Associate Process Engineer - Biopharma (JP13416)
Company: 3 Key Consulting
Location: Holly Springs
Posted on: April 1, 2026
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Job Description:
Job Title: Associate Process Engineer - Biopharma (JP13416)
Location: Holly Springs, NC. 27540 Business Unit: Engineering &
Automation Employment Type: Contract Duration: 12 months with
possible extensions or conversion to FTE Rate : $30-33/hr W2 with
benefits Posting Date: 11/26/2024 Note : 100% onsite - regular
working hours - potential on call rotation occasionally. 3Key is
hiring! We are looking for Associate Engineer for a consulting
engagement with our direct client, a leading global biotechnology
company. Ideal Candidate: B.S. in chemical or mechanical
engineering. Some pharma experience in drug substance manufacturing
is a plus. Looking for a go getter with some general working
experience. (Does not have to be related to this position.) Key
Responsibilities: Develop, coordinate, analyze, and present results
for operational issues and engineering projects Provide technical
support to commercial and clinical manufacturing as needed,
specific to process control and process equipment. Working closely
with multiple subject areas, including manufacturing, process
engineering, process development, utility operations, maintenance,
quality assurance, and validation to implement operational
improvements Communicating with supervisor and support staff,
highlighting issues and proposing solutions. Work in a small group
of engineers and/or technicians on an ongoing or project basis.
Complete tasks under the general direction of lead engineers to
complete design and engineering within schedule and budget
constraints. Provide technical support and issue resolution with
24x7 on-call support of process systems on a rotational based
frequency. Provide system ownership for assigned equipment, and
supporting operations at the site. Provide engineering support for
design, construction, startup, commissioning and qualification.
Lead or work with teams in design, development and selection of new
systems, instruments, calibration capabilities and consumable
components. Evaluate capabilities of current and potential
suppliers, and assess new technologies that could provide cost
savings, throughput, or other unique capabilities to Amgen
manufacturing. Identify, support, and/or lead implementation of
engineering-based improvements or upgrades in small to medium scope
and complexity. Lead the development of calibration/maintenance
programs, ensure the availability of spare parts, and coordinate
maintenance execution as necessary to ensure systems are in proper
working order. Ensure systems are installed and operating safely
and comply with pertinent environmental health/safety practice,
rules and regulations. Ensure necessary commissioning and
qualification of systems is completed in alignment with site GMP
requirements and interact with regulatory inspectors as necessary.
Apply basic engineering principles and practices in support of
daily operation, maintenance, and troubleshooting of plant and
process systems. Monitor systems to identify performance risks and
implement risk reduction strategies. Providing troubleshooting
support to reduce production downtime. This will involve leading
and/or supporting technical root cause analysis and implementation
of corrective/preventive action. (Support may be required outside
of normal working hours including nights, weekends and holidays)
Support new product/technology introductions by performing
engineering assessments, implementing equipment modifications, and
supporting engineering runs. Advance the use of condition based and
predictive maintenance practices by incorporating advanced data
analytics where applicable. Own investigations of abnormal
conditions through Deviation and business processes. Basic
Qualifications: Bachelor’s degree Or Associate’s degree and 4 years
of Process Engineer experience Or High school diploma / GED and 6
years of Process Engineer experience. Ability to provide On-Call
support coverage nights and weekends, on a rotating basis.
Preferred Qualifications: Bachelor’s degree in engineering or
related technical field Position requires strong written and verbal
skills and the ability to work with minimum direction. Demonstrated
interpersonal and facilitation skills and ability to work in a
collaborative team-based environment. Ability to apply analytical
skills to evaluate and interpret sophisticated problems using
multiple sources of information. Ability to function within
cross-functional teams and embrace a team-based environment.
Experience with Mammalian Cell Culture, Protein Purification, Clean
Utilities, CIP, SIP, Production Services, and/or non-GMP Utilities
preferred Familiarity with designing and operating equipment used
in biopharmaceutical manufacturing preferred Top Must Have Skill
Sets: Strong working ethic Strong communication B.S. in chemical or
mechanical engineering Pharma experience Employee Value
Proposition: Unique industry experience Career growth Networking
Interview Process: Manager screening followed by panel interviews
(potential for these to be in person). We invite qualified
candidates to send your resume to recruiting@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. Regards, 3KC Talent
Acquisition Team
Keywords: 3 Key Consulting, Chapel Hill , Associate Process Engineer - Biopharma (JP13416), Engineering , Holly Springs, North Carolina
