Manufacturing Specialist (Investigations & Deviations)

Team Horizon is seeking a Specialist Manufacturing for our client based in Dublin. 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. This role is hybrid with a three day onsite and two days from home model. Flexibility is required to come on site.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.


• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.


• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• 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

What you need to apply:

• Bachelor's Degree in Science or Engineering and 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