CQV Project Engineer Job at Stark Pharma Solutions Inc, California

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  • Stark Pharma Solutions Inc
  • California

Job Description

Position: CQV Project Engineer
Location: Los Angeles, CA (On-site)

Experience: 8 - 10 Years
Type: Contract

About the Role

We are seeking a motivated Project Engineer with 8 10 years of Commissioning, Qualification, and Validation (CQV) experience to join our client, a leading company in the life sciences sector. This role requires someone who thrives in a regulated, fast-paced environment and can balance technical execution with strong project coordination.

As a Project Engineer, you will manage day-to-day CQV activities, collaborate across multidisciplinary teams, and ensure projects are delivered on time, within budget, and in compliance with cGMP and regulatory standards. You'll be given autonomy to lead projects while having the support of a strong technical team.

Key Responsibilities
  • Plan, execute, and document CQV activities for process equipment, clean utilities, and support utilities.

  • Develop, review, and execute IQ/OQ/PQ protocols, commissioning reports, deviation reports, change controls, and summary reports.

  • Perform system testing to ensure compliance with cGMP and applicable regulations.

  • Maintain complete, audit-ready documentation across all CQV deliverables.

  • Manage project schedules, budgets, and milestones using project management tools (e.g., SmartSheet, MS Project).

  • Lead and support cross-functional teams, ensuring stakeholder alignment and satisfaction.

  • Facilitate project meetings, dashboards, reporting, and work breakdown structures.

  • Support both capital and expense projects from planning through execution.

Qualifications
  • 8+ years' experience in life sciences (pharmaceutical, biotech, or medical device) with at least 2 years in CQV .

  • Strong knowledge of IQ/OQ/PQ protocols and technical documentation.

  • Hands-on experience with process equipment, clean utilities, and support utilities.

  • Proficient in project management tools (SmartSheet, MS Project, or equivalent).

  • Excellent written and verbal communication skills in English.

  • Strong problem-solving, organizational, and relationship-building skills.

  • Ability to work independently and collaboratively within cross-functional teams.

  • Willingness to work fully on-site and flexibility for weekend/off-shift support when required.

Job Tags

Contract work, Shift work,

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