Accessibility Links
  • Job reference: RMS0227650

Filling Engineer - Drug Production

  • Sector: Healthcare & Medical
  • Location: Dundalk, Louth
  • Job type: Permanent
  • Date posted: 30/09/2020
  • Duration: permanent
  • Time left:
    d h m s
Send jobs like this to my email    What's this?

A rapidly growing R&D pharma technology business are continuing their meteoric rise of becoming a global force in technology, contract manufacturing and drug production. With a recent $500 million investment in facilities across Europe, 2 brand new purpose built sites and the acquisition of an established production facility, this innovative and forward thinking pharmaceutical business are looking for top talent in engineering, science and commercial positions to join their quest in becoming a global leader.

Technology and drug development has seen an astronomical increase in hedge funds and private investments over the past 5 years, and with the demand increasing for positive human health, we are looking now more than ever to companies for help and support in drug development and drug production, and our client is working to lead the way in this field.

With the investment of new sites and expansions comes a requirement for talented individuals to join them and share their knowledge, and in this case we are looking for a Filling Engineer.

 Involve in the manufacturing process design, construction of facility, co-leading C&Q, support on PQ, site operation, PEV, calibration activities.
 Responsible for the related aseptic filling production activities.
 Responsible for room changeover and room release activities
 Participate in the cleaning and maintenance equipment.
 Responsible for receipt, issue, return and retirement of modules in DP manufacturing facility.
 Responsible for making manufacture schedule, workforce management and production process information Statistics.
 Responsible for WFI/steam coordination.
 Responsible for facility shutdown, facility transform and fumigation.
 Responsible for EHS activities.
 Participate in drafting and revising the document meeting cGMP and handle relevant SOP, Change control, and CAPA.
 Collaborate with QC & QA groups to ensure GMP compliance, manage deviation investigation and CAP Implementation, and support client auditing a nd agency inspections.
 Schedules and/or delivers training to manufacturing personnel to ensure staff can perform manufacturing operation safely and compliantly.

 Minimum 6-8 years working in a cGMP biological or vaccine manufacturing environment with previous experience managing subordinates and / or leading projects
 Must be a strong leader able to adapt to daily challenges of manufacturing work environment while maintaining positive and productive attitude and fostering this attitude among subordinates.
 Must be quality focused with knowledge and understanding of cGMP quality systems and how they apply to manufacturing operations.
 Must possess good interpersonal skills and the ability to communicate well, both verbally and written.
 Excellent written and oral presentation skill,
 Detail-oriented organizational skill,
 Have good communication and cooperation ability and can cooperate many departments to complete deviation investigation.

 BSc/MS with major in Biology, Chemistry or Pharmaceutical Engineering or related Science or Engineering major or person with equivalent experience. with equivalent experience.

 Experience in working with the cross-functional teams.
 Experience in troubleshooting and investigation of the critical deviation ,and making the risk analysis on the development, development, technical transfer and process validation.technical transfer and process validation.
 Experience in the large-scale chromatography, centrifuge and depth filtration harvest, ultrafiltration/diafiltration, and viral inactivation and removal viral inactivation and removal..

About Fircroft:
Fircroft has been placing people in specialist technical industries for over 50 years, focusing on mid to senior level engineers for contract and permanent roles worldwide. By applying for this job you give consent for Fircroft to contact you, via email & telephone, to discuss your application along with future positions and Fircroft's services.

Fircroft is registered as a Data Controller with the Information Commissioner as required under the General Data Protection Regulation 2016/679. Fircroft will only process your personal data for the specific purposes of managing your application.

Back to Top

By clicking "Save" you consent to
receiving matching jobs based on the
job/page you are viewing by email from
Fircroft, as detailed in our privacy policy
Fircroft would like to keep you up to date with our latest company updates via email. Occasionally Fircrofts marketing may contain 3rd party or affiliate information, however we will not share your personal data with any 3rd parties without your consent. From time to time, we might contact you to get your views on the service you have received. To help you get the best out of Fircroft, we may personalise them based on your location and how you use
Fircroft would like to keep you up to date with the latest company updates and vacancies via SMS / Text messages
Your consent options above means that Fircroft cannot contact you about any new or alternative career vacancies. If you want Fircroft to only contact you about the role(s) you have applied for please continue, however if you would like to be considered for other positions please allow us to contact you by changing one or more of the above consent.