Commissioning and Qualification Engineer jobs in United States
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PharmEng Technology ยท 17 hours ago

Commissioning and Qualification Engineer

positionRaleigh, NC
timeContract
remoteOnsite
seniorityMid, Senior Level

PharmEng Technology is hiring Commissioning and Qualification Engineers to join their team in Raleigh, NC. These roles involve ensuring the successful commissioning and qualification of utilities and process equipment for pharmaceutical manufacturing projects, with responsibilities including leading C&Q activities and executing Factory Acceptance Testing.

ConsultingInformation TechnologyPharmaceutical
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H1B Sponsor Likelynote

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

CommissioningQualificationBlackClean utilitiesFATKneat softwareGMP understandingProblem-solvingOrganizational skillsCommunication skills

Required

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 problem-solving, organizational, and communication skills
Ability to work effectively in a fast-paced, team-oriented environment

Preferred

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

Benefits

Flexible employment options: Choose between full-time or contract roles.

Company

PharmEng Technology

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PharmEng Technology is a pharmaceutical company that provides consultancy services.
dateFounded in 1997
location
Toronto, Ontario, CAN
people-size201-500 employees
web-link
http://pharmeng.com

H1B Sponsorship

PharmEng Technology 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
2024 (3)
2023 (1)
2022 (1)

Funding

Current Stage
Growth Stage

Leadership Team

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Alan Kwong
Managing Director & CEO
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Company data provided by crunchbase