What are the responsibilities and job description for the Process Engineer, Biotech Process Equipment Owner - (JP14141) position at 3 Key Consulting?
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:
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:
Why is the Position Open?
Additional team member
Red Flags:
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.
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.
- 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.
Salary : $32 - $38