Manufacturing Engineer - Biotech, Dun Laoghaire, Dublin

Office/Project Location: Dun Laoghaire

Employment Type: Contract

Work Location: On site

Pay:  €50 - €60 per hour

Experience: 5+ years

Visa: EU passport or Stamp 4 visa required

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 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)

OR

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

Package

Contract role - Hourly rate €50 - €60 per hour

Minimum 12 month contract

Contact

Karen McHugh is the consultant managing this position.

If you are a Manufacturing Engineer interested in roles based in Dublin , you can contact Karen by e-mail at Karen@jobcontax.com Karen or phone 353 1 9696683 for a confidential chat.

JobContax do not send CVs to clients without candidate permission.

With over 50 years of technical recruitment experience, JobContax is the leading recruiter of Manufacturing Engineers in Dublin and Ireland.

Due to the large volume of applications, JobContax may not be able to respond to every individuals

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