3key Consulting, Inc.
Process Engineer, Biotech Process Equipment Owner - (JP14141)
3key Consulting, Inc., Holly Springs, North Carolina, United States, 27540
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 client, a leading global biopharmaceutical company. Ideal candidate
is a commercially experienced Process Engineer with a BS in Chemical, Mechanical, or Biomedical Engineering, supporting large-scale drug substance operations in biotech or pharma. They are hands-on with equipment ownership (not maintenance), adaptable, collaborative, and proactive. They embrace ambiguity, solve complex operational problems, and thrive in a startup-like GMP environment, supporting dynamic needs and continuous improvement initiatives. Recruiters will thoroughly pre-screen for tangible examples of initiative and project ownership, with resumes demonstrating practical accomplishments and team-based efforts. Not a maintenance role:
They design/own the equipment and support proper maintenance planning, not execution. The role is based at a new biologics manufacturing plant featuring a FleX Batch facility with disposable technologies and traditional systems, supporting industry 4.0 capabilities and sustainability initiatives. Top Must Have Skills: Experience in commercial biotech manufacturing Strong problem-solving skills in complex and ambiguous situations Ability to work well collaboratively Responsibilities: Serve as system owner for process equipment supporting manufacturing Support design, startup, commissioning, and qualification of systems Lead small-to-medium equipment or facility improvements Develop maintenance programs, ensure spare parts availability, and coordinate execution Ensure safety and compliance with EHS standards Support GMP-related commissioning and qualification activities Apply engineering principles in daily operations and troubleshooting Monitor system performance and implement risk-reduction strategies Lead troubleshooting and root cause analysis Support new product and technology introductions Advance predictive maintenance and data analytics Participate in deviation investigations and quality processes Analyze operational issues and engineering projects Provide technical support for manufacturing processes and equipment Collaborate across functions to improve operations Maintain communication with leadership and team members Participate in project work and provide on-call support for utility systems Assist in system design, selection, and technology assessment Preferred Qualifications: Bachelor’s in Chemical or Mechanical Engineering 3+ years relevant experience, including 2+ in biopharma manufacturing Hands-on experience with GMP equipment like bioreactors, centrifuges, filtration, and purification systems Proficiency with control systems and troubleshooting Experience in regulated environments and quality systems Strong communication and technical writing skills Team collaboration and facilitation skills Analytical thinking and problem interpretation Support for capital projects and process improvements Understanding of GMP capital project execution Commitment to safety and compliance Organizational and multitasking skills, willingness to work flexible hours Why is the Position Open?
Additional team member Red Flags: Employment gaps without justification Design/own equipment support, not maintenance Not suitable for candidates seeking research roles or with no biotech experience Lack of relevant degree or experience Rigid personalities or discomfort with ambiguity Interview process:
Manager phone screening, panel interviews, follow-up with hiring manager. Send resumes to
resumes@3keyconsulting.com . Visit www.3keyconsulting.com/careers for other opportunities. Feel free to share this with interested candidates.
#J-18808-Ljbffr
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 client, a leading global biopharmaceutical company. Ideal candidate
is a commercially experienced Process Engineer with a BS in Chemical, Mechanical, or Biomedical Engineering, supporting large-scale drug substance operations in biotech or pharma. They are hands-on with equipment ownership (not maintenance), adaptable, collaborative, and proactive. They embrace ambiguity, solve complex operational problems, and thrive in a startup-like GMP environment, supporting dynamic needs and continuous improvement initiatives. Recruiters will thoroughly pre-screen for tangible examples of initiative and project ownership, with resumes demonstrating practical accomplishments and team-based efforts. Not a maintenance role:
They design/own the equipment and support proper maintenance planning, not execution. The role is based at a new biologics manufacturing plant featuring a FleX Batch facility with disposable technologies and traditional systems, supporting industry 4.0 capabilities and sustainability initiatives. Top Must Have Skills: Experience in commercial biotech manufacturing Strong problem-solving skills in complex and ambiguous situations Ability to work well collaboratively Responsibilities: Serve as system owner for process equipment supporting manufacturing Support design, startup, commissioning, and qualification of systems Lead small-to-medium equipment or facility improvements Develop maintenance programs, ensure spare parts availability, and coordinate execution Ensure safety and compliance with EHS standards Support GMP-related commissioning and qualification activities Apply engineering principles in daily operations and troubleshooting Monitor system performance and implement risk-reduction strategies Lead troubleshooting and root cause analysis Support new product and technology introductions Advance predictive maintenance and data analytics Participate in deviation investigations and quality processes Analyze operational issues and engineering projects Provide technical support for manufacturing processes and equipment Collaborate across functions to improve operations Maintain communication with leadership and team members Participate in project work and provide on-call support for utility systems Assist in system design, selection, and technology assessment Preferred Qualifications: Bachelor’s in Chemical or Mechanical Engineering 3+ years relevant experience, including 2+ in biopharma manufacturing Hands-on experience with GMP equipment like bioreactors, centrifuges, filtration, and purification systems Proficiency with control systems and troubleshooting Experience in regulated environments and quality systems Strong communication and technical writing skills Team collaboration and facilitation skills Analytical thinking and problem interpretation Support for capital projects and process improvements Understanding of GMP capital project execution Commitment to safety and compliance Organizational and multitasking skills, willingness to work flexible hours Why is the Position Open?
Additional team member Red Flags: Employment gaps without justification Design/own equipment support, not maintenance Not suitable for candidates seeking research roles or with no biotech experience Lack of relevant degree or experience Rigid personalities or discomfort with ambiguity Interview process:
Manager phone screening, panel interviews, follow-up with hiring manager. Send resumes to
resumes@3keyconsulting.com . Visit www.3keyconsulting.com/careers for other opportunities. Feel free to share this with interested candidates.
#J-18808-Ljbffr