Senior Manufacturing Scientist | Collins McNicholas

Senior Manufacturing Scientist

  • Reference: GY45431
  • Job Type: Permanent
  • Location: Mayo
  • Category: Science, Pharmaceutical & Food

Responsibilities:

• Assist in all aspects of batch manufacturing activities, in accordance with SOPs and batch record instruction for multiple products

• Perform sterile filtration and filter integrity testing.

• Updating / generation of SOPs and manufacturing documentation

• Coordination of calibration / revalidation activities

• Support installation of new equipment as required

• Knowledge of equipment validation and SDLC an advantage. 

• Completion of quality records

• Implementation of product dedicated controls for the Core 1 area

• Support regulatory inspections as required

Skills, Experience and Qualifications:

• MSc degree with three years experience or a degree in a Science or Engineering discipline with five or more years of applied experience in Pharma/ Biologics.

• Understanding of autoclave sterilisation, depyrogenation, filter integrity testing essential

• Experience with commercial & / or clinical manufacture.

• Excellent technical writing and communication skills.

• Proven ability to problem solve.

• Must be a self-starter with a pro-active approach

• Experience with interacting in project teams.

• Experience with single use technologies

• Knowledge of lyophilisation and freeze dryer operations

• Flexibility of working hours may be required

• Experience with GMP regulatory inspections

• Good time management and organisational skills

• Understanding of autoclave sterilisation, depyrogenation, filter integrity testing essential

• Understanding of aseptic practices in clean room environment

• Understanding of Single Use Technology and Single use system validation.

• Working knowledge of Quality Management System (QMS)

• Knowledge of clinical development phases

• Understanding requirements of cross contamination controls in multi-product facility

• Working knowledge of Lean Six Sigma, yellow/green belt desirable.

For a confidential discussion and more information on the role/company please email your CV to: amy.oneill@collinsmcnicholas.ie


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Amy O’Neill

Contact Consultant

  • Amy O’Neill
  • Recruitment Consultant
  • 091706718
  • Connect with Amy

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