Senior Manufacturing Specialist

Posted 07 June 2022
SalaryNegotiable
LocationDublin
Job type Contract
DisciplineScience CareersEngineering Careers
ReferenceBBBH532292_1654674057

Job description


Title: Senior Manufacturing Specialist
Location: Dun Laoghaire
Summary:
Our Client is seeking a Senior Manufacturing Specialist (Investigation Lead) who 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:

Responsibilities:
* 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

Qualifications and Experience:
* Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (i.e. 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 (i.e. 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
* 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

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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.