Commissioning and Qualifications Specialist

Kelly; Wilson (NC); On-site; USD 85,000 - 120,000; Full time

Job summary

Kelly, in partnership with Johnson & Johnson, seeks a Commissioning and Qualifications Specialist to ensure regulatory compliance and adherence to cGMP across projects in the Wilson, NC area.

You will lead QA reviews of validation activities, collaborate with Operations, Engineering, and MSAT, and drive documentation accuracy for URS, IQ, OQ, PQ, and related reports.

Qualifications

• Bachelor’s degree in a scientific or engineering discipline is required.
• Minimum of two years of experience in a regulated industry.
• Knowledge of commissioning, qualification, and validation requirements for GMP processes.
• Experience with URS, IQ, OQ, PQ, FAT, SAT, and related validation activities.
• Strong written and verbal communication for validation and quality documents.

Responsibilities

• Ensure site validation program complies with regulatory and corporate requirements.
• Collaborate with qualification teams across project phases from design to implementation.
• Review and approve validation protocols, reports, SOPs, and work instructions.
• Provide QA oversight for CSV, C&Q activities, and regulatory compliance.
• Support development and implementation of C&Q plans aligned with timelines.
• Review documentation for regulatory submissions and quality management.

Skills

GxP compliance

CQCV lifecycle

cGMP knowledge

FDA/EMA guidance

Risk-based approach

Technical writing

Cross-functional collaboration

Project coordination

Education

Bachelor’s degree in science/engineering

Job description

Kelly, in partnership with Johnson & Johnson, is hiring a Commissioning and Qualifications Specialist

Description:

This position is responsible for ensuring compliance with regulatory requirements and company policies in accordance with current Good Manufacturing Practices (cGMP), Johnson & Johnson policies, and internal procedures.

Key Responsibilities include, but are not limited to:

• Ensure that the site validation program is developed and maintained in compliance with all applicable regulatory and corporate requirements and master plans.
• Work with applicable qualification teams, representing Quality Assurance throughout the requirements definition, design review, construction, qualification, and project implementation phases.
• Support documentation strategies, cleaning development and validation, and the implementation of related projects.
• Review and approve commissioning and qualification documentation, including User Requirements Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports; Standard Operating Procedures (SOPs); work instructions; and other technical documents.
• Review and approve validation protocols and reports, including analytical, cleaning, and process validation documentation.
• Provide quality oversight of C&Q, Computerized System Validation (CSV), and validation execution activities to ensure compliance with cGMP, FDA, EMA, and other applicable regulatory requirements.
• Support the development and implementation of C&Q and validation plans, ensuring alignment with project timelines, milestones, and deliverables.
• Perform QA reviews of system impact assessments and the categorization of equipment and utilities.
• Ensure compliance with company quality standards, including SOPs, work instructions, and quality policies.
• Act as the QA point of contact for deviations, Corrective and Preventive Actions (CAPAs), and change controls related to C&Q and validation activities.
• Provide recommendations for process improvements to enhance compliance, consistency, and efficiency in C&Q and validation activities.
• Review and approve Technology Transfer documents to ensure that they meet applicable regulatory and Johnson & Johnson requirements.
• Collaborate with cross-functional teams, including Operations, Engineering and Maintenance, Manufacturing, Manufacturing Science and Technology (MSAT), Quality Control (QC), and Validation, to address quality issues.
• Provide support and direction to departments regarding specific quality-system elements to ensure that business, quality, and compliance goals are met in accordance with Johnson & Johnson standards.
• Partner with other departments to ensure that compliance systems are implemented efficiently and effectively.
• Develop and implement processes, procedures, forms, work instructions, and tools related to compliance systems at the site.
• Support the administration of site nonconformance management, change control, and training systems, including the applicable Electronic Tracking System (ETS).
• Support documentation review through the evaluation and approval of documents related to regulatory submissions, SOPs, and quality management systems to ensure accuracy and compliance, as required.

Required Skills and Experience:

• Bachelor’s degree in a scientific or engineering discipline is required.
• Minimum of two years of experience working in a regulated industry.
• Knowledge of commissioning, qualification, and validation requirements for GMP processes and systems, including utilities such as Water for Injection (WFI), clean steam, process gases, HVAC, and SIP/CIP systems.
• Experience with process equipment such as refrigerators, freezers, Laminar Airflow (LAF) units, Biological Safety Cabinets (BSCs), autoclaves, isolators, bioreactors, ultrafiltration/diafiltration (UF/DF) systems, centrifuges, and chromatography systems.
• Strong understanding of cGMP requirements and applicable FDA, EMA, and ICH guidance, as well as ISPE Baseline Guides.
• Hands‑on experience with the qualification and validation lifecycle, including URS, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), IQ, OQ, and PQ.
• Experience with cleaning and process validation.
• Familiarity with ISPE guidelines, including GAMP 5, ASTM E2500, and validation lifecycle principles.
• Strong understanding of risk-based approaches to commissioning, qualification, and validation.
• Proficiency in technical writing for validation and quality documents.
• Strong communication and interpersonal skills, with the ability to collaborate effectively with cross‑functional teams.
• High level of integrity and a demonstrated commitment to ethical conduct and compliance with regulatory requirements.
• Proven ability to manage multiple priorities and work independently with minimal supervision.
• Detail‑oriented approach, with the ability to identify opportunities for process improvement.
• Proven ability to prioritize tasks and meet deadlines in a dynamic manufacturing environment.
• Ability to build and maintain strong, positive working relationships.
• Ability to work effectively in a team environment and interact with employees at all levels of the organization.

Preferred Skills and Experience:

• Experience in the biotherapeutic and/or pharmaceutical industry.