Process Development - Senior Engineer - Biopharma

Location
Dublin South
Salary
Competitive - Contractor or Temporary - Initially
Posted
18 December 2018
Closes
16 January 2019
Ref
AAPDSEB
Position / level
Professional
Contract Type
Permanent
Hours
Full Time

Job Description

Looking for a process development/improvement senior engineer to join the ranks of a biopharmaceutical client in Dublin South. 

This is an exciting opportunity, with an initial offering of either contract or temporary placement - with a view to permanency subsequent to finishing an initial placement period. You would ideally be very experienced particularly within the packaging side of syringe and vial sterile manufacturing.

Job Daily Tasks:

  • Oversee packaging activities with respect to New Product Introductions
  • Serve as process development packaging subject matter expert.
  • Troubleshooting Final product technologies.
  • Participate and lead investigations with a view to investigating deviations and raising CAPA actions.
  • Develop IOQs and PQs
  • Oversee design transfer.
  • Ensure that all activities adhere to GMP, FDA and EMEA standards.
  • Participate in development and review of process validation, process characterization, process qualification and quality based documentation.
  • Act as site representative within the companies global process development team.

Job Essentials

  • GMP Experience
  • Experience in medical devices, pharmaceutical, or biopharmaceutical based similar roles.
  • Experience of Process Characterisation, Technical Transfers and Validation activities.
  • Working knowledge of quality systems, and the processes associated with packaging of Drug Final Product and associated Validation activities.

Salary

On initial placement, there are two options, of either contract work or temporary staff based remuneration. Temporary staff hourly pay of up to €48 per hour, whilst contracting rates would include a maximum of €58 per hour.

Contact

If you are interested in this role apply below. I also have more senior or indeed junior roles within QC, QA, QP, Validation, CQV, and other areas of pharmaceutical, medical device, and biologics companies. Send me an email to schedule a confidential chat (014744692) - to andrius@sigmar.ie

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