Senior Manufacturing Specialist

Senior Manufacturing Specialist –Team Horizon
 
Team Horizon currently has an exciting opening for a Senior Manufacturing Specialist to work on our client site in Dublin. The Senior Manufacturing Specialist will also be involved in applying process, quality, compliance, and analytical knowledge.
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 bedoing:

• Manage deviation investigations, including establishing investigation teams, leading root cause analysis, development of CAPAs, completing product impact assessments and writing 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) or Associate's Degree in Science or Engineering and 8+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality) 10+ years directly related experience in a biotech/pharma manufacturing or manufacturing environment.


• 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, 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 and presentation and communication skills, ability to communicate and collaborate with technical and management staff


• Ability to be flexible and manage change