Process Engineer II - GMP

Baltimore, MD, US
Sep 22, 2019
Required Education
Bachelors Degree
Position Type
Full time
Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.

Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses.

The Process Engineer role requires an excellent understanding of mechanical and electrical systems in a bio pharmaceutical GMP manufacturing facility.

Key Responsibilities include but not limited to:

  • Hands-on experience in troubleshooting and repairing bioprocess equipment is critical. This equipment includes fermenters, centrifuges, chromatography skids, incubators, BSCs and various laboratory equipment.
  • Will work closely with facilities mechanics to minimize equipment down times, expedite PM schedules
  • Will assist in maintaining preventative maintenance programs for the bioprocess equipment; this includes generating preventative maintenance SOPs/records for various equipment (manufacturing/lab), change control, and facility quarantines.
  • Initiating/completing various types of GMP documentation such as change control, deviations, ICARs will be very important
  • Will be a company SME on bioprocess equipment across all operating departments (PD, Manufacturing, QC).
  • Will be relied upon for BAS operations for the facility.
  • Works with subcontractors as needed on equipment preventative maintenance and repairs.
  • Will assist as needed in other facilities groups such as metrology and the general maintenance/utilities group.
  • Accurately maintains/completes all equipment logbooks and maintenance records within a software maintenance management program.
  • Will aid in training of mechanics on the various pieces of bioprocess equipment throughout the facility.
  • Participation in facility expansion, validation will be expected.
  • Works under general supervision to meet project goals.
  • Will recommend parts/supply purchases for equipment within the manufacturing/lab areas.
  • Works closely with manufacturing/lab staff to troubleshoot and repair equipment problems.
  • Works closely with various departments at Paragon and helps as needed.
  • Must follow Paragon safety procedures, practices and the cGMPs.

Education & Experience:

  • Bachelor degree in Engineering or related scientific field preferred
  • 2-5 years work experience GMP / Bio-Pharma Maintenance &/or Engineering
  • Must have proficient knowledge of controls and automation operations
  • Must be able to demonstrate clear and effective communication skills
  • Class III Stationary Engineer's license is preferred
  • Will be working in an FDA regulated cleanroom environment that requires full gowning (tyvek coverall, gloves, hair cover, shoe covers.)
  • Must have the ability to lift/carry 40 lbs and to work on ladders/step stools.
  • Requires working extended periods on his/her feet in a fast-paced environment
  • Requires automation and controls engineering design, repairs and maintenance.
  • Shift work and/or weekend work will be required at times.

Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.