Shift Process Development Scientist

Process Development Scientist - Dun Laoghaire, DublinOffice/Project Location:Dun Laoghaire, DublinEmployment Type: ContractWork Location:  On Site Lab basedPay: €35 - €45 per hourExperience: 3+ years Visa: EU passport or Stamp 4 visa requiredOur client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoghaire, South Dublin. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment. This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.This role will be responsible for supporting activities related to the Forensics and Defects group operating within the Commercial Attribute Science / CAS team as outlined below.Forensics & Defects activities involving forensic identification of Drug Product defects and maintain and produce 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, have a right first-time mindset, be a team player, have excellent communication skills and be focussed on delivering on our 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.Leads / assists 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/programsTimely 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 , PMAFsParticipate 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.RequirementsHold , at a minimum a third level qualification (Degree) in Analytical Chemistry/ Biochemistry or related discipline.Have 3-6 years of experience in the Pharmaceutical IndustryExcellent written and verbal communication skillsExperience with Regulatory inspections and interaction with inspectors is preferable.Experience working with teams and influencing decisions.Skilled in the use of problem-solving tools/techniquesExperience with developing, validating, troubleshooting, analytical methods.Understanding of the Change Control and Variation Management ProcessUnderstanding 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.PackageContract role - Hourly rate €35 - €45 per hourMinimum 12 month contract with the possibility of an extension. Onsite expectations: Expectation at the beginning is to be onsite five days a week because they’re ramping up. They will be ramping up training and ensure that the CW has all the tools necessary to operate independently. This will be the case for the initial first six-months – to be present in the lab. When the CW is working autonomously, there could be an opportunity to work one day a week from home. This will be for when the individual needs to write up a report and stuff like that.Shift Rate: 20%Shift Patterns: Two cycle shifts:Week 1: 07:00 to 15:00 Mon – Thurs, 07:00 to 14:00 FridaysWeek 2: 14:30 to 22:30 Mon – Thurs, 13:00 to 20:00 Fridays