Job Title: Manufacturing Science Specialist
Job Overview:
This is a fantastic opportunity to gain experience in Ireland's leading aseptic manufacturing plant.
The role will be responsible for supporting activities related to the Forensics and Defects group operating within the Commercial Attribute Science team as outlined below.
* Forensics & Defects activities involving forensic identification of Drug Product defects
* Maintenance and production of extensive defect panels used to support automated and manual visual inspection of vial (liquid / lyophilised) and syringe packaged drug products
You will have proven experience acquired in the Pharmaceutical Industry, possess a right-first-time mindset, be a team player, have excellent communication skills and focus on delivering customer needs.
The successful candidate will also have a strong understanding of Data Integrity principles, Quality and Compliance in the laboratory as well as good presentation/influencing skills.
The Manufacturing Science Specialist will lead/assist forensic investigation and identification of defects arising from drug product manufacture and write up of these investigations to cGMP standards.
Be accountable for the maintenance, distribution and upkeep of extensive defect panels used for the set-up, training and characterisation of automated / semi-automated / manual finished drug product visual inspection equipment.
Act as support for the Attribute Sciences function on cross-functional teams/programs.
Timely documentation of Analytical data in the electronic notebook system.
Understanding of data flow in laboratory systems and data integrity.
Participate in the peer review of analytical data.
Compliance with Standard Operating Procedures for the Attribute Sciences Laboratory.
Ensure the laboratory is operated in a safe and environmentally friendly manner.
Ensure ongoing compliance with phase-appropriate GMP, including compliance within the LMS training system.
Ensure high levels of Laboratory housekeeping are maintained including inventory control of samples and consumables.
Ensure timely completion of Laboratory Investigations, Deviations, PMAFs
Participate in internal/external audits/inspections as required.
Plan and implement procedures and systems to maximise operating efficiency.
Manage and contribute to the achievements of department productivity and goals.
Engage with the Continuous Improvement Process and MyGreenLab philosophy.
Requirements:
Hold, at a minimum, a third-level qualification (Degree) in Analytical Chemistry/Biochemistry or related discipline.
Have 3-6 years of experience in the Pharmaceutical Industry.
Excellent written and verbal communication skills.
Experience with Regulatory inspections and interaction with inspectors is preferable.
Experience working with teams and influencing decisions.
Skilled in the use of problem-solving tools/techniques.
Experience with developing, validating, troubleshooting, analytical methods.
Understanding of the Change Control and Variation Management Process.
Understanding how the use of statistical tools, such as multivariate analysis, can aid troubleshooting.
Possess key competencies to include planning/organisation, problem-solving, communication, teamwork, flexibility, coaching and motivating.
Package:
Contract role hourly rate €35 - €45 per hour.
Minimum 12-month contract with the possibility of an extension.
On-site expectations: Expectation at the beginning is to be onsite five days a week.
Shift Rate: 20%.
Shift Patterns: Two cycle shifts:
Week 1: 07:00 to 15:00 Mon – Thurs, 07:00 to 14:00 Fridays.
Week 2: 14:30 to 22:30 Mon – Thurs, 13:00 to 20:00 Fridays.
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