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Mattson Resources
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http://www.mattsonresources.com
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USD
87000
114000
YEAR
true
Sean Goulding
Senior CQV Engineer
Posted: 04/18/2025
2025-04-18
2025-06-14
Employment Type:
Direct Hire
Industry: Engineering
Job Number: 20820
Pay Rate: $87,000 - $114,000
Job Description
We are searching for the best talent for Senior CQV (Commissioning, Qualification, and Validation) Engineer! This hybrid position will be located in Athens, Georgia!
The Senior CQV Engineer is responsible for supporting the qualification of cleanroom facilities and large process equipment at pharmaceutical manufacturing sites in Athens, GA. They will also be responsible for hands-on writing and executing of qualification protocols (IQ, OQ, PQ) and preparing final validation reports.
Key Responsibilities:
- Perform CQV activities for cleanroom areas and large process equipment, including but not limited to: Vessels (Bioreactors, Fermenters, Mixing Tanks); Centrifuges; Pharma Dryers; and/or CIP (Clean-in-Place) Skids.
- Develop, execute, and review Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
- Generate and maintain validation documentation, including final reports ensuring compliance with GMP, FDA, and industry standards.
- Work closely with engineering, quality, and operations teams to troubleshoot validation challenges and implement corrective actions.
- Support regulatory audits and inspections by providing validation documentation and justifications.
- Ensure compliance with cGMP, 21 CFR Part 11, ISPE Baseline Guides, and ASTM E2500 methodologies.
- Assist in risk assessments, change control evaluations, and impact assessments for equipment modifications.
QUALIFICATIONS:
EDUCATION:
- Minimum of a Bachelor's / University or equivalent degree in Engineering is required, preferably from an accredited college or university
EXPERIENCE AND SKILLS:
Required:
- Minimum of 2 years of relevant work experience
- Experience conducting commissioning, qualification, and/or validation
- Experience within one or more of the following industries: Biopharmaceutical, Pharmaceutical, and/or Medical Device
- Proven experience qualifying cleanroom areas and/or large-scale process equipment (e.g., vessels, centrifuges, filter presses, and/or CIP skids)
- Strong expertise in writing and executing validation protocols (IQ, OQ, PQ)
- Strong technical writing skills, including experience preparing final validation reports
- Working knowledge of GMP, FDA regulations, and industry best practices
- Familiarity with process automation, control systems (e.g., DeltaV, Rockwell, Siemens), and data integrity requirements
- Ability to work independently and collaborate with cross-functional teams
- Excellent problem-solving skills and attention to detail
Preferred:
- Experience with small molecule (chemical synthesis) pharma equipment validation
- Understanding of risk-based validation approaches (e.g., ASTM E2500, ISPE guidelines)
- Experience as SME for Health Authority Audits
- Knowledge of change control, deviation management, and/or CAPA processes within the Trackwise or COMET QEM systems
OTHER:
- May require up to 10% domestic travel
- Requires the ability, through our hybrid flexible work policy, to work on-site a minimum of three days each week, with the option for two remote workdays each week
Other Qualifications:
•Must be currently authorized to work in the USA, without the need for sponsorship (now or in the future).
•USA Domestic relocation may be available on a case-by-case basis, and at the discretion of the hiring leader.
The Senior CQV Engineer is responsible for supporting the qualification of cleanroom facilities and large process equipment at pharmaceutical manufacturing sites in Athens, GA. They will also be responsible for hands-on writing and executing of qualification protocols (IQ, OQ, PQ) and preparing final validation reports.
Key Responsibilities:
- Perform CQV activities for cleanroom areas and large process equipment, including but not limited to: Vessels (Bioreactors, Fermenters, Mixing Tanks); Centrifuges; Pharma Dryers; and/or CIP (Clean-in-Place) Skids.
- Develop, execute, and review Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
- Generate and maintain validation documentation, including final reports ensuring compliance with GMP, FDA, and industry standards.
- Work closely with engineering, quality, and operations teams to troubleshoot validation challenges and implement corrective actions.
- Support regulatory audits and inspections by providing validation documentation and justifications.
- Ensure compliance with cGMP, 21 CFR Part 11, ISPE Baseline Guides, and ASTM E2500 methodologies.
- Assist in risk assessments, change control evaluations, and impact assessments for equipment modifications.
QUALIFICATIONS:
EDUCATION:
- Minimum of a Bachelor's / University or equivalent degree in Engineering is required, preferably from an accredited college or university
EXPERIENCE AND SKILLS:
Required:
- Minimum of 2 years of relevant work experience
- Experience conducting commissioning, qualification, and/or validation
- Experience within one or more of the following industries: Biopharmaceutical, Pharmaceutical, and/or Medical Device
- Proven experience qualifying cleanroom areas and/or large-scale process equipment (e.g., vessels, centrifuges, filter presses, and/or CIP skids)
- Strong expertise in writing and executing validation protocols (IQ, OQ, PQ)
- Strong technical writing skills, including experience preparing final validation reports
- Working knowledge of GMP, FDA regulations, and industry best practices
- Familiarity with process automation, control systems (e.g., DeltaV, Rockwell, Siemens), and data integrity requirements
- Ability to work independently and collaborate with cross-functional teams
- Excellent problem-solving skills and attention to detail
Preferred:
- Experience with small molecule (chemical synthesis) pharma equipment validation
- Understanding of risk-based validation approaches (e.g., ASTM E2500, ISPE guidelines)
- Experience as SME for Health Authority Audits
- Knowledge of change control, deviation management, and/or CAPA processes within the Trackwise or COMET QEM systems
OTHER:
- May require up to 10% domestic travel
- Requires the ability, through our hybrid flexible work policy, to work on-site a minimum of three days each week, with the option for two remote workdays each week
Other Qualifications:
•Must be currently authorized to work in the USA, without the need for sponsorship (now or in the future).
•USA Domestic relocation may be available on a case-by-case basis, and at the discretion of the hiring leader.
Meet Your Recruiter
Sean Goulding
Vice President – Technical Recruiting, Skilled Labor, Accounting And Finance
Sean has over 8 years’ experience with Mattson Resources and over 20 years in executive search, technical recruiting, and staffing. With a Bachelor’s in Business Administration and a concentration in Human Resources as well as 16 years agency experience and 4 years corporate in staffing – Sean and his team can assist in all areas of search for your hiring needs. In agency search, Sean has led teams and recruiting services for Engineering, Sciences, IT, Skilled Labor, Operations, Supply Chain, Operational Excellence and more for Medical Device, Pharma, Aerospace, Automotive, Distribution, Transportation, IT Services, Software, Food & Beverage, Retail, and Consumer Products. In 2021 Sean oversaw Mattson Resources expansion and opening of a satellite office in Corona, CA.
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