Description
PROCESS ENGINEER / TECHNICAL OPERATIONS SUPPORTTO is supporting the Parenterals platform in the client Supply Chain, focused on the manufacture of Large Molecule / Biopharmaceutical products for applications in oncology and immunology.
The main responsibilities of the Global TO team:
* Tech Transfer (TT) for New Product Introduction (NPI) for Drug Product manufacturing for both internal and external JSC manufacturing facilities, but mainly focused on the client site and regional Contract Manufacturing Organizations (CMO's).
* Life cycle management of Drug Product manufacturing, for both internal and external JSC manufacturing facilities, again mainly focused on the client site and reginal CMO's.
* Support for the Parenteral Centre of Innovation (PCI) and taking and an active role in global alignment and standardization of processes and procedures.
* Providing active support for products sourcing, Business Case development and general technical / operational programs.
The successful candidate will - under supervision - take over part of the responsibilities in the areas of:
1) Manage Product Transfer / Product Introduction
- Perform Technical Assessments, Process fit to plant, Risk Assessments;
- Interface with manufacturing organization and the Process Development (PD) organization;
- Interface with QA, RA, Engineering and other key business partners to ensure flawless process transfer;
- Equipment Performance Qualification, Cleaning Validation;
- Project Evaluation, lessons learned and hand-over.
2) Product technical life cycle management:
- Provide manufacturing technical support, JSC technical expert;
- Monitor technical process and product performance, develop models and metrics to ensure production consistency, and regulatory compliance;
- Lead or support complex failure investigations (escalation of quality or compliance events);
- Provide technical support, in partnership with Operations and Quality for regulatory audits and inspections;
- Continued Process Verification, Process and Cleaning validation.
Details and extend of the work scope to be defined based on background and experience.
The support may also include work for PCI and/or standardization.
Languages:
- English: fluent (written and spoken).
- German - written or at least spoken.
Qualifications
- Minimum a Bachelor's degree in a numerate discipline - engineering or science;
- Experience in a pharmaceutical environment.Preferably 5+ years.
- Expertise in pharmaceutical manufacturing processes, products and equipment.
- Knowledge of Quality & Compliance, GxP systems, and knowledge of validation.
- Experience working or leading and influencing in a matrix type organization.
- Experience in project management (FPX or similar), organizing, planning and coordination skills.
- Knowledge of regulatory requirements (GMP/EH&S).
Michael Bailey International is acting as an Employment Business in relation to this vacancy.