Process/Project Engineer

Avecia Pharma; Milford (MA); On-site; USD 83,000 - 96,300; Full time

Job summary

Avecia Pharma in Milford, MA is seeking a Process/Project Engineer to provide engineering support for manufacturing and facilities. The role includes validation of equipment, troubleshooting, and managing small capital projects under $100,000, with emphasis on safety and continuous improvement.

You will work with cross-functional teams, create documentation, and ensure equipment operates reliably while supporting process improvements and regulatory compliance.

Qualifications

• B.S. in Chemical, Mechanical, or Electrical Engineering.
• GMP knowledge and FDA environment experience helpful.
• 0–5 years in manufacturing support.
• Hands-on startup and troubleshooting of equipment.
• Ability to work in cross-functional teams.

Responsibilities

• Support Manufacturing and Facilities operations.
• Create technical reports, URDs, CAD drawings, and SOPs.
• Develop and execute validation protocols.
• Maintain equipment operation through preventive maintenance.
• Provide on-call emergency support for equipment.
• Collaborate to investigate CAPAs and resolve issues.
• Drive Safety and Continuous Improvement initiatives.
• Coordinate small capital projects with cross-functional teams.

Skills

B.S. in Engineering

GMP knowledge

FDA experience

Equipment startup

Cross-functional teamwork

Education

B.S. in Chemical, Mechanical or Electrical Engineering

Job description

The Process/Project Engineer provides engineering support for manufacturing and facility related activities throughout the organization. Responsible for general engineering duties, including validation of equipment, support and troubleshooting of equipment / instruments, participation on client project teams, and support of Safety and Continuous Improvement efforts. The position is also responsible for specification and purchase of new process equipment and will manage small capital projects under $100,000.

Key Responsibilities

• Provide engineering support to Manufacturing and Facilities.
• Create Engineering documentation including technical reports, specifications, URDs, CAD drawings, and ETOPs.
• Develop and execute validation protocols.
• Create and revise equipment SOPs, preventive maintenance procedures and other documents needed to support equipment operation.
• Participate in client project teams as the Engineering representative.
• Responsible as a first line responder on equipment issues during manufacture which includes being available on-call for emergency support.
• Obtain general knowledge on process equipment.
• Train technical personnel in the use, care and safe operation of manufacturing/facilities assets.
• Collaborate with necessary departments to investigate and close CAPAs and resolve production problems.
• Participate in Safety and Continuous Improvement efforts to improve safety, efficiency and reduce cost.
• Coordinate small capital projects and work with internal cross-functional teams, vendors and contractors to ensure that projects remain on time and within budget.

Required Skills/Abilities

• B.S. Degree in Chemical, Mechanical or Electrical Engineering.
• Knowledge of pharmaceutical unit operations, general mechanical/electrical engineering concepts, process and equipment design, controls hardware/software, and an understanding of GMP regulations.
• 0 to 5 years of manufacturing support with preferred 2 years in an FDA regulated environment.
• Hands‑on ability to start‑up and troubleshoot of equipment
• Ability to contribute within cross‑functional teams

The annualized salary range for this position is between $83,000.00 - $96,300.00.