Job Description

Overview

Technical Source is seeking an experienced Process Engineer to provide technical leadership in support of capital projects, technology transfer, and day-to-day manufacturing operations. This role is key to ensuring compliance with safety, regulatory, and engineering standards while driving plant efficiency, reliability, and continuous improvement.

Preferred Background

• 5+ years of pharmaceutical industry experience in an engineering role.
• Hands-on expertise in root cause analysis and troubleshooting of downstream equipment, with a strong focus on chromatography skids and UF/DF skids.

Key Responsibilities

• Serve as a primary engineering contact for capital projects and external EPCM providers.
• Ensure timely delivery of equipment packages, maintaining quality and compliance standards.
• Review and contribute to process design documents, including piping and instrumentation diagrams (P&IDs).
• Write and review User Requirement Specifications (URSs) for process equipment.
• Support Factory Acceptance Testing (FAT), Commissioning, Qualification and Validation (CQV), and start-up activities.
• Provide on-floor technical support for manufacturing equipment, addressing issues and ensuring smooth operations.
• Conduct impact assessments, risk assessments, and technology transfer (TT) activities for process equipment.
• Lead or support deviations, change controls, corrective and preventive action (CAPA) closures, and process deviation investigations.
• Collaborate across departments, including Quality, Manufacturing, Validation, Maintenance, and Safety.
• Deliver equipment training and serve as a subject matter expert within assigned areas.
• Support and implement continuous improvement initiatives to enhance operational efficiency.
• Cross-train across multiple unit operations to provide flexible team support.

Qualifications

• Bachelor’s degree in Engineering (Chemical, Mechanical, or related field).
• 5+ years of pharmaceutical engineering experience preferred, particularly in downstream process equipment.
• Strong knowledge of cGMP, regulatory standards, and technical risk assessments.
• Excellent problem-solving, analytical, and communication skills.
• Ability to work in a cross-functional, fast-paced environment with competing priorities.

Why Join Technical Source?

As a partner in your career journey, Technical Source connects top talent with leading opportunities in the life sciences industry. This position offers the chance to play a direct role in supporting critical pharmaceutical manufacturing operations while developing your expertise in process engineering.

Apply today to take the next step in your career with Technical Source.

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