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  • Job reference: RMS0227651

Lyophilization Engineer

  • Sector: Petrochemical & Chemical
  • Location: Dundalk, Louth
  • Job type: Permanent
  • Date posted: 05/10/2020
  • Duration: permanent
  • Time left:
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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 in facilities across Europe, 2 brand new purpose built sites and the acquisition of an established production facility, this innovative and forward thinking pharmaceutical are looking for the top talent in engineering, science and commercial to join their quest in becoming a global leader.

Technology and drug development has seen 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. Knowledge and experience is even more valuable to the public as well as businesses who are trying to make a difference, and our client is certainly one of knows.

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

Involve in the manufacturing process design, construction of facility, co-leading C&Q, support on PQ, site operation, PEV, calibration activities.
 Involve in the lyophilization production activities.
 Plan and organize GMP/EHS training for group members.
 Assign works to each member to fulfill the needs of production and equipment management.
 Follow-up training and the qualities of operator, complete required skill trainings for each individual according to set training module.
 Participate in checking and arranging the document.
 Be responsible for assisting in the cleaning and maintenance including equipment in the area.
 Be responsible for recovery and distribution.
 Be responsible for executing 5S in the area.
 Support validation in the area.
 Participate in drafting and revising the document meeting cGMP.
 Coordination and onsite support on preventative maintenance and repairing.
 Coordination and onsite support on instrument calibration.
 Maintenance on equipment status labeling.
 Be responsible for the shipping and locating of facilities and equipment in the area.
 Introduction new facilities.
 Change control compiling and implementation.
 Deviation investigation.
 Department fixed assets management.
 Prompt repair machine breakdown.
 Continuously improve the performance department facilities.
 Ensure data integrity of all facilities.

 Minimum 6-8 years working in a cGMP biological or vaccine manufacturing environment with previous experience managing subordinates and/or leading project teams./or leading project teams.
 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.

EDUCATION (Indicate the mini(Indicate the mini.. requirement & preferred discipline):& preferred discipline):
 BS/MS with major in Biology, Chemistry or Pharmaceutical Engineering or related Science or Engineering major or person 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, 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

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.

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