4 дня назад
Program Manager – Engineering Projects (Biotechnology)
95 400 - 106 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Program Manager – Engineering Projects (Biotechnology): Planning and delivering facility, utility, and equipment projects that support clinical and commercial biopharmaceutical manufacturing with an accent on cGMP compliance, capital planning, construction, and equipment qualification. Focus on coordinating commissioning and validation activities, managing critical-path risks and budgets, and resolving technical issues through startup and GMP release.
Location: On site in Dunkirk, New York, United States. Monday–Friday during standard business hours, with flexibility subject to manager approval.
Annual base pay: $95,400–$106,000, plus discretionary bonus and equity award.
Company
is a publicly traded biotechnology company developing cell and immunotherapy products, vaccines, and next-generation treatments for cancer and infectious diseases.
What you will do
- Own end-to-end delivery of facility, utility, infrastructure, and equipment projects from concept design and funding approval through construction, commissioning, qualification, and handover.
- Build and maintain integrated program plans covering scope, milestones, resources, budgets, risks, dependencies, and critical-path activities.
- Coordinate internal teams, contractors, vendors, design partners, and commissioning and qualification providers.
- Partner with Facilities, Manufacturing, Quality, EHS, Engineering, Validation, Operations, and Supply Chain to deliver compliant facility layouts and building systems.
- Lead construction progress reviews, change-order evaluation, issue resolution, safety monitoring, and capital-spend tracking.
- Coordinate CQV deliverables, audits, inspections, technical troubleshooting, executive updates, and GMP release approvals.
Requirements
- Bachelor’s degree in engineering, science, or a relevant field.
- At least 3 years of engineering program or project management experience in biotechnology, pharmaceuticals, or another regulated life sciences manufacturing environment.
- Experience managing multiple projects and cross-functional teams in a matrixed organization.
- Knowledge of facility and utility systems, including clean utilities, process gases, HVAC, and process equipment.
- Working knowledge of commissioning and validation principles, including URS, design reviews, FAT/SAT, and IQ/OQ/PQ documentation.
- Proficiency with project management tools and Microsoft Office; ability to work in office, construction, and plant environments and lift up to 20 pounds.
Nice to have
- Experience with facility buildouts and equipment commissioning, qualification, and validation.
- Experience with capital or infrastructure projects involving construction, utilities, and equipment installation in cGMP environments.
- Experience with Waterfall and Agile or hybrid project management methodologies.
- PMP or another project management certification.
- Familiarity with CAD or BIM tools.
Culture & Benefits
- Collaborative environment with opportunities to work across different areas of the company.
- Professional development opportunities within a growing biopharmaceutical company.
- Medical, dental, and vision plan options, health and financial wellness programs, and an employee assistance program.
- 401(k) retirement plan with company match, flexible spending accounts, disability coverage, and life insurance options.
- Paid time off, including 11 holidays, with vacation and health-pay provisions based on employee classification.
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