Secondment with contracting
Food, Feed, Pharma
Over deze vacature
Do you have an academic or PhD degree in life sciences, chemical or bioprocess engineering or comparable level through experience and at least 6 years of experience in a validation role in the pharmaceutical industry? Are you driven to meet project targets and do you have strong project management skills? We would like to get in touch with you for the role of: Senior Process Engineer.
Welcome to our team
CoE Biotech Technical Operations in Oss provides process technological support to the local cell culture and purification facilities and involves 2nd line troubleshooting, process improvement projects and new product introductions. The work in BTO is highly multidisciplinary as it requires close collaboration with manufacturing operations (IPT), analytical laboratories, quality assurance, regulatory affairs and global technical groups (GES). The team consists of approximately 50 members, with expertise in a variety of topics like microbiology, cell culture, purification, engineering, small-scale laboratory operations and process and system validation.
The role as Process Engineer is a critical technical role within Technical Operations, ensuring systems used in the pharmaceutical production of biologics are in line with the GMP regulations. Specifically, he/ she will be responsible for supporting Upstream and Downstream manufacturing and providing expertise in (capital) projects on system design and execution, equipment user requirement specifications and process & facility fit assessments. The Process Engineer is does not have direct reports.
- Responsible for implementing the global guidelines and regulatory expectations in systems design (e.g. in URS, FDS, P&ID) and assure alignment with EHS requirements.
- Experience in engineering/process calculations for e.g. sizing of equipment and facility fit assessments;
- Creation of technical life cycle documentation required for qualification of equipment (e.g. IOPQ / pVMP)
- Be point of contact regarding GMP process systems design (facilities/utilities/equipment) for the Center of Practice - CoP and for the IPTs. E.g. participate in global peer groups and leading meetings with site SMEs.
- Participate as SME in Quality Risk Assessments related to design and use of GMP systems (e.g. on segregation requirements of material and people flows).
- Assess process, equipment, utility and/or facility changes for equipment qualification/validation impact.
- Expected to bring equipment and process design expertise and strong analytical and systematic problem-solving skills, supporting investigation teams in the event of system failures to identify root cause and corrective/preventive actions. And where needed, support the IPTs for the Impact Assessment for equipment deviations.
- Participate as SME during Pre-Approval Inspections, GMP inspections from Health Authorities and internal audits.
- Persuasiveness based on expertise and “science based” arguments
Our client, a multinational pharmaceutical company founded over 130 years ago, is mainly focused on medicines, vaccines, biologic therapies and the development of animal health products.
YER Technology offers you the possibility to join as Engineering Professional and to combine challenging assignments with extensive application and career guidance. The following conditions are applicable:
- Attractive salary according to the standards of our clients.
- 25 holidays per year and the option to buy more holidays.
- A temporary or permanent contract with YER.
- The possibility to join (y)our client directly after one year.
- Travel expense reimbursement.
- Good pension scheme according to STIPP.
- Every hour of overtime will be compensated.
- Open and transparent communication with your personal consultant.
- Free Dutch classes.
- Personal career coaching from our occupational psychologists.
- Broad technical and softs skills training opportunities.
- A Service Desk ready to answer all your practical questions.
- Academic degree in life sciences (Biotechnology or related) or comparable level through experience.
- Minimal 4 years experience as an engineer at a (biologics) pharmaceutical manufacturer.
- Engineering knowledge of systems used in the pharmaceutical industry.
- Engineering knowledge of pharmaceutical production/purification processes in USP and/or DSP.
- Demonstrated track record as a lead process engineer in cross-functional projects, leveraging both internal and/or external partners; supporting concurrent projects.
- “Go to Gemba” mentality.
- Knowledge of CGMP guidelines and regulatory expectations.
- Experienced in performing/reporting quality risk assessments (QRA) to support the design and use of systems and on segregation of production/equipment flows.
- Team player with the ability to work in a multidisciplinary setting.
- Strong collaboration skills within an empowered (project) team setting.
- Must demonstrate personal commitment concerning inclusion, working safely, healthy and environmentally friendly, and all other guidelines.
- Customer focused, process-oriented, and data-driven.
- Experience with lean problem-solving methodologies for continuous improvement of e.g. costs, quality, process robustness, standardization).
- Dutch (preferred) and English communication skills, verbally and written.