21 час назад
CQV Project Manager (Pharmaceutical)
115 000 - 140 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
CQV Project Manager (Pharmaceutical): Leading end-to-end commissioning, qualification, and validation activities for pharmaceutical manufacturing facility expansions and capital projects with an accent on GMP compliance, validation strategy, and project execution. Focus on developing URS documentation, managing FAT/SAT activities, coordinating vendors and stakeholders, and mitigating risks across the CQV lifecycle.
Location: Oceanside, United States; must be authorized to work in the US.
Salary: $115,000–$140,000 annually.
Company
Global consulting organization supporting pharmaceutical and life sciences clients with commissioning, qualification, and validation services.
What you will do
- Lead CQV activities across the full lifecycle of pharmaceutical capital projects.
- Develop and implement validation strategies for facility build-outs, expansions, upgrades, and capacity increases.
- Manage project planning, scheduling, budgets, risk mitigation, and execution.
- Coordinate cross-functional stakeholders, vendors, and contractors.
- Support manufacturing facility expansions, cleanroom projects, utility upgrades, and facility modifications.
- Maintain compliance with GMP requirements, regulatory guidelines, and product quality standards.
Requirements
- Bachelor’s degree in a related engineering discipline.
- 5+ years of experience managing end-to-end CQV activities for capital projects in GMP-compliant pharmaceutical production environments.
- Experience with URS development, FAT/SAT execution, and validation documentation.
- Experience managing facility expansions, production areas, cleanrooms, utilities, or facility modifications.
- Expertise in CQV risk-based approaches, project planning, stakeholder communication, and vendor coordination.
- US work authorization required; C2C arrangements are not available.
Culture & Benefits
- Medical, dental, and vision coverage, including full payment of qualifying employee medical premiums.
- Employee assistance, life insurance, and short- and long-term disability options.
- 401(k) plan with matching.
- PTO, sick time, and paid holidays.
- Education assistance, pet insurance, fitness discounts, and financial perks.
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