MSAT Sr Process Engineer W&L

Posted 7 Days Ago
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Geel, BEL
In-Office
73K-115K Annually
Senior level
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
Senior MSAT Process Engineer responsible for material/packaging qualification, process validation/verification, continuous process verification, process improvements, technology deployment (PAT, digitalization), regulatory inspection support, and cross-functional project leadership for API manufacturing and NPI/LCM activities.
Summary Generated by Built In

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:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Geel, Antwerp, Belgium

Job Description:

Essential Job Duties and Responsibilities

The MSAT Sr. Process Engineer W&L is a member of the MSAT Team with the dedicated focus on:

  • Weighing and Logistics area and the material, packaging and consumables qualification
  • Process Validation/Verification
  • Cost improvements and Process improvements
  • Standards and new technology deployment (e.g. PAT, digitalization,…)

The Sr. Process Engineer is a key contributor to NPI / LCM, process improvement initiatives and technology deployment on the site. The level of contribution in these areas and the complexity of the assigned projects is dependent on the education and/or experience level of the engineer and is reflected in the seniority title: regular, senior, staff, principal or senior principal engineer.

 

Main Duties / Additional Duties / Sphere of authority

Manage material, packaging and consumables qualification,

  • Partnering with Operations on Project Oversight of projects assigned as well as day to day support (e.g., investigations, escalations). 
  • Partnering with Product Technical Owners, TLI’s and BUs on project priorities.
  • Monitor process and product performance, based on Continuous Process Verification (CPV) 
  • Review / approve Product Quality Reviews (PQR) 
  • Lead or support complex process investigations or product related technical issues (escalation of quality or compliance events) 
  • Process LCM documentation (including validation protocols and reports, criticality analysis documents, change control)
  • The MSAT engineer can also take the role of an API Technical Owner or Focused Factory Lead or member, both leading or active participating a multi-disciplinary synthesis experts team (the former focusing on long term E2E strategy of the assigned products, the latter on door-to-door robust flow for a product or technology.

Standardization & Innovation

  • Contribute to Standardization initiatives for MSAT
  • Implement Process optimizations and CIP’s (e.g., from improved data analytics)
  • Build technology expertise on current technologies and support evaluation and introduction of new process technologies by participating/leading the shared technology teams for the different area’s (stronghold teams, focus areas, …) and partner with R&D/operations/GET on knowledge sharing.

Inspection Readiness and Execution

  • Technical support in partnership with Quality on any regulatory audits and inspections
  • Being the Spokesperson in Audits internal and external for the MSAT processes
  • Be Local Process owner for material qualification, extractables and leachables, packaging materials

General

  • Lead a group of external experts and support function to deliver on objectives
  • Interacts with local business unit partners: QA, QC, Ops, Planning, GET and EHS
  • Interact with Global MSAT (e.g., with Technical Launch Integrators in the NPI team) 
  • Interact with R&D with regards to NPI introductions, process optimizations and/or investigations 
  • Positive contribution to meet and improve the Site MSAT KPIs 
  • Contribute to the reduction of process related events / deviations 
  • Demonstrates a Credo-based culture aligned around our guiding principles of servant leadership, Faster Forward, innovation, engagement, collaboration and development.

Profile needed for this function

Knowledge

Specific knowledge

  • Master’s Degree or PHD in science, engineering or pharmacy with minimum 2-5 years relevant work experience
  • Strong expertise in pharmaceutical manufacturing processes and products & equipment with focus on API Platform Technology
  • Experience with introduction of pharmaceutical products to manufacturing sites and late state development with working technical knowledge of manufacturing site unit operations.
  • Knowledge of manufacturing site systems and procedures, along with equipment understanding
  • Project management (FPX), organizing, planning and coordination skills
  • Process excellence, lean concepts and tools
  • Business acumen, financials
  • Strong knowledge of Quality & Compliance / regulatory requirements (GMP/EH&S) especially for API Technology Platform
  • Adhere to applicable cGxP’s and procedures 

·        Report incidents and deviations 

·        Propose solution to improve compliance with cGMP’s 

·        Adhere to applicable EH&S and procedures

·        Correct use of the available personal and collective protection materials

·        Reporting of (near) accidents, incidents, deviations. Act when violation of EH&S rules is observed and stimulate appropriate behavior 

·        Cooperate on and suggest solutions to improve EH&S

·        Actively participate in PHA/HAZOP meetings providing process expertise 

 

Personal and interpersonal skills / Leadership skills

  • Ability to lead cross functional teams
  • Ability to interact at different levels of the organization
  • Ability to work under pressure, handle conflicting interests, and take decisions
  • Ability to work independently under general direction, having a good sense of prioritization of assigned tasks goals and manage time accordingly.
  • Customer and business focus
  • Drives for innovation and change to ensure competitiveness.
  • Can-do mentality, agility & flexibility to work with stretched goals and deadlines.
  • Willing to place the goals of the team first and work with others towards these goals
  • Communicative / Motivator / Negotiator / assertive person having impact
  • Showing a high sense of responsibility regarding professional activities
  • Problem solving skills and attitude

Personal attitude and mindset

Motivated, self-starter able to work independently with demonstrated problem solving skills.

  • Ability to manage complexity and change.
  • Ability to interact at different levels of the organization.
  • Ability to work under pressure, handle conflicting interests, having a good sense of prioritization of assigned tasks goals and manage time accordingly.
  • Ability to create a result oriented (project) team – for those engineers leading projects.
  • Customer and business focus

Degree

Master or Phd in Science

Languages

Dutch and English (spoken as well as written)

Specific know how of systems

The function holder is acquainted with different data and production systems, such as eLIMS, truVAULT, Trackwise, COMET, PRX, CRB, SAP, PASx



Required Skills:



Preferred Skills:

Agile Decision Making, Coaching, Corrective and Preventive Action (CAPA), Critical Thinking, Emerging Technologies, Issue Escalation, Lean Supply Chain Management, Problem Solving, Process Control, Process Engineering, Product Costing, Product Improvements, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Technical Research, Technologically Savvy, Validation Testing, Vendor Selection

  


The anticipated pay range for this position, in the primary posting location, is:

€72 500,00 - €115 230,00

The anticipated pay ranges for additional locations are:


Belgium – The anticipated base pay range for this position is 72 500,00 – 115 230,00 EUR annualy

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 location’s 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.



Skills Required

  • Master's or PhD in science, engineering, or pharmacy
  • Minimum 2-5 years relevant pharmaceutical manufacturing or process engineering experience
  • Expertise in API platform manufacturing processes, equipment, and unit operations
  • Experience with introduction of pharmaceutical products to manufacturing sites and late-stage development
  • Knowledge of Quality & Compliance and regulatory requirements (GMP, cGxP, EH&S)
  • Experience with process validation, continuous process verification (CPV), and validation documentation
  • Project management skills (FPX), planning, organizing and coordination
  • Process excellence and lean concepts and tools
  • Ability to lead cross-functional teams and support audits/inspections as MSAT spokesperson
  • Proficiency with site systems: eLIMS, truVAULT, Trackwise, COMET, PRX, CRB, SAP, PASx
  • Dutch and English language skills (spoken and written)
  • Participation in PHA/HAZOP and safety/EH&S compliance activities
  • Experience with process optimization, CAPA, investigations and corrective actions
  • Familiarity with PAT and digitalization technologies for manufacturing
  • Business acumen including product costing and financial awareness

Johnson & Johnson Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.

  • Healthcare Strength Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
  • Retirement Support Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
  • Parental & Family Support Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.

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The Company
HQ: New Brunswick, NJ
143,612 Employees
Year Founded: 1886

What We Do

Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines

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