10 дней назад
Exp Engineer - Process Engineering System Owner (Biologics)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Exp Engineer - Process Engineering System Owner (Biologics) (GMP biotherapeutics manufacturing): Leading delivery and technical ownership of process equipment systems from design through commissioning, qualification, and handover with an accent on equipment integration, construction execution, and GMP readiness. Focus on managing $10 million–$20 million equipment packages, resolving field and commissioning issues, and coordinating cross-functional delivery in a regulated manufacturing facility.
Location: Wilson, North Carolina, United States of America. Full-time onsite role with up to 10% domestic and international travel.
Company
Johnson & Johnson MedTech develops healthcare and innovative medicine solutions, including treatments and technologies designed to improve patient health.
What you will do
- Own the technical delivery and project management of process systems and equipment packages from design through turnover to end users.
- Lead engineering design and startup support for GMP biotherapeutics manufacturing facility systems.
- Manage approximately $10 million–$20 million in process equipment packages and field-installed scope.
- Coordinate vendors, construction teams, design partners, manufacturing, quality, commissioning, and qualification activities.
- Lead walkdowns, punch-list closure, commissioning and qualification protocol reviews, and system readiness approvals.
- Resolve commissioning issues, manage project changes, and support GMP readiness, qualification batches, audits, and final handover.
Requirements
- Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Bioprocess Engineering, or a related technical field.
- Minimum 5 years of process or plant engineering experience in commercial biologics manufacturing facilities.
- Experience with process engineering, plant engineering, equipment delivery, or manufacturing support in a GMP-regulated environment.
- Experience implementing new equipment from construction through commissioning, qualification, and turnover.
- Ability to lead or support cross-functional teams in a matrixed project environment while managing multiple priorities.
- Strong communication, collaboration, problem-solving, decision-making, and project execution skills.
Nice to have
- Master’s degree or MBA.
- Experience with large-scale monoclonal antibody production equipment, chromatography, tangential flow filtration, solution preparation and storage, autoclaves, washers, or clean-in-place systems.
- Experience with architecture and engineering firms, construction firms, and equipment vendors.
- Startup, commissioning, qualification, or GMP readiness experience for a new or expanded manufacturing facility.
- Professional Engineer or project management certification.
Culture & Benefits
- Inclusive work environment guided by the company’s Credo.
- Employee support covering wellness, career, and life needs.
- Work focused on developing medicines and healthcare solutions for patients.
- Equal opportunity employment and an interview process with accommodation support for applicants with disabilities.
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