MSAT Process Engineer W&L

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Job Function:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Geel, Antwerp, Belgium

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 st