Job Title: Associate Process Engineer, (JP13534)
Location: Holly Springs, NC. 27540
Business Unit: Engineering Automation
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $28 - $32/hour W2
Posting Date: 1/2/2025.
Notes: Only qualified candidates need apply. 100% ONSITE - regular working hours - potential on call rotation occasionally.


3 Key Consulting is hiring!  We are recruiting an Associate Process Engineer for a consulting engagement with our direct client, a leading global biotechnology company. 

Job Description:
Our ideal candidate will have a B.S. degree 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.)

Top Must Have Skill Sets:
•    Strong working ethics
•    Strong communication
•    B.S. in chemical or mechanical engineering
•    Pharma experience

Day to Day 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 support 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 client 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

Interview Process:
Manager screening followed by panel interviews (potential for these to be in person).

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.