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HEAD OF ENGINEERING AND VALIDATION
The Head of Engineering and Validation will define all user requirements and engineering standards for the manufacturing facility. The head will also build a team to define and execute the overall site validation program including facilities, utilities, and equipment. He or she will lead teams in the performance of validation activities such as Commissioning and Qualification, Performance Qualification (PQ)/Operational Qualification (OQ)/Cleaning Validation (CV)/ Process Validation (PV). The head will be responsible for selection and outsourcing of contractors to design and build the manufacturing facilities for Drug Substance and Drug Product production and packaging, including necessary infrastructure. The head will be responsible for budget and timeline management according to plan.
ENGINEERING RESPONSIBILITIES
- Design and directs manufacturing facility strategy and capital budgeting project in accordance with accordance with corporate strategic plan.
- Selects, directs and coordinates vendors & contractors to execute project implementation and completion per schedule and budget.
- Accountable for water & energy facility reliability and quality management and related site utilities optimization
- Define global site(s) engineering standards and procedures and related documentation system for the corporate engineering policy and SOPs. Ensures that all engineering documentation is updated and compliant with technical, quality and safety requirements.
- Manages change control for new implementation projects.
- Create site engineering master plan for expansion and improvement with capital cost plan.
- Direct EHS site program and implementation of safety measures in accordance with current regulations.
- Direct security operations for site.
VALIDATION RESPONSIBILITIES
- Develop and manage the detailed project plans and timelines for the execution of validation activities ensuring compliance with site engineering standards and regulatory requirements.
- Manage the qualification lifecycle of equipment and processes including design, installation, operational, performance, continuous qualification, and decommissioning.
- Manage projects and serve as technical lead for the introduction of new equipment and/or products within predetermined timelines, financial forecasts, and compliance requirements.
- Procure and manage external resources and materials to support validation deliverables.
- Oversight of validation change control management, deviation management, risk management for validated equipment, utilities, processes, and facilities.
- Prepare validation & change control documentation, including protocols, summary reports, etc., for validation activities.
- Lead presentation of the validation program and maintenance of the validated state during periodic audits and regulatory inspections.
- BS/MS in chemical, biochemical engineering, or related field/experience, with a minimum of 10 plus years’ experience in Biologic/Biotech manufacturing