Validation Engineer

Azzur Group; Philadelphia (Philadelphia County); On-site; USD 120,000 - 138,000; Full time

Job summary

A leading company in the life sciences sector seeks a Commissioning, Qualification, Validation Engineer (CQV) to ensure the successful commissioning and validation of critical systems. The ideal candidate will have expertise in qualifying various systems, including cleanroom equipment and lab instruments. This role demands strong problem-solving skills and the ability to work collaboratively in a dynamic environment. Join a culture that values personal responsibility and fun while contributing to impactful projects in the healthcare landscape.

Benefits

Health Care Plan (Medical, Dental & Vision)

Retirement Plan (401k)

Life Insurance (Basic, Voluntary & AD&D)

Paid Time Off (Vacation, Sick & Public Holidays)

Qualifications

• Proven experience in commissioning, qualification, and validation of QC Lab Equipment.
• Strong understanding of regulatory requirements including FDA, cGMP, and ISO standards.

Responsibilities

• Lead or support commissioning activities for cleanroom systems and equipment.
• Develop and execute qualification and validation protocols for QC Lab Equipment.
• Maintain comprehensive documentation of commissioning, qualification, and validation activities.

Skills

Problem-Solving

Communication

Interpersonal Skills

Education

Bachelor's degree in Engineering

Advanced degree preferred

Tools

HPLC

CTUs

Balances

BacT Alert

ViCell Blu

Job description

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Azzur Group is a GxP compliance and consulting organization focused on providing quality-driven solutions that propel life science companies toward success. If you're a dedicated professional with a desire to engage, learn, and adapt within a dynamic healthcare landscape, you will fit right into our core values: Put Others First, Have the Courage to Take Action, Take Personal Responsibility, and Have Fun!

As a Commissioning, Qualification, Validation Engineer (CQV), you will play a pivotal role in ensuring the successful commissioning, qualification, and validation of critical systems. Your expertise will be integral in qualifying systems such as Autoclaves, Glassware Washers, Clean Compressed Air, Clean Steam, Clean-in-Place (CIP), Water for Injection (WFI), Heating, Ventilation, and Air Conditioning (HVAC), and Plant Steam systems. In addition to Facility and Manufacturing equipment, a background in qualifying and validating Lab Equipment is essential for a CQV Engineer.

Commissioning:Lead or support commissioning activities for cleanroom systems and
equipment, ensuring proper installation and functionality according to design
specifications.
Qualification and Validation:Develop and execute qualification and validation
protocols for QC Lab Equipment (examples are HPLC, CTUs, Balances, BacT Alert,
ViCell Blu), cleanroom systems including autoclaves, glassware washers, and clean
utilities such as compressed air, steam, and water systems.
Documentation and Reporting:Maintain comprehensive documentation of
commissioning, qualification, and validation activities. Generate protocols, execute tests,
and prepare final reports ensuring compliance with regulatory requirements and company
standards.
Troubleshooting and Optimization:Identify and resolve technical issues during
commissioning and validation activities. Optimize system performance through
troubleshooting, root cause analysis, and process improvements.
Compliance Assurance:Ensure all commissioning and validation activities adhere to
regulatory requirements such as FDA, cGMP, and ISO standards. Stay abreast of
regulatory updates and industry best practices to maintain compliance.

Salary- Up to $120K

Azzur Group is a GxP compliance and consulting organization focused on providing quality-driven solutions that propel life science companies toward success. If you're a dedicated professional with a desire to engage, learn, and adapt within a dynamic healthcare landscape, you will fit right into our core values: Put Others First, Have the Courage to Take Action, Take Personal Responsibility, and Have Fun!

As a Commissioning, Qualification, Validation Engineer (CQV), you will play a pivotal role in ensuring the successful commissioning, qualification, and validation of critical systems. Your expertise will be integral in qualifying systems such as Autoclaves, Glassware Washers, Clean Compressed Air, Clean Steam, Clean-in-Place (CIP), Water for Injection (WFI), Heating, Ventilation, and Air Conditioning (HVAC), and Plant Steam systems. In addition to Facility and Manufacturing equipment, a background in qualifying and validating Lab Equipment is essential for a CQV Engineer.

Commissioning:Lead or support commissioning activities for cleanroom systems and
equipment, ensuring proper installation and functionality according to design
specifications.
Qualification and Validation:Develop and execute qualification and validation
protocols for QC Lab Equipment (examples are HPLC, CTUs, Balances, BacT Alert,
ViCell Blu), cleanroom systems including autoclaves, glassware washers, and clean
utilities such as compressed air, steam, and water systems.
Documentation and Reporting:Maintain comprehensive documentation of
commissioning, qualification, and validation activities. Generate protocols, execute tests,
and prepare final reports ensuring compliance with regulatory requirements and company
standards.
Troubleshooting and Optimization:Identify and resolve technical issues during
commissioning and validation activities. Optimize system performance through
troubleshooting, root cause analysis, and process improvements.
Compliance Assurance:Ensure all commissioning and validation activities adhere to
regulatory requirements such as FDA, cGMP, and ISO standards. Stay abreast of
regulatory updates and industry best practices to maintain compliance.

Salary- Up to $120K

Requirements

• Bachelor's degree in Engineering, Life Sciences, or related field. Advanced degree
  preferred.
• Proven experience in commissioning, qualification, and validation of QC Lab Equipment,
  cleanroom systems and equipment, in a biopharmaceutical or biotechnology
  environment.
• Strong understanding of regulatory requirements and guidelines including FDA, cGMP,
  ALCOA+, and ISO standards.
• Proficiency in developing and executing validation protocols, and protocols and
  documenting validation activities in a regulated environment and creating
  final protocol packages and final reports.
• Required technical expertise in QC Lab environments, cleanroom systems including
  autoclaves, glassware washers, clean utilities (compressed air, steam, water), HVAC, and
  steam systems.
• Analytical mindset with excellent problem-solving skills and attention to detail.
• Effective communication and interpersonal skills, with the ability to collaborate across

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)

Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Consulting

• Industries

  Pharmaceutical Manufacturing

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