Process Engineer

Job Description

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

Full-time