In this position you will be responsible to define and support improvement activities of the manufacturing processes to ensure effectiveness, robustness, and compliance. In order to do this, you analyze data streams, define improvement opportunities and organize and execute the required production tests and validation runs. Based on your expertise, you support the improvement of processes while keeping focus on Prothya’s core results, i.e. Compliance, Delivery Reliability and Financial Strength.
Your job
In your position as CI Engineer, you will focus on technical aspects and quality aspects of improvement.
- In Technical Aspects
- Experience with and knowledge of equipment, principles and practices of preparative chromatography, column packing, centrifugation, and ultrafiltration/diafiltration (UF/DF), in a pharmaceutical environment.
- Experience with manufacturing equipment & auxiliary equipment such as tanks, process instrumentation, autoclaves, washers, clean utilities and CIP/SIP systems.
- Experience with process control and automation, implementing logics on PLC and SCADA is highly preferred.
- Support continuous improvement teams as per requirement.
- Experience with preparation of engineering documentation (e.g. URS, P&IDs), equipment installation, setting-up and start-up, commissioning FAT/SAT and IOQ and PQ and activities (equipment, process, automation and cleaning validation).
- Experienced in troubleshooting, root cause analysis, FMEAs, and Agile scrum.
- In Quality Aspects
- Broad understanding of cGMP.
- Experienced in handling change controls and CAPAs and experience with TrackWise.
- Understanding relevant International guidelines ISPE/ICH/FDA.
Your profile
- Bachelor’s degree, including relevant experience, in relevant study such as Pharmaceutical Engineering, Chemical Technology, Mechanical Engineering, (Bio) Process Technology or Biochemistry.
- Minimum of 3 years relevant work experience as a process engineer preferably at a pharmaceutical or biotechnological production company.
- Thorough GMP and validation knowledge and experience.
- Lean Six Sigma (green belt, black belt) is a nice to have.
- Strong quality awareness and familiar working with deliverables and deadlines.
- Self-starter and team player
- Experience as project team member.
- Fluent in English – oral & writing – is a necessity; including technical reports.
What we offer
We offer you a full-time job and a one-year contract to begin with. The following employment conditions apply:
- Full-time employment
- 8.33% end of year bonus and 8.33% holiday allowance
- Flexible working hours in consultation
- Personal training budget of €2,000 per 3 years
- Contribution to travel expenses from the first kilometer
- Good accessibility by public transport and private parking
- Pension plan at Zorg & Welzijn
More info
If you would like to know more about this vacancy, please contact our recruitment department via careers.nl@prothya.com. Do you recognize yourself in the profile and do you want to take on this challenge at Prothya Biosolutions? Then we would like to receive your resume and motivation letter via the apply button on this page. We aim to respond to you within a week.
