Process Engineer

A qualified Process Engineer is needed to support recapitalization projects, Business Continuity Plan (BCP) initiatives, and general process engineering activities at a regulated manufacturing site. The resource will provide technical expertise in equipment design, installation, verification, and process engineering support, working closely with site engineering and operations teams.

This role requires strong knowledge of Asset Delivery (C&Q) processes, experience with Kneat, and the ability to support investigations, assessments, and problem-solving activities in a GMP environment.

Key Responsibilities

• Evaluate equipment requiring recapitalization or BCP planning and provide implementation recommendations.
• Develop documentation to support capital funding requests.
• Provide technical input during equipment design and procurement, including review of datasheets, design drawings, and specifications.
• Incorporate EHS considerations into proposals, design, and implementation.
• Support the design and installation of new equipment, including:
• Developing scopes of work
• Providing technical options and recommendations
• Offering fermentation/purification expertise during design and installation
• Support Asset Delivery (C&Q) activities, including:
• User Requirements
• Design Reviews
• Verification Strategy
• Kneat test case execution
• Provide technical oversight during field implementation.
• Support BCP-related tasks such as spare parts assessments and procurement.
• Support implementation of CAPAs, including procedure updates, engineering documentation revisions, equipment replacements, and change control generation.
• Execute and document engineering assessments.
• Participate in investigations and problem-solving activities, including:
• Root Cause Analysis
• FMEA
• Problem Analysis
• Provide technical input and documentation support for troubleshooting and investigations.
• Provide status updates to process teams and engineering leadership.
• Track ongoing activities, escalate issues, and follow up on required approvals.

Requirements

Qualifications

• Bachelor’s, Master’s, or Doctorate in Engineering
• Doctorate, OR
• Master’s + 2 years of engineering experience, OR
• Bachelor’s + 4 years of engineering experience
• Experience in Process Engineering, C&Q/Asset Delivery, and Kneat
• Experience supporting capital projects, equipment installation, and verification
• Familiarity with GMP/GLP and regulated documentation systems
• Experience with investigations, CAPAs, and structured problem-solving
• Strong technical writing and communication skills (English & Spanish)

Preferred Qualifications

• Mechanical, Electrical, Industrial, Chemical, or related engineering background
• Experience with fermentation/purification systems
• Experience with automated and manual inspection equipment
• Knowledge of inspection technologies for parenteral or glass containers
• Strong organization, presentation, and change management skills
• Ability to collaborate with cross-functional teams (Manufacturing, QA, Utilities, Facilities, Automation, IS)
• Experience supporting complex system or facility modifications
• Ability to manage multiple priorities and provide timely updates

Benefits

• one-year assignment with possible extension