ALTRAN AG is looking for Commissioning Qualification Validation “CQV” engineer.
Performs cGMP compliance based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS’ clients. Follows IPS and client standards and requirements, overall good industry practices for C/Q/V services and regulatory requirements. May also perform standalone commissioning services for non-FDA regulated clients.
- You will join the Global leader in Engineering and R&D Services (ER&D), offers its clients a new way to innovate by developing the products and services of tomorrow.
- You will be working alongside its clients on every link in the value chain of their project, from conception to industrialization.
- Become part of the Group, which has provided its expertise for over 30 years to key players in the Aerospace, Automotive, Defense, Energy, Finance, Life Sciences, Railway, and IT/Telecoms sectors, among others.
- In 2016, the Altran group generated revenues of €2.120bn, including headcount of more than 30,000 employees and presence in more than 20 countries worldwide, in Switzerland with a strong presence in Zurich, Basel, Lausanne and Geneva.
- More info on the Group Vision IGNITION 2020: http://ignition.altran.com/en/altran2020-ignition
Commissioning & Validation Engineer - CQV
Write C/Q/V documents following established standards and templates, including but not limited to the following:
- Commissioning Forms “Commissioning / Qualification / Validation” C/Q/V
- Protocols and Summary Reports Standard Operating Procedures
- Impact Assessments Specifications
- Perform field/site activities including, but not limited to, the following:
- Attend and witness FATs and SATs as a representative of IPS clients.
- Execution of commissioning forms and witnessing of vendor start-up and testing.
- Execution of C/Q/V protocols.
- Walkdown and verification of system drawings (P&IDs, as-builts, etc.)
- Bachelor / Master / PhD Degree in Engineering ; Pharma : Biotech...
- 3/4 years up to 10 years of experience in Pharmaceutical, Biotech, Medical Device
- General exposure and experience in a GMP Quality environment / Validation discipline
- Knowledge and understanding of pharmaceutical Commission/Validate processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA.
- Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, etc.)
- English fluent, German is a plus
- A permanent contract with the leader in innovation and high-tech engineering consulting
- A multi-stage model with career opportunities through specialization prospects, as well as continuing professional education and training
- A steep learning curve due to diverse and cross-industrial project opportunities
- An open and constructive corporate culture with over 30,000 people in over 20 countries.
- Helping clients to realize ideas from ideation, prototyping, industrialization of products, manufacturing, scale-up, distribution as well as service provisioning / support
- Global projects & global job opportunities
Have we raised your interest? Are you taking initiatives? Do you like to work in a multidisciplinary team? We are looking forward to receiving your detailed application including motivational statement, copies of your degree as well as any work certificates through our online career portal. You can track your application status online at any time: tms.altran.com. Good luck!
Mr Maxime Kapps
Recruitment Manager Life Science