Qualifications

• BS Engineering or relevant science degree required.
• 1-5 years of GMP process, equipment, and/or facility engineering validation experience.
• Preferred client-facing project management experience.
• Lean Six Sigma training/certification preferred.
• Proven ability to document and execute validation protocols compliant with cGDP and cGMP standards.
• Effective communication and collaboration skills, both written and verbal.
• Strong organizational, problem-solving, and decision-making abilities, capable of managing multiple priorities.

Responsibilities

• Develop User Requirement Specifications for new equipment and oversee vendor selection.
• Manage capital project budgets and timelines to ensure completion.
• Support Factory acceptance and Site acceptance tests as needed.
• Prepare and execute risk assessments, validation plans, and performance verifications.
• Author procedures and work instructions, and coordinate training for colleagues.
• Conduct periodic reviews and requalifications of equipment.
• Participate in continuous improvement initiatives and safety team activities.

Benefits

• Defined career path and annual performance reviews.
• Diverse and inclusive corporate culture.
• Positive work environment focused on innovation.
• Opportunities for career growth within a dedicated organization.
• 152 hours of PTO plus 8 paid holidays.
• Generous 401K match.
• Comprehensive medical, dental, and vision benefits from day one.
• Tuition reimbursement to support educational advancement.