MSAT Process Engineer W&L

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Job Description:

A preferred candidate has been identified for this role

Essential Job Duties and Responsibilities

The MSAT 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 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:

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

The anticipated pay ranges for additional locations are:

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.