Graduate Process Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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JOB SUMMARY

The Process Engineer Global Technical Operations /Life Cycle Management (GTO/ LCM) is individual contributor who is responsible for providing engineering and technical support for production and processing equipment. He/she will manage and assist in the technical qualification of processes aid in the resolution of engineering technical issues that may require the development of new or improved techniques or procedures and lead related activities for designated commodities. The position provides technical leadership for manufacturing processes and equipment. He/she will support a Senior or Staff engineer under the direction of an Engineering manager for the technical qualifications for medical device process development and validation for clinical articles and commercial manufacturing lines including scoping designing executing data analysis deviations investigation and providing technical support to supply chain stakeholders.

The role is responsible for the Life Cycle Management (LCM) of Nijmegen ETHIZIA manufacturing process and will serve under the guidance of an Engineering Manager and/or Subject Matter Expert (SME)

Key Responsibilities

Under limited supervision and in accordance with all applicable federal state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines this position:

• Provide end-to-end technical support for medical device process development scale-up and validation (clinical and commercial) including process characterization risk management and ongoing performance optimization

• Lead and support continuous improvement initiatives capacity expansion validation remediation and technology roadmap development for manufacturing processes

• Collaborate cross-functionally with R&D Quality and external suppliers to support product development technology transfer and lifecycle management; act as liaison for process development and supplier qualification

• Design experiments apply statistical analysis and generate technical reports to support decision-making and process improvements

• Execute and support equipment and process validation activities (URS FAT/SAT IQ/OQ/PQ) including authoring and reviewing protocols and reports in compliance with GMP and ISO standards

• Investigate process deviations resolve technical issues and drive projects to improve quality yield and supply chain performance

• Manage and communicate technical (and some business) risks issues and opportunities to stakeholders and leadership

• Ensure compliance with health safety environmental and regulatory requirements; perform additional duties as needed

Essential Qualifications

• Bachelors degree (or equivalent) in Engineering or a related scientific field (Mechanical Manufacturing Biomedical or Chemical preferred)

• Minimum 12 years of relevant professional or internship experience

• Good project management skills

• Good communication skills

Desirable Qualifications

• Strong project management communication and cross-functional collaboration skills

• Experience or exposure to process engineering activities including process development scale-ups cost improvement projects (CIPs) troubleshooting CAPA change control and process qualification

• Familiarity with equipment specification and validation (URS FAT/SAT IQ/OQ/PQ)

• Working knowledge of statistical analysis (e.g. Minitab) Design of Experiments (DoE) and Six Sigma methodologies

• Proficiency in MS Office applications (including MS Project)

• Knowledge of manufacturing processes in regulated industries (medical devices pharmaceuticals biologics) including device assembly chemical or drug product processes

• Ability to investigate and resolve technical and operational issues including customer complaints using root cause analysis and risk management tools

• Experience authoring and reviewing technical documentation for validation and compliance

• Ability to manage projects aligned with quality improvement cost reduction cycle time optimization and capacity increases

• Experience supporting product launches and technology/process transfers in collaboration with cross-functional teams

• Familiarity with cleanroom environments supplier coordination (RFQs ordering) and equipment qualification (advantage)

• Strong understanding of regulatory quality health safety and environmental compliance requirements

• Working knowledge of technical documentation control and retention processes

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The anticipated base pay range for this position is:

Benefits:

In addition to base pay we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location where the actual amount is based on the employees and companies performance of the previous calendar year or sales commissions. Moreover we offer vacation days parental leave for a minimum of 12 weeks bereavement leave caregiver leave volunteer leave well-being reimbursement programs for financial physical and mental health. We also offer service anniversary and recognition awards and subject to the terms of their respective plans employees - and in some locations eligible dependents - can participate in several insurance plans. For more information visit Employee benefits Supporting well-being & career growth Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

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