Commissioning & Qualification (C&Q) Specialist (North Region)

*Overview*

We are seeking a detail-oriented and experienced *Commissioning & Qualification (C&Q) Specialist* for a *5-month contract* to support our validation and compliance projects. The ideal candidate will have a strong background in validation and regulatory documentation within regulated industries, capable of developing and executing validation protocols and related documentation efficiently within a fixed timeline.

*Responsibilities*
* Generate comprehensive Validation Plans for systems and equipment
* Develop and maintain System Design Lifecycle (SDLC) documentation, including but not limited to: User Requirements Specifications (URS), System Risk Assessments, ERES CFR Part 11 compliance documentation, and GxP Assessments
* Develop, execute, and review Installation and Operational Qualification (IOQ) protocols
* Generate and approve protocol deviation reports as necessary
* Verify system drawings for accuracy and compliance
* Create and maintain Preventive Maintenance and Calibration forms, including training materials
* Develop Standard Operating Procedures (SOPs)
* Conduct Cleanability Assessments and document findings
* Prepare Final Summary Reports detailing validation outcomes and compliance status
* Collaborate with cross-functional teams to ensure project timelines and quality standards are met

*Skills*
* Proven experience in Validation Plan generation and execution
* Expertise in developing SDLC documentation such as URS, Risk Assessments, and compliance-related documents
* Knowledge of ERES CFR Part 11 and GxP guidelines
* Skilled in IOQ protocol development, execution, and deviation management
* Experience verifying technical system drawings and documentation
* Proficient in developing Preventive Maintenance and Calibration forms and related training
* Strong background in SOP development and Cleanability Assessment
* Ability to prepare detailed Final Summary Reports
* Excellent organizational, communication, and problem-solving skills
* Flexibility to work extended hours, weekends, and holidays as needed

*Preferred Qualifications*
* Experience in pharmaceutical, biotech, or medical device industries
* Familiarity with computerized system validation (CSV) practices
* Certification in validation or quality assurance is a plus

Job Types: Full-time, Contract

Pay: $24.00 - $28.00 per hour

Schedule:
* 8 hour shift
* Day shift
* Monday to Friday
* Overtime
* Weekends as needed

Work Location: In person