Cvq Head

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

**Discover Impactful Work**:
The position holder has several years of experience in CVQ (Commissioning, Verification and Qualification) activities, especially taking care of pharmaceutical project engineering and in qualification and validation topics and a good understanding of technical installations and pharmaceutical processes. You are familiar with innovative quality management tools and systems and you have expert knowledge in GMP. The role is in close contact with the local engineering, automation, manufacturing and quality department's leadership teams as well as with the maintenance & utilities teams to ensure a strategic alignment for all the CVQ activities.

**A day in the Life**:

- Leading and managing the CVQ team at the Lengnau site, taking ownership for all functions within CVQ
- Motivates and guides the CVQ team and addresses personnel issues as they arise immediately
- Ensures adequate resources for an efficient and reliable CVQ procedure and operation in alignment with the company strategy
- Ensure the sustainable technical operation for all new facilities, a cost-effective CVQ approach for different projects across the entire site
- Represents CVQ during GMP audits and inspections
- Establishes monthly department reports to Head P&S
- Encourages a culture of continuous improvement and development of technologies and procedures within CVQ
- Responsible for all CVQ activities at site for all the different projects
- Responsible for the development and continuous improvement in regards of compliance topics, establish work standards with current GMP and regulatory requirements in collaboration with the quality department
- Ensures the compliance with health, safety and environmental requirements within CVQ
- Exchange of information between the various departments and sites with qualification strategies and regarding all CVQ tasks and duties
- Continuous improvement of GMP compliant requalification and calibration systems based on current industrial principles and regulatory requirements
- Develop commissioning strategies to ensure GxP compliance of manufacturing and infrastructure systems in an efficient way
- Adheres to general safety rules, policies, procedures and instructions as rolled out by the EHSS functions and endorsed by the site management.
- Adheres to general cGMP rules, Quality policies, procedures and instruction as rolled out by the Quality function and endorsed by the site management

**Keys to Success**:
Education
- Bachelor’s degree or equivalent experience; educational concentration in pharmaceutical engineering, chemical engineering or equivalent

Experience
- Profound experience working in the pharmaceutical sector in a GMP environment
- Relevant qualification in a Quality field or relevant working experience within the are
- Experience of positively dealing with distractions or barriers to progress
- Ability to plan and prioritize with drive and determination - results orientated and able to meet deadlines
- Willingness to learn new skills and embrace procedures
- Effectively liaise with Engineering and QA at all staff levels

**Knowledge, Skills, Abilities**
- Excellent verbal and written communication skills in English and German
- Very good understanding of GMP guidelines
- Proven track record of dealing with Commissioning, Verification and Qualification
- Good understanding of technical installations and pharmaceutical processes
- Familiar with innovative quality management tools and systems

**What we offer**:

- Employment with an innovative, future-oriented organisation
- Outstanding career and development prospects
- Company pension scheme and other fringe benefits
- Exciting company culture which stands for integrity, intensity, involvement and innovation

At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disabil