Associate Process Engineer - Biopharma (JP13416)

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.