C&Q Specialist
Listed on 2026-10-12
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Quality Assurance - QA/QC
Quality Engineering -
Pharmaceutical
Pharma Engineer, Pharmaceutical Manufacturing, Quality Engineering
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: C&Q Specialist
Location: Indiana, USA
Duration: Long Term
We are seeking an experienced C&Q Specialist to support commissioning and qualification activities within a GMP-regulated pharmaceutical manufacturing environment
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- Execute Commissioning & Qualification (C&Q) activities for pharmaceutical manufacturing systems and equipment.
- Develop and execute IQ/OQ/PQ protocols and qualification documentation.
- Support qualification of equipment, utilities, facilities, and process systems.
- Review URS, FDS, risk assessments, SOPs, and validation documentation
. - Perform testing, troubleshoot deviations, and support investigations and CAPA activities.
- Ensure compliance with GMP, FDA, GAMP 5, and company validation procedures.
- Collaborate with Engineering, Quality, Manufacturing, Automation, and Validation teams.
- Support commissioning and qualification documentation throughout the validation lifecycle.
- Bachelor's degree in Engineering, Life Sciences, or a related field.
- Experience in pharmaceutical or biotech C&Q/validation
. - Strong knowledge of IQ/OQ/PQ, GMP, GAMP 5, and validation lifecycle
. - Experience with pharmaceutical manufacturing equipment, facilities, utilities, or process systems.
- Experience with qualification documentation and protocol execution.
- Strong troubleshooting and problem-solving skills.
- Excellent documentation, communication, and teamwork skills.
Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.
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