Job Title: Commissioning, Qualification, and Validation (CQV) Engineer
Location: Zurich, Switzerland
Company Overview:
My client is a prominent pharmaceutical and biotechnology company situated in Zurich, Switzerland. They are committed to advancing healthcare through the development of cutting-edge medicines and therapies. Their dedication to excellence, safety, and efficacy sets them apart, and they are seeking a skilled Commissioning, Qualification, and Validation (CQV) Engineer to join their team.
Job Overview:
As a CQV Engineer at My client, you will play a pivotal role in ensuring the effective commissioning, qualification, and validation of equipment, systems, and processes within their pharmaceutical and biotechnology facilities. You will collaborate closely with cross-functional teams to ensure regulatory compliance, adhere to industry standards, and maintain the highest levels of quality in operations.
Key Responsibilities:
Commissioning:
- Develop and execute commissioning plans for new or modified equipment and systems, ensuring functionality and readiness for subsequent validation activities.
- Collaborate with engineering and project teams to verify that installed equipment meets design specifications and operational requirements.
- Conduct system walk-downs, functional testing, and performance verification activities during the commissioning phase.
Qualification:
- Develop and implement qualification protocols (IQ, OQ, PQ) for equipment, facilities, utilities, and computerized systems in compliance with regulatory guidelines and internal policies.
- Execute qualification protocols, collect and analyze data, and generate comprehensive reports to demonstrate compliance and validation success.
- Ensure that validation activities are conducted in a timely and efficient manner to support project timelines and product development.
Validation:
- Lead validation activities for manufacturing processes, analytical methods, cleaning, and other critical processes to ensure they meet predefined acceptance criteria.
- Work closely with cross-functional teams to assess risks, develop validation strategies, and execute validation protocols and reports.
- Provide technical expertise and support during regulatory inspections and audits related to validation activities.
Documentation and Compliance:
- Maintain accurate and comprehensive documentation related to commissioning, qualification, and validation activities in compliance with applicable regulations and company procedures.
- Review and approve validation documentation, change control records, and deviation reports to ensure compliance with established quality standards.
Qualifications:
- Bachelor's degree in Engineering or related field (Master's degree preferred).
- Minimum of 2 years of experience in commissioning, qualification, and validation within the pharmaceutical or biotechnology industry.
- Strong knowledge of relevant regulations, including GMP, GAMP, and FDA guidelines.
- Experience with equipment and automation systems commonly used in pharmaceutical manufacturing.
- Excellent written and verbal communication skills in English.
- Ability to work independently and collaboratively in a fast-paced, dynamic environment.
Join My client in Zurich, Switzerland, and be part of a team dedicated to revolutionizing healthcare and making a significant impact on global health through innovation, quality, and collaboration. They offer a competitive compensation package, opportunities for growth, and a stimulating work environment that encourages continuous learning and development. Apply today to contribute to their mission of improving lives and making a difference in the world.
Job Title: Commissioning, Qualification, and Validation (CQV) Engineer
Location: Zurich, Switzerland
Company Overview:
My client is a prominent pharmaceutical and biotechnology company situated in Zurich, Switzerland. They are committed to advancing healthcare through the development of cutting-edge medicines and therapies. Their dedication to excellence, safety, and efficacy sets them apart, and they are seeking a skilled Commissioning, Qualification, and Validation (CQV) Engineer to join their team.
Job Overview:
As a CQV Engineer at My client, you will play a pivotal role in ensuring the effective commissioning, qualification, and validation of equipment, systems, and processes within their pharmaceutical and biotechnology facilities. You will collaborate closely with cross-functional teams to ensure regulatory compliance, adhere to industry standards, and maintain the highest levels of quality in operations.
Key Responsibilities:
Commissioning:
- Develop and execute commissioning plans for new or modified equipment and systems, ensuring functionality and readiness for subsequent validation activities.
- Collaborate with engineering and project teams to verify that installed equipment meets design specifications and operational requirements.
- Conduct system walk-downs, functional testing, and performance verification activities during the commissioning phase.
Qualification:
- Develop and implement qualification protocols (IQ, OQ, PQ) for equipment, facilities, utilities, and computerized systems in compliance with regulatory guidelines and internal policies.
- Execute qualification protocols, collect and analyze data, and generate comprehensive reports to demonstrate compliance and validation success.
- Ensure that validation activities are conducted in a timely and efficient manner to support project timelines and product development.
Validation:
- Lead validation activities for manufacturing processes, analytical methods, cleaning, and other critical processes to ensure they meet predefined acceptance criteria.
- Work closely with cross-functional teams to assess risks, develop validation strategies, and execute validation protocols and reports.
- Provide technical expertise and support during regulatory inspections and audits related to validation activities.
Documentation and Compliance:
- Maintain accurate and comprehensive documentation related to commissioning, qualification, and validation activities in compliance with applicable regulations and company procedures.
- Review and approve validation documentation, change control records, and deviation reports to ensure compliance with established quality standards.
Qualifications:
- Bachelor's degree in Engineering or related field (Master's degree preferred).
- Minimum of 2 years of experience in commissioning, qualification, and validation within the pharmaceutical or biotechnology industry.
- Strong knowledge of relevant regulations, including GMP, GAMP, and FDA guidelines.
- Experience with equipment and automation systems commonly used in pharmaceutical manufacturing.
- Excellent written and verbal communication skills in English.
- Ability to work independently and collaboratively in a fast-paced, dynamic environment.
Join My client in Zurich, Switzerland, and be part of a team dedicated to revolutionizing healthcare and making a significant impact on global health through innovation, quality, and collaboration. They offer a competitive compensation package, opportunities for growth, and a stimulating work environment that encourages continuous learning and development. Apply today to contribute to their mission of improving lives and making a difference in the world.