Process Engineer II
Rockville, MD 20847
Summary of Position:
As a Process Engineer, you will provide engineering support for technology transfer, process validation, and GMP manufacturing for the company products. Will engage in automation and technology application activities within the organization and with outside partners (i.e. vendors). You will work with the Manufacturing team to design and scale-out manufacturing processes, and support manufacturing operations, as well as improve existing manufacturing operations. This role will serve as a lead in the selection and implementation of new processing equipment and modifications to existing equipment in the GMP Manufacturing Facility and related systems. This individual will work closely with a cross functional team in order to meet the needs of the manufacturing facility.
Responsibilities and Job Duties:
- Lead the design, implementation, and commissioning for new processing equipment and modifications to existing equipment within GMP Manufacturing while maintaining company quality and safety standards.
- Draft and review protocols, production procedures, and provide technical assessment and approval for engineering and process changes as well as documentation pertaining to process development, qualification, and validation to meet regulatory requirements.
- Work with industry /consultants to create design specifications, P&ID drawings, GA drawings, User Requirements, Functional Specifications and automation control strategies. Drive standardization within the department and within the company.
- Write and review technical documentation such as protocols and reports for FATs, SATs, and IQ/OQ/PQ testing.
- Ensure successful manufacturing production runs by assessing risk, setting preventative measures in place, investigating and troubleshooting equipment and process issues. Bring unresolved issues to supervisor and/or other team members.
- Participate in cross-functional teams to improve existing processes and drive change to increase efficiencies or minimize waste. Implement change management tactics to increase overall effectiveness of new processes and procedures
- Provide technical solutions to equipment and/or process problems, develop reports that evaluate multiple solutions, share findings with appropriate personnel and make recommendations for problem resolution.
- Perform investigations of manufacturing deviations and anomalies related to failure of facility systems.
- Perform process monitoring, process capability, statistical analysis and quality engineering activities.
- Prepare new and revise current drawings on vendor-provided documents and in-house redlines. Review drawings and designs for adherence to established specifications and standards.
- Provide support with implementing new processes to the manufacturing area, assist with equipment process fit, lead any required equipment modifications, lead procurement activities for any needed new equipment. Support technology transfer
- Provide afterhours technical and troubleshooting support as needed
- Other duties as assigned
Education & Credentials
- Bachelor’s degree in Chemical, Biochemical or Mechanical Engineering, Biotechnology or a related degree or equivalent years of education and experience
- Minimum of 2 years of related experience
- Previous experience in manufacturing, development or supporting manufacturing operations, preferably in the biotech or pharmaceutical industry
Knowledge, Skills and Abilities
- Working knowledge of cGMP manufacturing and regulatory requirements for biologics and pharmaceuticals
- Ability to write technical reports and to develop data gathering schedules
- Capable of performing risk assessments
- Willingness to work with a “hands-on" approach in project construction, testing, and support
- Must have effective oral and written communication skills
- Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision.
- Computer skills: MS Office Suite, MS Project, and AutoCAD.
- Capable of effectively negotiating contracts, bids, and change orders with vendors or contractors for equipment or systems
- Demonstrates a proficient understanding of equipment, instrumentation, and materials of construction to design, specify, procure, start-up, fully commission and troubleshoot equipment and systems
- Strong Knowledge of industry standards and guidelines, such as, ASME BPE, ISPE Baseline Guides and CFR’s
- Equipment qualification experience in a cGMP environment (IQ, OQ, PQ)
- Experience performing process design and process automation
- Certified Quality Engineer, Six Sigma Green Belt, Six Sigma Black Belt or similar
- Process validation experience
- Experience performing discrete event simulation