Katalyst CRO · 6 months ago
Commissioning and Qualification Engineer
Raleigh, NC
Full-time
Onsite
Mid, Senior LevelKatalyst CRO is hiring Commissioning and Qualification Engineers to join their team in Raleigh, NC. The roles involve ensuring the successful commissioning and qualification of utilities and process equipment for pharmaceutical manufacturing projects, requiring expertise in Black and Clean utilities and proficiency in Kneat software.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
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
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
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
Identify opportunities to optimize processes and incorporate best practices into C&Q activities
Leverage lessons learned to improve efficiency and project outcomes
Qualification
Required
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
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
Company data provided by crunchbase