Sr Compliance Engineer

Johnson & Johnson Innovative Medicine; Schaffhausen; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Johnson & Johnson is seeking a Compliance Engineer in Process Engineering at the Schaffhausen campus. The role focuses on supporting aseptic fill-finish operations, troubleshooting and documenting deviations, and driving change controls in a highly regulated environment.

You will work with cross-functional teams to evaluate new technologies, lead process improvements and ensure compliance with FDA/Annex 1 guidelines while contributing to a robust quality culture across the facility.

Qualifikationen

• Specifications & design of process equipment and systems in aseptic environment.
• Troubleshoot equipment failures and perform root-cause analysis with corrective actions.
• Support GMP-compliance of facility, utilities and process equipment.
• Write procedures, analyze data and report conclusions.
• Knowledge of HVAC, monitoring and aseptic qualifications.

Aufgaben

• Support the operation of process equipment and production in the Fill & Finish pilot plant.
• Troubleshooting, non-conformance management and documentation with QA.
• Manage change control systems and process improvements.
• Supervise the technical order system with maintenance and services.
• Train employees and evaluate new technologies for aseptic environment.
• Collaborate across engineering functions locally and globally.

Kenntnisse

Agile Decision Making

Coaching

Critical Thinking

Engineering

Problem Solving

Tools

SAP PLM

Jobbeschreibung

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

Compliance Engineer, Process Engineering (m/f)

Main Task

• Support the operation of the process equipment and production operation at the technical level in the Fill & Finish pilot plant
• Troubleshooting, rectification and documentation (troubleshooting, non-conformance management) in collaboration with production personnel, equipment suppliers and quality assurance
• Management of technical change and optimization processes (change control) systems and processes
• Supervision of the technical order system in cooperation with mechanics and Technical Services
• Instruction and training of employees on system and process level. Support in the evaluation and qualification of new technology-platforms/processes in the aseptic environment
• Cross-cutting project collaboration with other engineering functions at the local campus level and in the global engineering environment

Your profile

• Specifications & design of process equipment and systems in the aseptic environment.
• Troubleshoot equipment failures and define optimization and / or changes to existing equipment. Root-cause analyzation , definition of corrective actions and follow-up of implementations.
• Building experience in process & facility engineering, support GMP-compliance of facility, utilities and process equipment (e.g. COC, events, deviations, NC, qualification, support validation, ... )
• Write procedures, protocols, analyse data and write summary conclusions in reports.
• Building experience and knowledge of HVAC, certification, monitoring - Additional experience in the aseptic field is welcome
• Identify projects, create project plans and participate in their implementation. Perform evaluations to drive efficiency and business results.
• Overall understanding of project budgeting processes and systems.
• Understanding of the own role and the role of the department within the broader organization (CSC/DPDS/IMSC).
• Readiness to lead a project team.
• Provides an opportunity to explore process proof-of-principles to build up of knowlage for commercial process. Plans, coordinates and oversees validation operations, including scale up and optimization processes, equipment assembly, in process sample analysis, use of reactors, and preparation of compliance documents.
• Evaluate analytical results to maintain and improve the quality of batches.
• Propose and determine new or improved technologies to enhance product quality, manufacturing cost efficiencies, personnel safety and regulatory compliance.
• Strong knowledge of aseptic fill finish and Annex 1/FDA compliance with all related regulatory & guidelines to translate in a technical solution
• Bilingual German & English
• 4-6 years’ of experience in the pharmaceutical/foot/chemical environment

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