1. Support the development and execution of test plans and protocols for FAT, SAT, commissioning, qualification and validation. Oversee and or/lead commissioning within assigned areas, including equipment inspections, factory acceptance testing (FAT), site acceptance testing (SAT), field verification walk-downs and commissioning test execution. Oversee and/or lead equipment and system mechanical completion walk-downs, safety walk-downs, system energization plans, lock-out tag-out, and review and approval of turnover packages (TOP). Lead the turnover of systems for subsequent validation activities and provide technical support throughout validation activities.
2. Provide process engineering input during design development, construction, testing, commissioning, qualification 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.
3. Coordination with internal departments involved, other project stakeholders and suppliers. Develop relathionships with stakeholders to ensure the design, execution and delivery are aligned with stakeholder needs and expecations, and in accordance with Global Engineering, Quality, Environmental and Safety procedures.
Creating professional atmosphere by cooperation with peers within Process Engineering, building of knowledge system and coaching junior engineers.
4. Prepare regular status updates for reporting progress, issues, safety, quality etc. to project management.
5. Understand and implement internal policies, procedures and specifications as required for the execution of process engineering for the project.
Continuously develop and improve personal and professional skills by liaising with internal and external colleagues, (external) training and occasional visits of other Biogen plants.
English required, and fluency in German or French or Italian preferred.
Must have minimum of 2 years related experience in engineering, construction, commissioning and validation in a GMP / pharmaceutical / biotech manufacturing environment, or an equivalent combination of education and experience
Must be able to travel up to 20%, and up to 50% during the first year.
Priority placed on good communication and relationship skills.
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, qualification and validation of new process systems and equipment utilized in the production of biopharmaceutical drug substance. The initial focus of this position will be to drive the commissioning and validation effort by developing plans, writing test protocols and hands on field execution of commissioning and validation within specific process areas (cell culture, purification, process support), including assistance in training new manufacturing associates who will also support the commissioning and qualification activities.