Commissioning and Qualification Engineer

Job Description:
We are hiring Commissioning and Qualification (C&Q) Engineers at both mid-level 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.
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 cross-functional 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.

Requirements:

• Bachelor's 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 problem-solving, organizational, and communication skills.

• Ability to work effectively in a fast-paced, team-oriented environment.

Senior-Level Additional Expectations

• Demonstrated leadership experience in managing complex projects or teams.
• Ability to mentor and guide mid-level engineers.
• Extensive experience in high-stakes commissioning and qualification projects.