Apply to 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.