Process Engineer

Job Title:

Process Engineer

Job Description

This Process Engineer role focuses on translating complex drug substance process requirements into practical equipment functionality and automation solutions within large-scale pharmaceutical manufacturing operations. The position provides technical leadership across process, automation, and commissioning activities, with a strong emphasis on downstream purification and integration into automated control systems such as Delta

V. The engineer will operate as an independent contributor, serving as a subject matter expert for downstream purification process engineering in a post-design, execution-phase environment.

Responsibilities

+ Translate detailed process requirements into equipment functionality and automation specifications for drug substance manufacturing operations.

+ Interpret process needs and verify alignment with already designed and issued-for-construction (IFC) equipment systems.

+ Provide engineering guidance and leadership to automation and commissioning teams throughout project execution.

+ Partner closely with Delta

V and automation engineers to ensure process intent is accurately implemented within control systems.

+ Support the integration of purification processes into automated manufacturing environments, with a focus on downstream operations.

+ Serve as a technical subject matter expert for downstream purification process engineering, offering hands-on support and troubleshooting.

+ Collaborate cross-functionally with process, automation, and commissioning teams to ensure seamless project execution.

+ Participate in post-design and execution-phase activities, ensuring that built or IFC'd equipment and automation systems meet process and operational requirements.

+ Communicate effectively with engineering, automation, and operations stakeholders to align expectations and resolve technical issues.

+ Contribute to continuous improvement of process, equipment, and automation interfaces in a large-scale pharmaceutical manufacturing setting.

Essential Skills

+ Strong drug substance process engineering experience, with a focus on large-scale manufacturing operations.

+ Hands-on experience with purification processes, particularly downstream purification.

+ Proven ability to translate process requirements into equipment and automation solutions.

+ Experience working in post-design and execution-phase environments where equipment is already built or issued for construction (IFC).

+ Experience working with or alongside Delta

V design and automation resources.

+ Experience supporting automation integration and commissioning activities.

+ Experience working in GMP pharmaceutical or biotechnology environments.

+ Ability to work as an independent contributor with minimal oversight.

+ Strong communication skills with the ability to interface effectively across engineering, automation, and operations teams.

+ Bachelor's degree in Chemical Engineering, Biochemical Engineering, or a related engineering field.

Additional

Skills & Qualifications

+ Delta

V experience strongly preferred, including collaboration with control system design and implementation teams.

+ Familiarity with large-scale biologics or drug substance manufacturing operations.

+ Demonstrated ability to operate in a post-design execution environment and adapt to existing equipment and automation configurations.

+ Experience working on long-term, large-scale pharmaceutical manufacturing projects.

+ Strong cross-functional collaboration skills, particularly with process, automation, and commissioning stakeholders.

Work Environment

The role is based in a post-design, execution-phase environment, supporting a large-scale pharmaceutical manufacturing project. The Process Engineer will work as an individual contributor, collaborating closely with process, automation, and commissioning teams in a highly technical, GMP-regulated setting. The environment involves integration of purification processes into automated manufacturing systems, including Delta

V-based control platforms, with a focus on ensuring that existing equipment and IFC'd systems meet process and operational requirements.

Job Type & Location

This is a Contract position based out of Apex, NC.

Pay and Benefits

The pay range for this position is $40.00 - $55.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:  - Medical, dental & vision  - Critical Illness, Accident, and Hospital  - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available  - Life Insurance (Voluntary Life & AD&D for the employee and dependents)  - Short and long-term disability  - Health Spending Account (HSA)  - Transportation benefits  - Employee Assistance Program  - Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully…