MES Automation Consultant - Biopharma
A biopharmaceutical company is advertising a vacancy for an MES Automation Consultant to join their office in Switzerland. The organisation focuses on the discovery, development, and commercialisation of proprietary therapeutics used primarily in oncology. This is an exciting opportunity to work with a company that aims to become the international leader in the development and delivery of novel drugs for serious unmet medical needs.
- Acting as C&Q project manager for Process Control System (PCS) and Environmental Monitoring System (EMS).
- Working with the project team, the engineering companies, and the supplier on the detailed design deliverables concerning PCS/EMS systems requirements
- Reviewing and approving the relevant design documentation (URS, FDS, HDS, and SDS).
- Leading the risk assessment exercises (FMECA), the design qualification, and the traceability matrix concerning PCS/EMS systems.
- Reviewing, customising, and approving systems related documentation (supplying FAT/SAT protocols and reports, IQ/OQ Qualification protocols, and reports, deviations, and change controls) to ensure compliance with cGMP and applicable regulations.
- Supporting the Commissioning & Qualification activities (test execution or test witnessing).
- Performing quality audits for computerized and automated systems suppliers if needed.
- Working in view of the site readiness for regulatory inspections (Swissmedic and International).
- Contributing positively to a strong culture of business integrity and ethics.
- Acting within compliance and legal requirements as well as within company guidelines.
Skills and Requirements:
- Bachelor's Degree in relevant field such as Chemical Engineering, Bioengineering, Bioprocessing, Automation, or Engineering; an Advanced Degree is preferred.
- Strong experience of automation systems, specifically on qualification and validation activities.
- Must have a minimum of 10 years in an automation engineering role in a biopharmaceutical manufacturing environment.
- Thorough knowledge of biotechnological technologies, processes, with a demonstrated experience in computerized and automated systems (PCS/EMS).
- Demonstrable proficiency and experience in good practice requirements, GMP, as well as biopharmaceutical industry regulations and standards related to qualification and validation.
- Proficiency with the quality systems and, preferably, with business processes associated with the automation and integration of testing and production systems.
- Must speak English and French.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Will Hitchcock at +44 203 078 9554 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.