Commissioning and Qualification Engineer
Commissioning and Qualification Engineer
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Job Description
Commissioning and Qualification Engineer
Location: Raleigh NC
Job Type: Fulltime/Contract (Onsite)
Travel: Occasional travel may be required
We are hiring Commissioning and Qualification (C&Q) Engineers at both midlevel and senior levels to join our team in Raleigh NC. These roles involve ensuring the successful commissioning and qualification of utilities and process equipment for pharmaceutical manufacturing projects. Candidates should have experience in Black and Clean utilities process equipment support and FAT along with proficiency in Kneat software.
Key Responsibilities:
Commissioning and Qualification:
- Lead or support C&Q activities for pharmaceutical utilities and process equipment ensuring compliance with industry standards and regulatory requirements.
- Execute FAT (Factory Acceptance Testing) to validate equipment functionality and performance.
- Support the qualification of Black and Clean utilities such as water systems clean steam HVAC and gas utilities.
- Perform process equipment qualification to meet GMP and production readiness standards.
Documentation and Reporting:
- Develop and execute C&Q protocols including IQ OQ and PQ in alignment with project requirements.
- Utilize Kneat software to manage execute and document qualification activities.
- Maintain detailed and organized records of all commissioning and qualification activities.
Collaboration and Support:
- Work closely with crossfunctional teams including engineering validation and quality assurance.
- Troubleshoot and resolve issues encountered during commissioning and qualification phases.
- Ensure all activities adhere to FDA EMA and other applicable regulatory guidelines.
Continuous Improvement:
- Identify opportunities to optimize processes and incorporate best practices into C&Q activities.
- Leverage lessons learned to improve efficiency and project outcomes.
Qualifications:
- Bachelors degree in Engineering Life Sciences or a related field.
- Proven experience in commissioning and qualification in the pharmaceutical manufacturing industry.
- Expertise in Black and Clean utilities process equipment and FAT.
- Proficiency in Kneat software for C&Q activities.
- Strong understanding of GMP FDA and other regulatory requirements.
- Excellent problemsolving organizational and communication skills.
- Ability to work effectively in a fastpaced teamoriented environment.
SeniorLevel Additional Expectations:
- Demonstrated leadership experience in managing complex projects or teams.
- Ability to mentor and guide midlevel engineers.
- Extensive experience in highstakes commissioning and qualification projects.
Why Join Us
- Contribute to impactful pharmaceutical projects that prioritize innovation and quality.
- Work onsite in a dynamic environment with opportunities for professional growth.
- Flexible employment options: Choose between fulltime or contract roles.
Ready to advance your career in pharmaceutical manufacturing Apply today to join our expert team in Raleigh NC!
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Employment Type
Full Time
