C&Q Specialist

Stark Pharma Solutions Inc; Indianapolis (IN); Sur place; USD 75 000 - 110 000; Plein temps

Résumé du poste

Stark Pharma Solutions Inc. in Indiana is seeking an experienced C&Q Specialist to support commissioning and qualification activities within a GMP-regulated pharmaceutical manufacturing environment.

You will execute C&Q for systems and equipment, develop IQ/OQ/PQ protocols, and review validation documentation to ensure GMP compliance.

Collaborating with cross-functional teams, you will support investigations and CAPA and help maintain validation lifecycle documentation.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• Experience in pharmaceutical or biotech C&Q/validation.
• Knowledge of IQ/OQ/PQ, GMP, GAMP 5, and validation lifecycle.
• Experience with qualification documentation and protocol execution.
• Strong troubleshooting and problem-solving skills.
• Excellent documentation, communication, and teamwork abilities.

Responsabilités

• 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.

Connaissances

IQ/OQ/PQ knowledge

GMP knowledge

Validation lifecycle

Troubleshooting skills

Documentation skills

Communication & teamwork

Formation

Bachelor's degree in Engineering, Life Sciences, or a related field

Description du poste

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

Job Overview

We are seeking an experienced C&Q Specialist to support commissioning and qualification activities within a GMP-regulated pharmaceutical manufacturing environment.

Key Responsibilities

• 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.

Required Qualifications

• 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.