Engineer/Scientist Rotational Program
MAJOR DUTIES AND RESPONSIBILITIES
- Support the operation of GMP / Non GMP manufacturing systems (Systems include Process Automation Systems, Manufacturing Execution Systems, Process Development, Technology Transfer, Laboratory, Manufacturing Operations) in the associated facilities.
- Provide Troubleshooting support and guidance of systems in support of manufacturing, process development, and/or Lab operations within a collaborative team.
- Collaborate in investigations of proprietary automation software/hardware, manufacturing operations, process development, along with vendors when necessary.
- Participate in Incident/Issue Investigations, CAPA & Safety related corrective actions and manufacturing support.
- Communicate proactively with supervisor and colleagues, highlighting issues and proposing solutions.
- Follow applicable standard operating procedures while working in validated systems and processes.
- Design and execution of protocols to solve process-related manufacturing investigations and enable the technology transfer of new processes.
- Use of laboratory and at scale equipment used in cell culture, and downstream process steps.
- Documentation of data and results, data verification, interpretation of small scale and at scale data supporting the manufacturing processes and preparation of final reports to summarize the findings.
- Support 24/7 manufacturing operations that may include shift coverage consisting of on call, day shifts, and/or weekend coverage.
KNOWLEDGE AND SKILL
- Bachelor's degree in Chemical Engineering, Life Sciences / STEM degree or equivalent combination of education and technical experience.
- 0 - 2 years working experience with control systems or manufacturing systems along with theoretical and applied knowledge of Bio/Chemical processing operations, and computerized systems.
- Must demonstrate an ability to understand and apply software solutions.
- Must demonstrate an ability to execute complex projects and troubleshoot complex problems.
- Must be able to successfully work independently as an individual contributor and collaborate within teams.
- Must be able to work in a fast-paced multi-tasking environment and execute multiple complex technical projects.
- Must have strong interpersonal skills as well as excellent verbal and written communication skills.
- Understanding of expectations working in a regulated industries such as Biotech, Pharmaceutical, Medical Device or Food-Beverage is a plus.
- Critical skills include a high degree of initiative, strong scientific skills, and attention to detail.
- Desire to be in a rotational program across multiple functions over the course of 2 years.
- WORKING CONDITIONS
- Works in both a GMP manufacturing environment and an office setting. Works within all Site Facilities requiring a high attention to detail. Works within the labs and manufacturing facility where hazardous chemicals may be present and PPE will be required at times.
- Work with all departments and with all levels of the organization, specifically Quality, Validation, Manufacturing Laboratories, Process Engineering, Analytical Functions and Manufacturing Operations.
- This position provides support of 24/7 manufacturing operations. Shifts may require weekend coverage on an alternating schedule, or on call availability.
- Works on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Position is supervised by Lead Engineer or department Supervisor. Daily direction and alignment is maintained. Work is performed under general direction. Works with team / supervision to determine and develop approaches to solutions. Work is reviewed upon completion for adequacy in meeting objectives. May receive assignments which have a partially defined process to complete the assignment.
- Candidates will receive mentorship throughout course of rotation program.
- Project-based supervision of internal or external resources may be required.