Apply to Process Engineer, Biotech Process Equipment Owner - (JP14141)

Job Title: Process Engineer, Biotech Process Equipment Owner - (JP14141)
Location: Holly Spring, NC. 43054
Employment Type: Contract
Business Unit: ANC Engineering & Automation
Duration: 3 years with likely extensions and/or conversion to permanent
Number of openings: 3
Posting Date: 06/04/2025
Pay Rate: $32 - $38/hour
Notes: Standard business hours (~8 to 5) with flexibility for: Evening or weekend work, Occasional holiday support, Up to ~50 hours/week, assuming occasional OT

3 Key Consulting is hiring Process Engineers for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Ideal candidate is a commercially experienced Process Engineer with a BS in Chemical, Mechanical, or Biomedical Engineering, who has supported large-scale drug substance operations in biotech or pharma. They are hands-on with equipment ownership (not maintenance) and are highly adaptable, collaborative, and proactive. The ideal candidate embraces ambiguity, is passionate about solving complex operational problems, and thrives in a startup-like GMP environment where they can wear multiple hats, support dynamic business needs, and help drive continuous improvement initiatives. Recruiters expected to pre-screen thoroughly and look for tangible examples of initiative and project ownership. Ideal resumes will show practical accomplishments and clearly demonstrate team-based, cross-functional efforts

Not a maintenance role:
They design/own the equipment and support proper maintenance planning, not execution.
This opportunity is based at a brand-new, advanced biologics manufacturing plant. The site features a cutting-edge FleX Batch facility that combines the latest in disposable technologies with traditional stainless-steel systems, enabling maximum operational flexibility. The facility integrates best-in-class manufacturing processes and industry 4.0 capabilities, along with sustainability initiatives designed to reduce carbon emissions and waste.

Top Must Have Skills:

Experience working in commercial biotech manufacturing industry.
Strong drive and proven results in solving complex and ambiguous problems.
Demonstrated ability to work well in highly collaborative environments.

Responsibilities:
In this role, the Engineer will report to the Senior Manager of the Process Engineering group and will provide daily engineering support to the site. Responsibilities include:

Serve as system owner for process equipment and systems supporting manufacturing operations.
Provide engineering support for design, construction, startup, commissioning, and qualification of new or modified systems.
Identify and/or lead implementation of small-to-medium scale equipment or facility improvements, including development of business cases.
Develop maintenance programs, ensure spare part availability, and coordinate execution to maintain system reliability.
Ensure systems operate safely and in compliance with EHS standards and regulations.
Support commissioning and qualification activities in alignment with GMP requirements and regulatory inspections.
Apply engineering principles in daily operations, maintenance, and troubleshooting of plant systems.
Monitor system performance and implement risk-reduction strategies.
Lead or support troubleshooting efforts to minimize production downtime, including root cause analysis and CAPA implementation.
Support new product and technology introductions via engineering assessments, equipment modifications, and pilot runs.
Advance use of predictive maintenance and condition-based monitoring using data analytics where applicable.
Lead or contribute to deviation investigations and other quality-related processes.
Analyze and present findings related to operational issues and engineering projects.
Provide technical support to commercial and clinical manufacturing, specifically in process control and equipment.
Collaborate with cross-functional groups such as manufacturing, process development, utilities, maintenance, quality, and validation to drive operational improvements.
Maintain regular communication with leadership and team members, escalating issues with proposed solutions.
Participate in a small engineering team on a project or ongoing support basis.
Provide rotational on-call support for utility systems, including nights, weekends, and holidays as needed.
Participate in the design and selection of systems, instrumentation, and components.
Evaluate supplier capabilities and assess new technologies to improve cost, throughput, or technical capabilities.

Preferred Qualifications:

Bachelor’s degree in Chemical or Mechanical Engineering.
3+ years of relevant work experience, including 2+ years in a biopharmaceutical manufacturing environment.
Hands-on experience with GMP production equipment such as bioreactors, centrifuges, filtration systems, and purification technologies.
Proficiency with equipment and facility control systems, including troubleshooting and logic understanding.
Experience in regulated environments (e.g., cGMP, OSHA, EPA) and knowledge of quality systems (e.g., change control, non-conformances, CAPA, validation).
Strong communication, technical writing, and presentation skills; ability to work independently.
Proven team collaboration and facilitation skills.
Analytical thinking with the ability to interpret complex problems using multiple data sources.
Ability to support capital projects and implement process improvements.
Understanding of capital project execution from procurement through validation in GMP environments.
Commitment to safety and compliance in all engineering activities.
Self-starter with excellent organization, time management, and multitasking skills.
Willingness to work flexible hours in support of 24/7 manufacturing operations.

Why is the Position Open?
Additional team member

Red Flags:

Gaps in employment without clear justification
Not a maintenance role: They design/own the equipment and support proper maintenance planning, not execution.
Not a research role. Candidates with advanced degrees seeking research roles should not be submitted.
Lack of biotech experience.
Lack of desired degree (Chemical, Mechanical, or Biomedical Engineering).
Rigid personalities or candidates uncomfortable with ambiguity or startup-like agility

Interview process:
Manager Phone Screening followed by interview panels and post panels follow-up meeting with hiring manager.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.