CQV Engineer

Title: CQV Engineer Location: Ontario, Canada & Rensselaer, NY Employment Type: Contract (W2 / 1099) Duration: 12 Months About the Role We are seeking CQV Validation Engineers to support cycle development and qualification activities across multiple shifts in a GMP manufacturing environment. The selected consultants will work under the direction of shift leads, subject matter experts (SMEs), and project stakeholders to execute validation activities, support sterilization processes, and assist with troubleshooting during qualification efforts. Responsibilities Support cycle development and qualification activities across assigned shifts. Execute sterilizer qualification runs in accordance with approved protocols. Program and configure data loggers for validation activities. Place biological indicators (BIs) and data loggers within loads per protocol requirements. Download and analyze validation run data and process biological indicators. Support troubleshooting efforts and assist with deviation investigations. Collaborate with shift leads, SMEs, and cross-functional project teams to ensure successful qualification execution. Maintain accurate validation documentation and comply with GMP requirements. Required Qualifications Bachelor's degree in Engineering, Life Sciences, or a related technical discipline, or equivalent industry experience. Experience supporting Commissioning, Qualification, and Validation (CQV) activities in a GMP-regulated pharmaceutical or biotechnology environment. Hands-on experience executing sterilization or thermal validation protocols. Familiarity with biological indicators (BIs), data loggers, and qualification documentation. Strong troubleshooting, documentation, and communication skills. Ability to work assigned shifts and collaborate with cross-functional teams. Preferred Qualifications Experience with sterilizer qualification and thermal mapping. Knowledge of cGMP, FDA, and validation regulations. Experience supporting deviation investigations and root cause analysis. Equal Opportunity Employer We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Benefits This is a contract position and does not include employer-provided benefits. Background Check Background checks may be conducted in accordance with applicable laws. Work Authorization Applicants must be authorized to work in the United States.

Support cycle development and execute sterilizer qualification runs within a GMP manufacturing environment. Collaborate with cross-functional teams to troubleshoot deviations and maintain accurate validation documentation.

Requires a Bachelor's degree in Engineering or Life Sciences and experience with CQV activities in a pharmaceutical or biotech setting. Must have hands-on experience with thermal validation protocols and biological indicators.

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Commissioning, Qualification, and Validation (CQV)
• Sterilization Validation
• Thermal Mapping
• GMP Compliance
• Data Logger Configuration
• Biological Indicators
• Deviation Investigation
• Root Cause Analysis
• Protocol Execution
• Technical Documentation

• Engineering
• Manufacturing
• Science & Research
• Healthcare

Formation minimale

Baccalauréat

Expérience minimale

2+ ans

Postuler avant le

23 août 2026

Langue de l’offre

anglais

Heures de travail

40 heures par semaine

Niveau d’expérience

Mid-Senior level

Mode de candidature

La candidature directe est offerte