обновлено 4 дня назад
Lead Process Engineer (Biopharmaceutical Manufacturing)
120 000 - 160 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Lead Process Engineer (Biopharmaceutical Manufacturing): Leading the deployment of process equipment in GMP-regulated biopharmaceutical manufacturing, from planning and installation through commissioning, qualification, and operational handover with an accent on project leadership, equipment integration, and regulatory compliance. Focus on coordinating cross-functional stakeholders, resolving qualification and commissioning issues, and ensuring operational readiness for manufacturing startup.
Location: Onsite in Boston, Massachusetts, United States
Salary: $120,000–$160,000 annually
Company
Employee-owned international project delivery firm providing outsourced technical services across pharmaceutical, food, biotech, medical technology, and mission-critical sectors.
What you will do
- Lead process equipment implementation projects from planning through operational handover.
- Manage schedules, change controls, risk assessments, and cross-functional coordination.
- Oversee equipment delivery, installation, commissioning, startup, and punch-list resolution.
- Coordinate integration with automation, process control, digital systems, and computerized system validation teams.
- Lead qualification activities, discrepancy investigations, and lifecycle documentation.
- Coordinate training, EHS reviews, GMP release activities, and turnover to operations.
Requirements
- Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Bioprocess Engineering, or a related technical discipline.
- 8+ years of engineering experience in the pharmaceutical, biotechnology, or life sciences industry.
- Experience leading process equipment deployment projects in GMP manufacturing environments.
- Strong knowledge of commissioning, qualification, validation, and GMP compliance.
- Experience with single-use technologies, process equipment integration, and manufacturing operations.
- Strong project leadership, communication, problem-solving, and documentation skills.
Nice to have
- Experience with automation systems, process control systems, and computerized system validation.
- Knowledge of equipment lifecycle management, operational readiness, and manufacturing startup activities.
- Experience supporting capital projects in biopharmaceutical manufacturing.
Culture & Benefits
- Employee-owned organization with an inclusive culture focused on mutual respect and belonging.
- Commitment to sustainability and corporate responsibility.
- Reasonable accommodations are available for candidates with disabilities during recruitment.
- Base salary range reflects the expected annual compensation for the role.
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