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Technical Engineer - Process/Validation

Eingestellt von Quanta Consultancy Services

Gesuchte Skills: Support, Engineering, Engineer

Projektbeschreibung

ROLE - TECHNICAL ENGINEER - PROCESS/VALIDATION
LOCATION - CO. CARLOW, IRELAND
TYPE - 11 MONTH CONTRACT

SUMMARY:
One of our key clients, a global Pharmaceutical leader, is looking for a Technical Engineer to be responsible for providing process, technical and validation support including ongoing support of manufacturing processes and support for new product introduction. Accountable for co-ordination, design and execution of equipment qualification and validation as required.

KEY RESPONSIBILITIES:

- Serve as technical support for manufacturing and new product introductions through.
- Design/Author/Review/Approve/Execute process development studies in support of new product introduction and ongoing manufacturing support.
- Provide technical input by authoring/reviewing/approving investigations.
- Execution of equipment/qualification validation programs; including requalification and re-validation
- Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process
- Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis
- Support continuous improvement through Lean Six Sigma methodologies.
- Leading and active participation in projects, system failure investigations and investigation reports,
- Execution/development of change controls
- Contribution to Kaizen events as appropriate.
- Perform root cause analysis of system failures, substandard
- performance, using standard tools and methods, to resolve machine and system issues eg FMEA, Fishbone diagrams, 5 why's etc.;
- Implement subsequent corrective action through the change management system.
- Serve as technical engineering representative for internal technical group discussions and represent technical Operations at global technical forums.
- Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.

KEY REQUIREMENTS:

- Minimum qualification B.Sc. or M.Sc./M.Eng Degree in Science, Chemical or Biopharmaceutical or equivalent discipline
- Experience in a cGMP biopharmaceutical processing/sterile filling design, start-up or manufacturing environment
- Excellent report/standard/policy writing skills required
- Experience in process engineering and technologies pertinent to Formulation and Sterile Filling Operations including Media Prep, Buffer.
- Prep, Adjuvant Manufacture, Formulation, Vial and Syringe filling and automated visual inspection is desirable.
- Experience in both equipment and process validation experience is desirable.
- Knowledge of the automation control platform is desirable.
- Knowledge of FDA and EU regulations pertinent to aseptic processing, in particular, is desirable.
- Report, standards, policy writing skills required.
- Lean Six Sigma and change control methodology experience desired.

Projektdetails

  • Einsatzort:

    Carlow, Irland

  • Projektbeginn:

    asap

  • Projektdauer:

    Initially 12 month Contract

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Quanta Consultancy Services