Biotech Manufacturing Investigation Lead Specialist - Dun Laoghaire, Dublin
Office/Project Location: Dun Laoghaire, Dublin
Employment Type: Contract
Work Location: Site Based / Hybrid
Pay: €50 - €60 per hour
Experience: 7+ years
Visa: EU passport or Stamp 4 visa required
Biotech Manufacturing Investigation Lead Specialist - Dun Laoghaire, Dublin
Our 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 investigations
Drive improvements to the investigation process
Present investigations to regulatory inspectors and internal auditors
Clearly communicate investigation progress to impacted areas and leadership
Coordinate and lead cross-functional teams through complex investigations, and complete tasks on-schedule.
Project management of the investigations end to end
Present 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 process
Requirements
Bachelor's Degree in Science or Engineering
5+ 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 operations
Experience with compliance, problem-solving, root cause analysis, critical thinking, project management, and quality systems.
Experience leading complex investigations
Experience participating in and leading cross-functional teams
Experience in managing multiple, competing priorities in a fast-paced environment
Experience presenting to inspectors during regulatory inspections and internal audits.
Excellent technical writing
Excellent presentation and communication skills, ability to communicate and collaborate with technical and management staff
Ability to be flexible and manage change
Package
Contract role - Hourly rate €50 - €60 per hour
Minimum 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.