CQV Downstream Engineer

Stark Pharma Solutions Inc; Wilson (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Stark Pharma Solutions Inc. is seeking a CQV Downstream Engineer in North Carolina with 3+ years of experience in commissioning, qualification, and validation within pharmaceutical or biotech manufacturing. You will support downstream equipment, CQV documentation, and vendor activities.

You will review design documents, coordinate with Process Science teams, and ensure CQV activities align with GMP and project requirements. Equal opportunity employer seeking diverse candidates.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 3–5+ years of experience in CQV, validation, commissioning, or related roles.
• Pharmaceutical or biotech manufacturing experience.
• Experience with downstream processing equipment such as filtration, chromatography, buffers/media systems.
• Knowledge of GMP requirements and pharmaceutical validation practices.
• Familiarity with FDA, EMA, and GAMP guidelines.
• Experience with CQV documentation and qualification activities.
• Strong technical documentation, troubleshooting, and problem-solving skills.
• Good communication and teamwork skills.

Responsibilities

• Review engineering design documents, drawings, datasheets, specifications, and equipment lists.
• Support preparation and execution of CQV documentation for downstream systems.
• Support FAT, DQ, RTM, QRA, SAT, IOC, and IOQ activities.
• Prepare and support qualification and validation reports.
• Support development of downstream bridging documents.
• Coordinate with Process Science teams on process requirements, CPDs, and CQAs.
• Review vendor documentation and equipment packages.
• Support CQV activities for downstream manufacturing systems.
• Troubleshoot and resolve equipment and qualification-related issues.

Skills

CQV experience

Validation

GMP knowledge

Documentation skills

Communication

Teamwork

Education

Bachelor’s degree in Engineering or Life Sciences

Tools

Filtration equipment

Chromatography systems

Job description

About The Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

About The Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position: CQV Downstream Engineer

Location: North Carolina

Pay Rate: Long Term

Job Overview

We are seeking a CQV Downstream Engineer with 3 5+ years of experience in commissioning, qualification, and validation within pharmaceutical or biotech manufacturing environments. The role will support downstream equipment and systems, CQV documentation, equipment qualification, and vendor activities.

Key Responsibilities

• Review engineering design documents, drawings, datasheets, specifications, and equipment lists.
• Support preparation and execution of CQV documentation for downstream systems.
• Support FAT, DQ, RTM, QRA, SAT, IOC, and IOQ activities.
• Prepare and support qualification and validation reports.
• Support development of downstream bridging documents.
• Coordinate with Process Science teams on process requirements, CPDs, and CQAs.
• Review vendor documentation and equipment packages.
• Support CQV activities for downstream manufacturing systems.
• Troubleshoot and resolve equipment and qualification-related issues.
• Ensure activities comply with GMP and project requirements.

Required Qualifications

• Bachelor s degree in Engineering, Life Sciences, or a related field.
• 3 5+ years of experience in CQV, validation, commissioning, or related roles.
• Pharmaceutical or biotech manufacturing experience.
• Experience with downstream processing equipment such as filtration, chromatography, buffer/media systems, and process support equipment.
• Knowledge of GMP requirements and pharmaceutical validation practices.
• Familiarity with FDA, EMA, and GAMP guidelines.
• Experience with CQV documentation and qualification activities.
• Strong technical documentation, troubleshooting, and problem-solving skills.
• Good communication and teamwork skills.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.