Lead Process Engineer (Biotech)

TL;DR

Lead Process Engineer (Biotech): Providing technical and project leadership for the deployment of process equipment within a GMP-regulated biopharmaceutical manufacturing environment with an accent on equipment integration, commissioning, and qualification. Focus on managing project schedules, ensuring regulatory compliance, and overseeing operational handover in the Greater Boston area.

Location: Onsite in the Greater Boston area, Massachusetts

Salary: $120,000 – $160,000 annually

Company

hirify.global is an employee-owned, international project delivery firm with over 50 years of experience, specializing in the pharma, biotech, and medical technology sectors.

What you will do

• Lead process equipment implementation projects from initial planning through to operational handover.
• Manage project schedules, change controls, risk assessments, and cross-functional coordination.
• Oversee equipment delivery, installation, commissioning, startup activities, and resolution of punch-list items.
• Coordinate integration activities with automation, process control, and computerized system validation (CSV) teams.
• Lead qualification activities, discrepancy investigations, and the development of lifecycle documentation.
• Ensure operational readiness through training coordination, EHS reviews, and GMP release activities.

Requirements

• Bachelor's degree in Chemical, Mechanical, or Bioprocess Engineering or a related technical discipline.
• Minimum 8+ years of engineering experience within the pharmaceutical, biotechnology, or life sciences industry.
• Proven experience leading process equipment deployment projects in GMP manufacturing environments.
• Strong knowledge of commissioning, qualification, validation, and GMP compliance requirements.
• Demonstrated project leadership skills with the ability to manage multiple stakeholders and priorities.
• Excellent communication, problem-solving, and documentation skills.

Nice to have

• Experience with automation systems, process control systems (PCS), and computerized system validation (CSV).
• Knowledge of equipment lifecycle management and manufacturing startup activities.
• Prior experience supporting capital projects in a biopharmaceutical manufacturing environment.

Culture & Benefits

• Employee-owned company culture focused on inclusivity and mutual respect.
• Commitment to sustainability and corporate responsibility as part of the 2026 business strategy.
• Supportive environment for professional growth and knowledge sharing across international offices.
• Reasonable accommodations provided for candidates with disabilities during the recruitment process.