Global Principal Engineer Small Molecules Platform

☞ Johnson & Johnson

看过: 180

更新日: 16-11-2025

位置: Geel Antwerp

类别: 高科技 IT-软件

行业: Medical Equipment Manufacturing Hospitals Health Care Pharmaceutical Manufacturing

工作类型: Full-time

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工作内容

Global Principal Engineer API LCM Small Molecules Platform TechOps

The Principal Engineer SM API LCM provides technical support and leadership to the global technical Lifecycle Management (LCM) of our Small Molecule Active Pharmaceutical Ingredients (SM API) portfolio in the Small Molecules Technical Operations platform. The portfolio includes both internally manufactured API’s and API’s sourced from external manufacturers and generic suppliers. The Principal Engineer partners with key stakeholders and will lead cross-functional teams to maintain base business activities, to support investigations and to deliver on LCM projects from a technical focus area. The Principal Engineer participates in the end-to-end technical review and governance processes for the product portfolio in scope of Technical Operations.

Key Responsibilities

Base Business Activities
  • Coordinate regular end-to-end technical reviews of products in scope of Technical Operations and using CPV, PPQS, PQR and other tools and programs in place.
  • Ensure criticality analysis and control strategies are up to date.
  • Provide technical support to the change control process.
  • Partner with PM/VCM to align on product strategies from a technical focus area.
  • Provide technical support to regulatory filings and respond to questions from HA’s.

Investigations
  • Provide technical support to issue escalation and investigation processes.
  • Follow-up on CAPA definition and implementation in technical focus area.

LCM Projects
  • Identify opportunities for process and product improvements in the technical area.
  • Provide technical support to business case development and definition of upcoming projects.
  • Support or lead the execution of LCM projects from a technical focus area (qualification of new API supplier; tech transfer; product delisting or divestment; process optimization; etc.).
  • Support or lead API comparability activities.

Technical Ownership
  • Globally own API for assigned products.
  • Provide API technical expertise for assigned products.
  • Act as single technical Point-of-Contact (POC) for assigned products for key stakeholders and customers.
  • Establish and maintain a strong end-to-end technical connection with DP technical owner and DP sites.
  • Work with group of technical experts and SME’s in JSC and DPDS on technical issues.
  • Represent Technical Operations on Value Chain Teams (VCT), Issue Management Teams (IMT) etc.

Qualifications

Qualification:
  • A master’s degree in engineering or science.

Technical Skills And Competences
  • 8-10 years of experience in similar role in technical environment.
  • Understanding of the pharmaceutical business and industry.
  • Experience in chemical manufacturing and technologies.
  • Project Management skills (FPX certification preferred).
  • Strong knowledge of Quality, GMP and EHS requirements.
  • Knowledge of Regulatory environment.
  • Strong data analytical skills. Statistical skills will be considered as an asset.

Personal Skills And Competences
  • Ability to lead cross-functional teams.
  • Ability to manage complexity and change.
  • Strong communication skills.
  • Ability to influence.
  • Ability to work independently under general direction.
  • Strong customer and business focus.

Other
  • Fluent in written and spoken English.
  • Primary location is Geel site in Belgium.
  • Position requires availability to travel to domestic and international destinations, about 10% of the time.

Primary Location

Belgium-Antwerp-Geel-

Organization

Janssen Pharmaceutica N.V. (7555)

Job Function

R&D

Requisition ID

2206039185W

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最后期限: 31-12-2025

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