4 часа назад
Manager, Engineering (Biomanufacturing)
105 000 - 138 750$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Manager, Engineering (Biomanufacturing): Owning the operation, maintenance, reliability, and lifecycle management of a technical process and its PET/Facility assets at a regulated manufacturing site with an accent on GMP compliance, validation, automation, and equipment performance. Focus on leading engineering personnel, troubleshooting failures, driving root cause investigations and CAPAs, and supporting technical improvements and regulatory inspections.
Location: USA - OH - West Chester; onsite at the West Chester Manufacturing Site
Salary: $105,000–$138,750 per year
Company
is a technology-focused biomanufacturing company building a sustainable network of end-to-end manufacturing solutions.
What you will do
- Own the operation, maintenance, reliability, availability, and lifecycle management of a PET/Facility technical process and its assets.
- Schedule maintenance, coordinate technical resources, and provide troubleshooting support across all shifts.
- Lead engineering improvements, asset procurement inputs, project proposals, and technical investigations.
- Manage deviations, root cause analyses, impact assessments, and CAPA implementation after machine failures.
- Provide technical guidance, career development, and performance management for engineering and technical personnel.
- Author and review SOPs, batch records, material specifications, validation documents, change controls, and regulatory inspection materials.
Requirements
- Experience in a GMP or regulated production environment.
- Knowledge of FDA cGMP requirements.
- Previous supervisory experience and strong communication, leadership, and problem-solving skills.
- Expertise in at least two of the following: equipment, process/materials, maintenance, project delivery, automation and controls, or validation.
- Bachelor of Science in Engineering, Pharmacy, a related science, or business is preferred.
- Sponsorship or support for work authorization, including visas, is not available.
Culture & Benefits
- Annual cash bonus program and 401(k) plan with company match.
- Medical, dental, and vision coverage, life and disability insurance, and family-building benefits.
- Paid vacation, paid holidays, and other paid leaves of absence.
- Tuition reimbursement and support for caregiving needs.
- Equal employment opportunity and reasonable accommodation support throughout the hiring process.
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