Description
Title: Process Engineer
Location: Nijmegen
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
Summary of Role:
- Process Engineering role for process and sub processes of J&J NIJMEGEN site.
- Oversees Base Business & Project Activities for J&J NIJMEGEN Manufacturing Line.
- Manages and supports a team of engineers and technicians to meet all expectations around.
- Manufacturing processes by implementing all aspects of process improvement, facility layout and upgrades, equipment setup, testing, documentation, validation, problem solving.
- Responsible for and providing engineering and technical support for complex production and processing equipment.
- Provides process engineering and controls support. Plans and conducts activities related to new and existing manufacturing systems for industrial production processes including human work.
- Factors, material flow, cost analysis, and process optimization in both production and packaging operations.
- Contribute to either initiate or development of the asset life cycle consisting of 4Qs and process validation/verifications.
Key Responsibilities:
- Ensures workload and priorities of the role are aligned with business need.
- Is accountable for Base Business Activities & engineering projects, including remedial actions when applicable.
- Serves as the engineering reviewer/approver for process development studies and validation documentation in alignment with the Engineering Manager (including CSV).
- Represents engineering department for internal and external communication/reporting/meeting either as a standalone responsibility if applicable or as the Engineering Manager’s delegate.
- Maintains connection with other departments as appropriate.
- Provide input into annual budgets and manage project spending.
- Responsible for communicating business related issues or opportunities to next management level.
- For those who supervise/lead or manage a staff, responsible for ensuring that subordinates follow all company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
- Performs other duties assigned as needed.
Qualifications
Qualifications
- University / Bachelor’s Degree, Engineering degree or Equivalent in a Life Science,
- Process Engineering, or Physical Science. An advanced degree, such as Master degree in a Technical or Science field is preferred.
- Generally requires (4-6) years related experience.
- Statistical and analytical problem solving.
- Strong written and oral communication in English required.
- Experience in the Medical Device industry and GMP.
- Demonstrated knowledge of manufacturing principles and practices, and procedures.
Required Knowledge
- Equipment and Process Validation / Establish Equipment requirements (URS, FAT, SAT)
- Mechanical and automation background with 4 to 6 years in industry, preferred in medical field.
- Capable to interpret the process flow sheets.
- Capable to interpret the vendor maintenance/calibration/qualification reports to verify the effectiveness of the vendor’s work and adopt the outcomes into the process.
- Project management.
- Manufacturing processes improvements
- Lean and/or Six Sigma belt
- Troubleshooting and machine design review
- Proper communication skills; making complex issues easy for others to understand when acting as a core team member in projects.
#LI-CH2