Katalyst CRO
Commissioning and Qualification Engineer
Katalyst CRO, Raleigh, North Carolina, United States, 27601
Commissioning and Qualification Engineer
Join to apply for the
Commissioning and Qualification Engineer
role at
Katalyst CRO Commissioning and Qualification Engineer
4 months ago Be among the first 25 applicants Join to apply for the
Commissioning and Qualification Engineer
role at
Katalyst CRO 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. Learning language lessons to improve efficiency and project outcomes.
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. Learning language lessons 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. Demonstrated leadership experience in managing complex projects or teams. Ability to mentor and guide mid-level engineers. Extensive experience in high-stake commissioning and qualification projects. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Commissioning and Qualification Engineer
Process Engineer 2 - Engineering Assurance # 4293
Consultant / Sr Consultant, CQV Engineering
Raleigh, NC $50,000.00-$240,000.00 4 days ago Durham, NC $59,951.00-$90,878.00 3 days ago Bridge Engineers (all levels – EI/EIT, PE, Sr-level/PM)
Durham, NC $84,000.00-$138,600.00 4 months ago Raleigh, NC $102,000.00-$184,000.00 2 months ago Raleigh-Durham-Chapel Hill Area $50.00-$60.00 2 weeks ago Wake County, NC $73,096.00-$100,000.00 2 weeks ago Holly Springs, NC $60.00-$80.00 6 days ago Project Engineer - Life Sciences/Advanced Manufacturing
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Join to apply for the
Commissioning and Qualification Engineer
role at
Katalyst CRO Commissioning and Qualification Engineer
4 months ago Be among the first 25 applicants Join to apply for the
Commissioning and Qualification Engineer
role at
Katalyst CRO 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. Learning language lessons to improve efficiency and project outcomes.
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. Learning language lessons 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. Demonstrated leadership experience in managing complex projects or teams. Ability to mentor and guide mid-level engineers. Extensive experience in high-stake commissioning and qualification projects. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Commissioning and Qualification Engineer
Process Engineer 2 - Engineering Assurance # 4293
Consultant / Sr Consultant, CQV Engineering
Raleigh, NC $50,000.00-$240,000.00 4 days ago Durham, NC $59,951.00-$90,878.00 3 days ago Bridge Engineers (all levels – EI/EIT, PE, Sr-level/PM)
Durham, NC $84,000.00-$138,600.00 4 months ago Raleigh, NC $102,000.00-$184,000.00 2 months ago Raleigh-Durham-Chapel Hill Area $50.00-$60.00 2 weeks ago Wake County, NC $73,096.00-$100,000.00 2 weeks ago Holly Springs, NC $60.00-$80.00 6 days ago Project Engineer - Life Sciences/Advanced Manufacturing
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr