CQV Engineer

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.