Downstream Process EngineerTechnical Source • Holly Springs, NC, US

Downstream Process Engineer

Technical Source • Holly Springs, NC, US

30+ days ago

Job type

Full-time

Job description

Job Description

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.

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.

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Engineer • Holly Springs, NC, US

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