Biotech Manufacturing Investigation Lead Specialist - Dun Laoghaire, DublinOffice/Project Location:Dun Laoghaire, DublinEmployment Type: ContractWork Location: Site Based / HybridPay: €50 - €60 per hourExperience: 7+ yearsVisa: EU passport or Stamp 4 visa requiredBiotech Manufacturing Investigation Lead Specialist - Dun Laoghaire, DublinOur 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.The Manufacturing Specialist (Investigation Lead) will be primarily responsible for leading investigations for fill/finish/inspection and packaging deviations.
Specialists will also be involved in applying process, quality, compliance, and analytical knowledge to complete the following:Manage deviation investigations, including establishing investigation teams, leading root cause analysis, development of CAPAs, completing product impact assessments and writing comprehensive compliant documentation of all findings.Clear and concise technical writing of complex investigationsDrive improvements to the investigation processPresent investigations to regulatory inspectors and internal auditorsClearly communicate investigation progress to impacted areas and leadershipCoordinate and lead cross-functional teams through complex investigations, and complete tasks on-schedule.Project management of the investigations end to endPresent complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.Build effective relationships across functions.Navigate through ambiguity and provide a structured problem-solving approach.Able to apply inductive and deductive reasoning in the investigation processRequirementsBachelor's Degree in Science or Engineering5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality) Detailed technical understanding of fill/finish operationsExperience with compliance, problem-solving, root cause analysis, critical thinking, project management, and quality systems.Experience leading complex investigationsExperience participating in and leading cross-functional teamsExperience in managing multiple, competing priorities in a fast-paced environmentExperience presenting to inspectors during regulatory inspections and internal audits.Excellent technical writingExcellent presentation and communication skills, ability to communicate and collaborate with technical and management staffAbility to be flexible and manage changePackageContract role - Hourly rate €50 - €60 per hourMinimum 12 month contract with the possibility of an extension.
Onsite Expectations: hybrid role, but the candidate will need a degree of flexibility to come onsite, as this is dependant on the deviation they're working on, as they may end up certain weeks being fully onsite.
In general, you will be on site a couple of days per week, but it could go equally to a 100% for a period of time, depending on the nature of the deviation.
Core hours: 08:30 to 17:00.
We can offer some flexibility in start times, team meetings are at 08:40, which require presence.
Earliest start date we can offer is 07:00, but majority of the team would start around 08:30.