MSAT Lead Process Engineer
Our client is seeking a Manufacturing, Science and Technology (MSAT) process engineer with hands-on experience working in a laboratory and pilot plant setting. This individual will be responsible for designing and executing laboratory / pilot plant experiments. This includes equipment process train design, set-up / break-down, experimental execution and result documentation. This also includes use of design of experiments, thorough data analysis and authoring technical reports. The engineer is expected to coordinate and prioritize experimental testing, work efficiently, and communicate findings to the team in a timely manner. Strong collaboration is expected within the MSAT group as well as with additional internal and external partners. The candidate should have strong communication & interpersonal skills, be able to multi-task and have a commitment to excellence.
- Have a strong commercial manufacturing plant presence
- Support the commercial processes which includes investigations and identifying process optimization opportunities / improvements with emphasis on yield improvement and reducing process variability
- Serve as group representative to CMC project teams
- Be the technical leader in late stage-small molecule scale-up
- Manage subordinate staff and direct / foster the professional development of scientific associates
- Develop strategies to meet customers technical and business needs
- Design and develop processes for producing clinical and commercial products
- Identify proprietary technical opportunities
- Technically support equipment and process validation efforts
- Design, plan and execute laboratory and pilot plant experiments. This includes the equipment and instrumentation design, procurement, installation, commissioning, operation, disassembling and cleaning
- Utilize theoretical and practical expertise to troubleshoot and resolve technical issues with experimental studies or commercial operations.
- Effectively document procedures and results in electronic notebooks and technical reports.
- Thorough analysis of data utilizing appropriate statistical methodologies and authoring technical reports and internal presentations to department leadership.
- Assist in maintenance and upkeep of the pilot plant facility and associated equipment. This includes trouble-shooting related equipment issues/problems.
- Coordinate the purchase of laboratory supplies, equipment and instrumentation as needed.
- Adhere to quality procedures in all work practices.
- Attend training sessions as appropriate.
- Issue regular updates on progress of projects.
- Coordinate sample submission and data oversight from internal and contract laboratories.
- Accountable to departmental leaders for ensuring proactive execution of work assignments to meet project demands.
- Proactively assist / support other team members with their work assignments.
Education & Experience Requirements:
- Minimum of BS degree in Chemical, Biomedical or Mechanical Engineering
- Minimum work experience in manufacturing, process development, or engineering (GMP environment preferable but not a necessity)
- 0+ years with PhD
- 3+ years with MS
- 5+ years with BS
Technical Knowledge/Skills Needed:
- Strong grasp on hypothesis testing, specifically using design of experiments
- Basic understanding of statistical process control
- Good technical writing skills
- High mechanical aptitude
- Good oral communicator with emphasis on communicating complex issues to non-technical personnel
- Computer skills: word processing, data processing, statistical analysis, graphing and presentation.
- Ability to work hard and contribute to an enjoyable working environment.
- Proactively achieves results for the betterment of the organization.
- Desire to learn new things and apply those learnings to implement novel improvements
- Grace under pressure.
- Ability to cope with a rapidly changing work environment and schedules.
- Commitment to teamwork.
- Commitment to continuous improvement in all areas.
- Ability to focus attention to details and ensure high quality work.
- Ability to work safely; seek out and encourage safe practices.
- Excellent problem-solving skills. Ability to generate technical options to resolve problems and select optimal solutions.