Work Location: Gaithersburg, MD
Job Title: Engineering Technical Services (ETS) Engineer
Duration: 6 Months (Temporary/Contract) - Possible extensions, or full-time conversion
-The ideal candidate would have a BS in Chemical Engineering and a few years of experience working as an engineer supporting GMP biotech manufacturing.
-The HM would possibly be open to candidates who have a BS in Chemical Engineering and working experience as a manufacturing tech supporting GMP biotech manufacturing.
-The HM would also be open to a recent Chem Engineering graduate looking for their first engineering job. If they don't have any professional experience, then some relevant summer internships or co-ops would be helpful.
Schedule --- First Shift: 7:30 am to 4:30 pm, but the exact hours are negotiable
Length: 6 months contract with possible extensions, or full-time conversion.
Scope of Role:
Engineer to work in Engineering Technical Services (ETS) as a process equipment SME, supporting clinical manufacturing in Manufacturing Sciences (MS) in Gaithersburg.
This position reports to a Senior Engineer in Engineering Technical Services supporting GMP clinical biomanufacturing. Responsible for maintaining reliable process equipment performance in one or more manufacturing areas at the Gaithersburg Clinical Manufacturing facilities including cell culture, purification, and support systems.
• Subject Matter Expert (SME) for biopharmaceutical manufacturing equipment in assigned area(s)
• Resolves daily operational issues in assigned area(s)
• Manages projects and coordinates shutdowns.
• Supports new engineering projects. Creates project scopes, URS, and timelines
• Performs troubleshooting, corrections, and process performance optimization
• Monitors bioprocess equipment performance. Identifies equipment issues and helps develop technical solutions
• Determines process requirements. Helps design, install, and commission new processes and equipment
• Writes cGMP documentation (SOPs, change controls, validation protocols, etc.)
• Performs quality/safety investigations, and risk evaluations. Owns and executes Quality and Safety CAPAs.
• Performs GMP change control activities.
• Writes, tracks, and executes SAP work orders, and creates and revises Preventative Maintenance plans
• Reviews specifications, work instructions, protocols, drawings, and reports for technical accuracy
• Provides on-call support and works overtime as needed.
Prior GMP experience in a biotech or sterile pharmaceutical manufacturing environment a plus. Prior experience with production scale biotech process equipment a plus. Prior experience with Trackwise a plus.
Candidates without a BS in engineering require a minimum of 2-years of experience in GMP biotech manufacturing
• Good at trouble shooting and problem solving.
• Good oral and written communication skill, and good admin skills
• Good interpersonal skills
PROBLEM SOLVING COMPLEXITY:
Works on routine technical problems of limited scope and complexity.
§ Completes many routine tasks and helps contribute to the completion of some non-routine tasks
§ Contributes to completion of milestones for specific projects.
• Failure to achieve results or erroneous decisions may cause delays or product loss.
As a Kelly Services employee, you will have access to numerous perks, including:
Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly® Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we’re here every step of the way to find your dream engineering job.
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.]]