- Long - Term Interim Contract (3 years)
- High complexity project
Over onze klant
Leading international pharmaceutical company
- Lead the CQV project team for the capital program
- During the design and construction for the new facility responsible for:
- Managing the CQV Project team consisting of contracted resources and vendors to deliver the supporting deliverables for successful CQV
- Creating and managing the Validation Master Plan
- Develop a commissioning and qualification plan for the project
- Establish an integrated CQV schedule with construction completion and turnover and Process Validation activities
- Establish the resources necessary to execute the commissioning and qualification plans
- Prepare all CQV Plans and deliverables in support of CQV execution while working with construction and construction contractors and equipment vendors as necessary
- Establish and manage the budget to achieve a successful CQV program
- During Construction and through Commissioning and Qualification of the new facility responsible for:
- Execute the Commissioning plans in collaboration with the Construction manager and subcontractors
- Accountable for receipt of systems from Mechanical completion to completed Commissioning
- Execute the Qualification (Installation and Operational) plans
- Accountable for all systems qualification and turn over for Validation
- Prepare all supporting Turnover documentation
- Lead activities within the CQV project team responsible for cleaning validation, installation, operational and performance qualification (IQ/OQ/PQ) of process equipment, validation of SIP/CIP processes, validation of critical process equipment & utility systems and validation of process automation systems.
- Oversee validation execution for all engineering projects (small to large). Establish validation project plans commensurate with the level of risk and manage the execution of validation projects whose scope, regulatory visibility, schedule requirements, and complexity require coordination with customers, collaborators, and quality.
- Capable to act as a validation subject matter expert (SME), serving as necessary the primary point of contact to present validation philosophies and strategies to Health Authority inspectors and auditors.
- Works collaboratively with stakeholders such as Manufacturing, Site Engineering and Quality.
- Effectively manages assigned resources to address priorities, meet schedules, maximize productivity.
- Ensure alignment with directives and industry guidelines on validation.
- Develops and leads a high performance team responsible for CQ & V execution
- Knowledge of Engineering and Commissioning and Qualification activities related to large BioPharma capital programs.
- A minimum of 8+ years directly relevant experience in CQV of facilities and process equipment in a biologics drug substance manufacturing facility or similar BioPharma
- Direct experience with cleaning validation, critical utilities validation, cleaning validation, computer validation and temperature mapping concepts is required.
- Experience with Health Authority Inspections, External Auditors, Corporate and Internal Auditors
- A working understanding of lean principles is preferred. Excellent project management, communication, and technical writing skills are required.
- Demonstrated understanding of engineering documentation such as P and IDs, Process Flow diagrams and Standard Operating Procedures.
- Knowledge of regulatory validation requirements including FDA, EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8, and Q9) particularly as it applies to biologics manufacturing.
Proven ability working in a matrix environment and leading multi-level / cross functional teams to achieve the highest performance in meeting site and departmental objectives.
- Long term project
- Cutting edge technology
- Position is largely self directed