- Company Name
- OmniaBio
- Job Title
- Associate I, Commissioning, Qualification and Validation (6-month contract)
- Job Description
-
**Job title**
Associate I, Commissioning, Qualification and Validation
**Role Summary**
Provide end‑to‑end support for commissioning, qualification and validation (CQV) activities in a GMP‑compliant biopharma environment. Develop and maintain validation master plans, deliverable documentation, SOPs, and support regulatory submissions, ensuring facilities, equipment, utilities and computer systems meet required standards.
**Expectations**
* Meet project schedules and deliverables in a fast‑paced, multi‑disciplinary setting.
* Communicate effectively with Manufacturing Science & Technology, Process Development, Operations, IT, and QA.
* Maintain meticulous documentation and audit readiness.
**Key Responsibilities**
* Draft and validate master plans and deliverable documents for equipment, facilities, utilities, and computerized systems.
* Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) plans and report results.
* Develop and maintain SOPs, preventive maintenance and calibration programs.
* Prepare temperature mapping protocols, alarm rationalization documentation and summary reports.
* Support deviation handling, change control, risk assessments, CAPA documentation and impact reviews.
* Perform periodic reviews of CQV documentation and SOPs.
* Function as a subject‑matter expert during internal audits.
* Report progress, qualification results and scheduling updates to the commissioning manager.
**Required Skills**
* 1+ year CQV experience in a biopharma or pharmaceutical GMP setting.
* Knowledge of clean‑room qualification, environmental monitoring, and related regulatory guidance (Health Canada, FDA, EMA, ICH Q7, GAMP 5, 21 CFR Part 11, ISPE, EU Annex, USP <1079>).
* Strong technical writing and documentation skills.
* Excellent analytical, problem‑solving and multitasking abilities.
* Effective written and verbal communication with cross‑functional teams.
* Integrity, resilience, and teamwork orientation.
**Required Education & Certifications**
* Post‑secondary education in engineering technology or a related field (preferred).
* No specific certifications required, though familiarity with CQV standards and regulatory frameworks is essential.