ISO, etc.) and compliance requirements.
• Ability to analyze validation test data and propose resolutions.
• Technical expertise in engineering equipment and experiments.
• In-depth knowledge of SVP/LVP production and BFS facilities.

• Excellent communication skills for collaboration and documentation.
• Attention to detail and precision in following instructions.
• Proficiency in computer skills, including data entry and analysis.
• Ability to work as part of a team and coordinate validation activities effectively.
• Commitment to continuous improvement and staying updated on industry trends.