PharmEng Technology
CQV Engineer - Downstream Process Equipment (Biopharma)
PharmEng Technology, Holly Springs, North Carolina, United States, 27540
CQV Engineer - Downstream Process Equipment (Biopharma)
Join to apply for the
CQV Engineer - Downstream Process Equipment (Biopharma)
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PharmEng Technology CQV Engineer - Downstream Process Equipment (Biopharma)
1 day ago Be among the first 25 applicants Join to apply for the
CQV Engineer - Downstream Process Equipment (Biopharma)
role at
PharmEng Technology Get AI-powered advice on this job and more exclusive features. About the job CQV Engineer - Downstream Process Equipment (Biopharma)
CQV Engineer - Downstream Process Equipment (Biopharma)
Employment Type:
Permanent/Contract (Fulltime)
We are seeking a skilled
CQV Engineer
to support commissioning and qualification activities for
downstream process equipment
within a large-scale biopharmaceutical manufacturing facility. This role involves hands-on work in a startup environment and collaboration with cross-functional teams to ensure timely, compliant, and successful delivery of equipment systems.
Key Responsibilities
Support commissioning and qualification of downstream process equipment, including chromatography skids and columns, column packing systems, UF/DF systems, filtration skids, product hold vessels, and intermediate bulk fill systems. Assist with the preparation and execution of CQV documentation, including Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Design Qualification (DQ), Requirements Trace Matrix (RTM), Quality Risk Assessments (QRA), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and final reports. Participate in system startup and handover activities, supporting the full CQV lifecycle from design through to operations readiness. Conduct field walkdowns, assist in punch list resolution, and verify mechanical completion of systems. Support Pre-Startup Safety Reviews and safe execution of startup activities. Ensure accurate documentation, traceability, and alignment with ASTM E2500 and project quality standards. Coordinate with scheduling and project teams to ensure proper sequencing and readiness of downstream process systems.
Qualifications:
Minimum 5 years of CQV experience in biopharmaceutical manufacturing environments, with a focus on downstream processing systems. Strong technical understanding of chromatography, UF/DF systems, filtration, and stainless-steel process equipment. Engineering background in Chemical or Mechanical disciplines preferred. Experience with DeltaV or similar process control systems, including troubleshooting and loop tuning. Familiarity with CQV documentation tools such as Kneat or equivalent. Proven ability to work collaboratively in cross-functional teams, including EPCM, automation, QA, and operations. Willingness and ability to travel as required for equipment acceptance testing and support.
Qualified candidates with a strong foundation in
downstream processing and equipment qualification
are encouraged to apply. This is an excellent opportunity to join a high-impact biopharma project and contribute meaningful expertise in a dynamic, fast-paced environment. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Engineering and Information Technology Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at PharmEng Technology by 2x Get notified about new Process Equipment Engineer jobs in
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#J-18808-Ljbffr
Join to apply for the
CQV Engineer - Downstream Process Equipment (Biopharma)
role at
PharmEng Technology CQV Engineer - Downstream Process Equipment (Biopharma)
1 day ago Be among the first 25 applicants Join to apply for the
CQV Engineer - Downstream Process Equipment (Biopharma)
role at
PharmEng Technology Get AI-powered advice on this job and more exclusive features. About the job CQV Engineer - Downstream Process Equipment (Biopharma)
CQV Engineer - Downstream Process Equipment (Biopharma)
Employment Type:
Permanent/Contract (Fulltime)
We are seeking a skilled
CQV Engineer
to support commissioning and qualification activities for
downstream process equipment
within a large-scale biopharmaceutical manufacturing facility. This role involves hands-on work in a startup environment and collaboration with cross-functional teams to ensure timely, compliant, and successful delivery of equipment systems.
Key Responsibilities
Support commissioning and qualification of downstream process equipment, including chromatography skids and columns, column packing systems, UF/DF systems, filtration skids, product hold vessels, and intermediate bulk fill systems. Assist with the preparation and execution of CQV documentation, including Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Design Qualification (DQ), Requirements Trace Matrix (RTM), Quality Risk Assessments (QRA), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and final reports. Participate in system startup and handover activities, supporting the full CQV lifecycle from design through to operations readiness. Conduct field walkdowns, assist in punch list resolution, and verify mechanical completion of systems. Support Pre-Startup Safety Reviews and safe execution of startup activities. Ensure accurate documentation, traceability, and alignment with ASTM E2500 and project quality standards. Coordinate with scheduling and project teams to ensure proper sequencing and readiness of downstream process systems.
Qualifications:
Minimum 5 years of CQV experience in biopharmaceutical manufacturing environments, with a focus on downstream processing systems. Strong technical understanding of chromatography, UF/DF systems, filtration, and stainless-steel process equipment. Engineering background in Chemical or Mechanical disciplines preferred. Experience with DeltaV or similar process control systems, including troubleshooting and loop tuning. Familiarity with CQV documentation tools such as Kneat or equivalent. Proven ability to work collaboratively in cross-functional teams, including EPCM, automation, QA, and operations. Willingness and ability to travel as required for equipment acceptance testing and support.
Qualified candidates with a strong foundation in
downstream processing and equipment qualification
are encouraged to apply. This is an excellent opportunity to join a high-impact biopharma project and contribute meaningful expertise in a dynamic, fast-paced environment. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Engineering and Information Technology Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at PharmEng Technology by 2x Get notified about new Process Equipment Engineer jobs in
Holly Springs, NC . Raleigh, NC $80,000.00-$90,000.00 3 days ago North Carolina, United States 3 weeks ago Raleigh, NC $85,000.00-$110,000.00 1 day ago Process Engineer II/III - Bulk Processing
Raleigh, NC $102,000.00-$184,000.00 3 days ago Water/Wastewater Process Engineer - #2719
Process Engineer II/III - Bulk Processing
North Carolina, United States 3 weeks ago Legal Process Engineer - Any Office Location
North Carolina, United States $60.00-$70.00 1 week ago North Carolina, United States $28.19-$46.99 1 week ago North Carolina, United States $28.19-$46.99 1 week ago Project Engineer High Purity Process Piping
North Carolina, United States $28.19-$46.99 1 week ago Senior Manufacturing Systems Engineer (Automation)
Durham, NC $101,000.00-$138,600.00 3 days ago 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