Senior Process Engineering

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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Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at Senior Engineer provides technical leadership within an assigned manufacturing value stream and/or engineering function (e.g. Process Packaging Materials/Supplier Equipment/Validation). The role leads complex engineering projects and initiatives supporting safety quality delivery cost and innovation objectives in a regulated (GMP/ISO/FDA) environment. The Senior Engineer is accountable for end-to-end execution of change control and validation/qualification activities (IQ/OQ/PQ as applicable) technical investigations continuous improvement and cross-functional delivery.

Responsibilities and accountabilities may vary by site. Applicable procedures and quality systems (e.g. QUMAS/eDMS where applicable) define responsibilities and may supersede elements of this position description.

The Senior Engineer is responsible for providing technical leadership within an assigned area and may have ownership for the following (as applicable to assignment):

1. Project Leadership & Delivery

• Leads and executes complex engineering and/or change control projects requiring conceptual evaluation design and validation.

• Applies project management methodologies to define scope schedule resources risks and deliverables; drives timely execution and closure.

• Performs concept analysis and supports development of capital/expense project justifications for future project development.

• Participates in and/or leads technical design reviews; translates requirements into robust manufacturing/product/equipment specifications.

2. Qualification Validation & Change Control

• Plans and executes complex qualification of new or modified equipment controls systems processes and/or packaging operations; supports vendor and site acceptance testing (FAT/SAT) as required.

• Leads validation strategy and execution (IQ/OQ/PQ) including protocol authoring execution oversight deviation management and report approval.

• Ensures high-quality technical documentation (protocols reports risk assessments work instructions specifications) in compliance with GDP and internal/regulatory standards.

3. Process / Packaging / Materials & Supplier Engineering (as applicable)

• Identifies and implements process equipment packaging and/or materials enhancements that improve efficiency yield reliability robustness and safety.

• Designs and executes characterization studies and experiments using statistical/analytical tools (e.g. DOE capability stability trending) to set new performance standards and drive breakthrough improvements.

• For packaging-focused assignments: leads packaging system design/development/validation and maintenance activities; qualifies packaging components/systems; establishes packaging specifications; leads packaging process/equipment validations; and supports labeling/packaging improvements aligned with applicable standards and regulatory requirements.

• For materials/supplier-focused assignments: serves as functional SME; leads material characterization worst-case/challenge testing and qualification activities for new/revised materials and suppliers; supports business continuity planning (BCP) initiatives related to materials/suppliers; and provides technical support to resolve material-related issues.

4. Troubleshooting Investigations Risk & CAPA

• Leads structured problem solving and root cause analysis for complex quality technical and manufacturing issues (e.g. deviations nonconformances audit actions CAPAs).

• Partners with Operations and Quality to implement corrective/preventive actions and sustain improvements; ensures effective risk assessments and controls.

• Provides training and technical guidance to engineers technicians and operations personnel to enable safe operation troubleshooting and maintenance of processes/equipment.

5. Coaching Mentoring & Influence

• Provides mentoring and technical guidance to junior engineers interns and/or co-ops; builds capability within the team.

• Demonstrates technical depth and influence within the functional team; serves as a change agent by promoting a learning culture and continuous improvement mindset.

6. Compliance & Professional Standards

• Ensures adherence to all applicable regulations standards and company policies; maintains the highest standards of professionalism ethics and compliance.

• Supports and advances compliance program-related initiatives within the function.

Qualifications:

Required:

• Bachelors degree in Engineering is required.

• A minimum of 4 years of related work experience is required.

• Demonstrated experience leading projects of moderate-to-high complexity (cross-functional scope qualification/validation change control).

Preferred:

• Advanced degree (Masters) in Engineering/Science.

• Experience leading qualification/validation (IQ/OQ/PQ) and change control from strategy through closure in regulated environments.

• Demonstrated experience applying statistical tools/experimental design (DOE) and continuous improvement methodologies (Lean/Six Sigma).

• For packaging assignments: demonstrated knowledge/experience with sterile barrier packaging systems and applicable standards/test methods (e.g. ISO 11607 ASTM/ISTA); experience supporting audits in functional area.

• For materials/supplier assignments: demonstrated materials science expertise (e.g. polymers) supplier qualification experience and material characterization methodology experience.

• Proficiency with standard office tools (Excel/PowerPoint/Project as applicable) and familiarity with statistical analysis software (e.g. JMP/Minitab) preferred.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource. If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment as well as get a parents consent for the background check

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