Process Engineer (12-Month Contract | Hybrid)

Position Summary

ProQuality Network is seeking a Process Engineer to support manufacturing operations within a regulated pharmaceutical/biotech environment. Under general supervision, this role will provide technical support for process optimization, troubleshooting, and operational improvements across manufacturing, pilot plant, and capital project environments.

The Process Engineer will apply engineering principles to support system modifications, experiments, validation activities, and process improvements while ensuring compliance with GMP and operational requirements. The ideal candidate will have experience or exposure to Fermentation, Cell Culture, or Harvest processes, with preference for candidates who have supported commercial manufacturing campaigns.

This is a hybrid position, operating under an administrative schedule, for an initial 12-month contract assignment.

Key Responsibilities

• Provide technical support and engineering solutions for operational issues of moderate scope and complexity.
• Support process optimization initiatives and troubleshooting activities in manufacturing and operational environments.
• Evaluate and apply standard engineering techniques and procedures to support process improvements and system modifications.
• Execute routine technical assignments with clear objectives and analyze operational or engineering data for decision-making.
• Function as a technical resource for equipment and systems troubleshooting, supporting daily operations as required to meet schedules or resolve issues.
• Audit operational performance and regulatory compliance of equipment and systems.
• Collaborate cross-functionally with Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, Validation, and Research teams to support process and system improvements.
• Support design, engineering, and implementation of equipment modifications and capital projects under project management guidance.
• Assist in vendor coordination, equipment modification assessments, and installation activities.
• Support development of technical reports, engineering documentation, and validation-related documents.
• Participate in protocol execution and validation activities as required.
• Generate basic project schedules and cost estimates for engineering-related activities.

Minimum Qualifications

• Master’s degree in Engineering
• OR
• Bachelor’s degree in Engineering with at least 2 years of engineering experience

Preferred Qualifications

• Working knowledge of pharmaceutical or biotech manufacturing processes
• Experience or knowledge in Fermentation, Cell Culture, or Harvest processes
• Experience supporting commercial manufacturing campaigns preferred
• Familiarity with validation lifecycle activities and protocol execution
• Experience working in regulated environments (GMP/GLP)
• Familiarity with engineering documentation and technical report writing
• Experience with equipment troubleshooting and process support
• Strong analytical and problem-solving skills
• Basic project management and scheduling skills
• Strong verbal and written communication skills
• Computer literacy and technical documentation skills
• Ability to manage change and adapt in fast-paced manufacturing environments

Key Competencies

• Process troubleshooting
• Operational support
• Validation protocol execution
• Technical report writing
• Equipment systems knowledge
• Engineering problem solving
• Data analysis
• Cross-functional collaboration
• Compliance mindset
• Continuous improvement

Location: Hybrid

Schedule: Administrative Shift

Duration: 12-Month Contract