Engineer III, Process CIP

• Develop test plans and protocols for commissioning and validation.
• Lead commissioning within assigned areas, including equipment inspections, field verification walk-downs and commissioning test execution.
• Provide equipment and system mechanical completion walk-downs, safety walk-downs, system energization plans, lock-out tag-out, and review and approval of equipment installation manuals (EIM).
• Prepare regular status updates for reporting progress, issues, safety, quality etc. to project management.
• Provide process engineering input during design development, construction, testing, commissioning and validation, and help manage changes through the project.
• Review and approve process engineering specifications, including process piping & instrumentation diagrams (P&IDs), datasheets, and procurement packages for new equipment and systems.
• Review and approve equipment vendor submittals, including system piping layouts, general arrangements and other equipment specifications and drawings.
• Lead the turnover of systems for subsequent validation activities and provide technical support throughout validation activities.
• Understand and implement internal policies, procedures and specifications as required for the execution of process engineering for the project.
• Interface with stakeholders to ensure the design, execution and delivery are in accordance with Global Engineering, Quality, Environmental and Safety procedures.
• A first strong experience in engineering, construction, commissioning and validation in a GMP/ pharmaceutical / biotech manufacturing environment, or an equivalent combination of education and experience
• A first experience in working with Automation

This position will be responsible for process engineering work packages during the design, construction and startup of a new green-field, large scale manufacturing facility. Responsibilities will include supporting the design development, procurement, factory acceptance testing, installation, commissioning and qualification of new process systems and equipment utilized in the production of biopharmaceutical drug substance.