Cqv Lead

**PharmEng Technology** is a global ISO certified Pharmaceutical Compliance Consulting Firm with projects around the world providing quality services to the manufacturers of pharmaceutical and health care products for over 25 years.
- Our 300+ global consultants have expertise in Commissioning & Qualification, Validation, Quality Systems, Engineering, Medical Devices, Modular Cleanrooms, Thermal Mapping, Training, Toxicology and Regulatory Affairs.

**PharmEng Technology** is a cGMP compliant leader with international offices in Canada, Spain, France, Germany, Austria, Switzerland, Italy, Belgium, Singapore, Malaysia, Indonesia, Taiwan, Ireland, Denmark, Brazil and USA and maintains strategic partnerships for extended capabilities internationally.

**PharmEng Technology** is seeking full-time experienced CQV Lead **Switzerland**.
- Job Overview
- Experience in the **Pharmaceutical Companies** is required.
- Experience in **Blood Proteins** is a plus.
- English is mandatory, German is a plus.
- Will be expected to **lead the CQV team** for activities related to commissioning, qualification, requalification, and validation.
- Will be responsible to create the **Project CQV Strategy** with the different project leaders.
- Responsibilities
- Commissioning, qualification, and requalification of new or existing manufacturing and laboratory equipment, facilities, services, and systems following regulatory guidelines such as GMPs, EMEA, and FDA.
- Leading the corresponding qualification documents such as VP, IQ, OQ, PQ and PPQ protocols and reports, risk assessments, and development protocols.
- Providing support for the development of user requirements and functional specifications.
- Actively participating in all phases of validation projects in accordance with the client needed. Evaluating projects and providing technical information to others.
- Recommending to management as to the acceptance and release of qualified equipment/ facilities, services and/or systems.
- Supporting the generation and execution of all documentation related to demonstration batches, thermal studies, validation studies for equipment, engineering test runs, development studies.
- Reviewing technical and quality system documents such as SOPs, Change Control, Deviation Reports, and Batch Production Records, ensuring any document changes meet quality and validation requirements and are in full compliance with regulations, standards, and regulatory compliance issues.
- Providing technical assistance during investigations of process /equipment / cleaning / validation issues and aid in the resolution of validation deviations, protocol discrepancies and non-conformities.
- Providing effective solutions for the management of system deviations and non-conformities through the CAPA System.
- Qualifications
- Bachelor's degree in technical field (engineering, biology, chemistry, pharmacy).
- At least 10 years of experience in QA Oversight for C&Q activities, in Biopharma or Pharma industry.
- Generation and overview qualification documents like URS, System Risk Assessment, DQ, IQ, OQ, PQ, SOPs.
- Experience in Blood Proteins is a plus.
- Hands on commissioning, qualification and validation experience in the following disciplines is needed:

- o Facilities (including clean rooms, HVAC)
- o Utilities (including WFI / RO/ purified water, clean steam, clean air, compressed air and gases, process waste systems)
- o Major qualification equipment
- o Process and cleaning validation
- o Equipment qualification
- o Computer software validation
- Firm understanding of cGMP validation requirements / guidelines and familiarity with EMEA and FDA regulatory requirements for the Pharmaceutical/biopharmaceutical industry.
- Proven capability to assess processes, equipment, and products for sources of variation, ability to analyse data and reach appropriate conclusions, and to perform and appropriately document deviations and investigations.
- Experience with Microsoft Office Suite.
- Fluency in English is a must.
- German is a plus.
- Skills
- Good communication skills.
- Team Leader.
- Team player.
- Problem Solving Ability.
- Self-driven
- Attention to detail.
- Analytical Thinking.
- Stakeholder Management in a matrixed environment.
- What we offer
- Full-Time Position.
- Competitive Salary.
- Opportunities working for a global company.
- Continuous Professional Improvement including, but not limited to, courses or seminars.
- At **PharmEng Technology**, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our clients, and our community. **PharmEng Technology** is proud to be an equal opportunity workplace.