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Title: Operations Validation Engineer
Location: Boudry, Switzerland
Rate: Open
Openings: 1 Engineer
Contract/Perm: Contract (3-Months)
Join the team and be part of an innovative company that values inclusion, growth, and impact. Our dynamic work environment offers brilliant opportunities for advancement. ذكذكتسئµ is seeking talented and driven individuals who share our passion for making a difference within the Life Science industry.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
- The Engineer, Validation Operations performs validation and qualification activities. They assure compliance of these activities with cGMP as well as with internal policies and procedures.
- They are authorized to direct external vendors performing work in this field.
- In addition, the Engineer, Validation Operations is the backup of the Project Engineer And C&Q Supervisor for all Engineering and C&Q topics.
- May be assigned Qualification/Validation Lead role for a defined validation/qualification area.
- Develop and justify the validation approach based on risk and scientific rational.
- Ensure equipment and systems are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.
- Author and when required review qualification/validation documents, including requirement specifications, qualification/validation plans, protocols, reports, traceability matrix and summary reports.
- Execute qualifications/validations or manages people with the role of tester (including vendors) for all equipment and systems across the site, including QC, warehouse, facilities, lab equipment, utilities, and computer system validation, excluding global IT systems.
- Define and execute periodic activities maintaining qualified/Validated states of equipment, analytical instruments, utilities & facilities, and computerized system.
- Contributes to the development and maintenance of the local site procedures.
- Ensure the Validation strategy on site fit with global validation strategy in collaboration with global team.
- Lead risk assessments and risk management teamsReview/assess change controls and maintenance interventions, evaluating the impact upon qualified systems & validated processes, and documents required actions.
- Co-ordinate qualification and validation execution activities, including external vendors and internal departments.
- Supervision of internal and external resources dedicated for project.
- Leads new hire process for additional validation activities.
- Participate in internal and external audits as SME, by answering questions, reviewing qualifications and validations with auditors, and providing documentation.
- Establish and maintain effective relationships with internal team, customers, and suppliers.
- Contributes to continuous improvement, including proactively identifying problems and proposing solutions.
- Autonomous; completes work independently, seeking guidance on complex tasks and on non-routine decisions.
- Participates in projects and initiatives as directed by their leader
Key Skills and Requirements:
- BS/MS in Engineering/Technical discipline or equivalent experience
- 5 years' experience in pharmaceutical Validation
- Strong Knowledge with current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines and GAMP.
- Good ALCOA & Data Integrity knowledge
- Knowledge of pharmaceutical facilities (including HVAC and utilities), manufacturing and laboratory equipment/systems and computerized system validation (CSV)
- Communicates pro-actively and collaboratively.
- Proactively identifies problems and recommends solutions
- Team player: ability to interact effectively with team and customers.
- Good level of English
- Ability to communicate in French is preferred
If you are having difficulty in applying or if you have any questions, please contact Emile De Beer at e.debeer@proclinical.com.
Apply Now:
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
ذكذكتسئµ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ذكذكتسئµ is acting as an Employment Agency in relation to this vacancy.
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