Our client, a rapidly growing pharmaceutical company with a unique mission, is looking to add a Validation Manager to their team. The Validation Manager will lead, support, and coordinate the work of the Validation team to ensure facilities, utilities, equipment and processes are qualified, maintained and calibrated properly on schedule complying to appropriate guidelines / specifications and internal procedures.
ESSENTIAL DUTIES AND RESPONSIBILITIES
The essential functions include, but are not limited to the following:
- Develop and implement validation policies and related procedures based on current regulations and industry standards in support of the company's growth and regulatory requirements.
- Provide oversight in the authoring and review of SOPs, protocols, reports and Validation Master Plans for cGMP equipment, cleaning, analytical methods, instruments, and computerized systems. In some cases, perform, author and review documents.
- Implement and manage cleaning & process validation programs including continued process verification.
- Understand and apply the understanding of FDA and Quality System Requirements in carrying out duties.
- Train end users on validation policies and requirements to support cGMPs.
- Evaluate all GMP Quality Systems utilizing Risk Assessment approach. Plan validation efforts according to risk.
- Lead Change Control and participate with Tech Transfer activities to ensure validation activities are identified to support new and existing client product and company processes.
- Mentor, coach, train and evaluate a team of junior and senior validation engineers. Lead hiring efforts for team growth and attrition.
- Effectively interact and collaborate with cross-functional departments and vendors in order to meet company expectations.
- Serve as subject matter expert in all aspects of validation.
- Establish and maintain continuous improvement projects in support of company activities and growth.
- Participate in regulatory inspections e.g. FDA, DEA inspections as a Subject Matter Expert (SME).
- Previous experience/best practices implementing and using continuous improvement/lean tools such as; Six Sigma, 5-S, Lean Manufacturing, Transactional Lean, etc.
- Demonstrates strong leadership, motivation, teambuilding, communication, and advanced coaching skills that instill a strong sense of mission in a team environment across all levels of organization.
- Demonstrates excellent planning and organizational skills, with the ability to balance production and maintenance needs.
- Knowledge of Computerized Systems Validation (CSV) experience and Part 11 compliance; ability to deliver and maintain a compliant validation program.
- Excellent project management and time management capabilities; with the ability to partner and influence across a matrixed environment. Excellent communication skills; verbal & written. Forecasts and adheres to departmental budget, and responsibly manages cost center resources.
BASIC QUALIFICATIONS (KNOWLEDGE, SKILLS, AND ABILITIES)
- A minimum of a bachelor’s degree is required. An advanced degree, such as an MBA, is desired.
- 10+ year’s progressive experience in manufacturing, operations management, or quality role at a pharmaceutical manufacturing / distribution facility, with at least 5 years of subject matter expertise with validation execution, program development or experience.
- A minimum of two years of experience as a primary SME with regulatory inspections is required.
- General knowledge of the pharmaceutical industry, brand and/or generics is preferred.
- Experience working in cGMP environments that meet FDA, EMA, ICH guidelines, local regulations, and industry best practices.
- Experience with regulatory inspections.
- Experience in sterile parenteral manufacturing.
- Ability to manage teams of varying education levels and cultural backgrounds to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches.
- Willingness to adapt to changing priorities as project demands change.
- Ability to explain complex technical issues to external customers / agencies.
- SME-level knowledge of high-speed aseptic filling and barrier system technology (isolator, RABS).
- Expertise in single-use components in drug product formulation, sterile filtration, and aseptic filling applications.
- Demonstrated management and delivery of large capital projects.
- Experience with greenfield facility Commissioning, Qualification, and Validation (CQV) and production startup desired.