Process Engineer

CBSbutler

North Carolina

On-site

USD 86,000 - 132,550

Full time

14 days+

Get more replies from employers

Send a job-specific resume in minutes.

Job summary

A leading recruitment firm is seeking a Process Engineer II to join the Manufacturing Sciences and Technology (MSAT) team in North Carolina. The role involves assessing and supporting new manufacturing processes for advanced therapies. The ideal candidate has over 3 years of experience in engineering within the pharmaceutical industry, with skills in chromatography and a strong understanding of cGMP requirements. This position offers a full-time contract with competitive compensation.

Qualifications

3+ years' experience in a technical engineering role or related area.
3+ years' experience in pharmaceutical or biologics industry.
Experience with monoclonal antibody production is an advantage.

Responsibilities

Act as the technical expert for viral vector manufacturing.
Lead the introduction of new manufacturing processes.
Support onboarding of new process equipment.

Skills

Technical engineering experience

Leadership skills

Relationship-building

Organizational skills

Knowledge of cGMP requirements

Tools

Chromatography

Clarification systems

TFF systems

Job description

My client is looking for a Process Engineer II to join our Manufacturing Sciences and Technology (MSAT) team. In this role, you’ll play a key part in assessing, transferring, and supporting new manufacturing processes that enable both clinical and commercial production of advanced therapies.

Key Responsibilities

Act as the Downstream technical expert (clarification, chromatography, TFF, sterile fill/finish) for viral vector manufacturing within the MSAT team.
Serve as Technology Transfer Technical Lead for cross-functional teams.
Lead the introduction of new manufacturing processes and methods to support clinical and commercial manufacturing of multiple cell and gene therapy drug substances and products.
Drive information transfer and gap assessments for new process and method transfers.
Support drafting and review of MSAT and Manufacturing documentation, with strong understanding of equipment, critical process parameters, and in-process testing.
Lead facility fit assessments of manufacturing processes within production suites, using FMEA or similar risk-based tools to troubleshoot process issues.
Author and execute tech transfer plans, engineering studies, risk assessments, technical reports, change controls, and process validation plans/protocols.
Provide guidance on documentation of events and deviations during cGMP manufacturing.
Support onboarding of new process equipment.
Contribute to additional activities as required by management.

Requirements

3+ years’ experience in a technical engineering role or related area (or an equivalent combination of education and experience).
3+ years’ experience in the pharmaceutical or biologics industry in process development or manufacturing operations.
Experience delivering special projects focused on operational process improvement.
Strong leadership, relationship-building, and organisational skills.
Willingness and ability to learn and adapt across different areas within MSAT.
Knowledge of cGMP requirements for bioprocess drug substance manufacturing.
Experience in bioprocess drug substance process development and cGMP manufacturing.
Experience with monoclonal antibody production and purification is an advantage.
Technical understanding of upstream and downstream operations, including equipment and processes such as disposable technologies, clarification, chromatography skids, TFF systems, formulation, and final fill.

Looking forward to speaking with you!

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Engineering and Manufacturing

Industries

Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Chemical Manufacturing

Wilmington, NC $86,000.00-$132,550.00 7 months ago

Hickory, NC $83,750.00-$115,156.00 3 weeks ago

Wilson, NC $88,000.00-$132,000.00 2 weeks ago