Senior Compliance Engineer, Process Engineering

Johnson & Johnson is hiring a Senior Compliance Engineer, Process Engineering. Level rates it ; you can apply on Johnson & Johnson.

Level's read on this job

Level rates this role Little AI ●○○○: aI is not part of the work.
The posting mentions compliance engineering, process engineering and gmp among its tools and skills.
Level classes it as a senior role.
Johnson & Johnson has 1,700+ other open roles on Level.

AI in this role

Manage engineering compliance, equipment qualification, troubleshooting, and validation for aseptic process engineering.

compliance-engineeringprocess-engineeringgmptroubleshootingroot-cause-analysisequipment-qualification

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 jnj.com.

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.

Job Function:

R&D Product Development

Job Sub Function:

R&D Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Schaffhausen, Switzerland

Job Description:

Senior Compliance Engineer, Process Engineering (m/f)

Main Tasks

The Senior Compliance Engineer, Process Engineering, is responsible for Engineering and Qualification; support Validation on process equipment, utilities & facilities and computerized systems in CM&T F2P2.

Provide technical support for operation of process equipment and production in the Fill & Finish pilot plant.
Lead troubleshooting, corrective action and documentation efforts for technical issues and non-conformances, collaborating with production teams, equipment suppliers and Quality Assurance.
Manage technical changes and optimization initiatives through the change control process.
Oversee the technical work order system in cooperation with mechanics and Technical Services.
Deliver training and instructions to operators and staff at system and process level.
Support evaluation, qualification and implementation of new technology platforms/processes in an aseptic environment.
Collaborate across engineering functions locally and within the global engineering organization on cross-functional projects.

Your profile

Proven experience specifying and designing process equipment and systems for aseptic environments.
Strong troubleshooting skills: perform root cause analysis, define corrective actions and ensure implementation and follow-up.
Experience in process and facility engineering with hands-on support for GMP compliance of facilities, utilities and process equipment (e.g., change controls, deviations, NCs, qualifications, support for validation).
Experience writing procedures and protocols, analysing process data and producing clear technical reports with conclusions and recommendations.
Knowledge of HVAC systems, certification and monitoring; previous aseptic-fill/sterile manufacturing experience is an advantage.
Ability to identify improvement projects, create project plans and participate in delivery to drive efficiency and business outcomes.
General understanding of project budgeting and basic financial processes.
Awareness of the department’s role within the broader organization (CSC/DPDS/IMSC) and readiness to lead project teams.
Experience planning and coordinating validation and scale-up activities, equipment assembly, in-process sampling, reactor use and preparation of compliance documentation.
Ability to evaluate analytical results to maintain and improve batch quality.
Propose and implement new or improved technologies to enhance product quality, manufacturing cost-efficiency, personnel safety and regulatory compliance.
Solid knowledge of aseptic fill-finish operations and regulatory requirements (Annex 1 / FDA guidance) and the ability to translate these into technical solutions.
4–6 years’ experience in the pharmaceutical, food or chemical industry.
Fluent in German and English (written and spoken).

Required Skills:

Preferred Skills:

Agile Decision Making, Coaching, Critical Thinking, Emerging Technologies, Engineering, Problem Solving, Process Control, Process Engineering, Process Improvements, Product Costing, Product Improvements, Research and Development, SAP Product Lifecycle Management, Situational Awareness, Technical Research, Technical Writing, Technologically Savvy, Vendor Selection

How we rate this

Senior Compliance Engineer, Process Engineering at Johnson & Johnson rates 0 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.

Classification

Little AI. AI is not part of the work.

●●●● Builds AI80 to 100
●●●○ Works on AI60 to 79
●●○○ Uses AI40 to 59
●○○○ Little AI0 to 39

Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.

Key facts

Senior Compliance Engineer, Process Engineering is an open job at Johnson & Johnson.
Level rates this role AI Level 1 of 4: Little AI.
The role is based in Schaffhausen, Switzerland.
The job was posted on September 29, 2026.
Seniority: senior.
Applications are handled by Johnson & Johnson. Apply on Johnson & Johnson

Prepare for this job

Built from this posting and from similar jobs on Level.

Skills and AI tools this role asks for

Compliance EngineeringProcess EngineeringGmpTroubleshootingRoot Cause AnalysisEquipment Qualification

Questions you could be asked

Tell me about a project where compliance engineering was part of your work. What did you do?
Tell me about a project where process engineering was part of your work. What did you do?
Tell me about a project where gmp was part of your work. What did you do?
Tell me about a project where troubleshooting was part of your work. What did you do?
Tell me about a project where root cause analysis was part of your work. What did you do?

Adapt your resume

List these exact terms on your resume: Compliance Engineering, Process Engineering, Gmp, Troubleshooting, and Root Cause Analysis. An applicant tracking system matches the wording, not the idea.
Attach one line of real, concrete experience to at least one of them. A tool named with nothing behind it rarely survives a human read.

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