Visual Inspection Specialist

3 days ago

Sligo, Sligo, Ireland beBeeInspection Full time €40,000 - €60,000

The Job:

Visual Inspection Engineer

This role involves supporting the operations of a biologics manufacturing plant in Sligo.

We are recruiting for a Visual Inspection Engineer to join our team on an initial 12-month contract basis.

Key Responsibilities:

  • To work collaboratively as part of a team to support Visual Inspection operations in line with all safety, regulatory and organizational requirements.
  • Developing and modifying procedures as needed to support the manufacturing operation.
  • Participating in process, equipment, and facilities validations efforts and projects implementations.
  • Reviewing and approving process related commissioning, qualification and validation protocols for completeness and accuracy.
  • Executing protocols in a timely manner to meet project schedule requirements.
  • Participating and leading (as required) Process FMEAs for Visual Inspection.
  • Establishing, leading and optimizing the process for certification of technicians for visual inspection.
  • Establishing and maintaining the defect library.
  • Establishing and executing the process for the trending of Visual Inspection Defects.
  • Ensuring all Site Visual Inspection procedures are aligned with Global Guidance Documents and Regulatory Requirements.
  • Providing technical input to guide the development of SOPs for Visual Inspection.
  • Leading manufacturing and validation activities during project life cycle.
  • Coordinating with internal/external stakeholders for the evaluation of particles/defects.
  • Supporting technical transfers for future product introductions to the site.
  • Investigating process exceptions or malfunction incidents affecting the process.
  • Liaising with Internal/External Engineering Personnel and Internal/External Quality personnel as required.
  • Supporting the Production Team in ensuring that manufacturing process is enabled and maintained to meet the output and yield requirements.

Requirements:

  • A relevant third-level qualification in an engineering, science or technical discipline (Degree Level or Masters Preferable).
  • At least three (3) years of total combined experience in Technical/Operations/Quality or equivalent in a Pharmaceutical and Health Care Organization.
  • At least three (3) years of experience in the manufacturing environment of a biotechnology, pharmaceutical or health care plant.
  • Previous experience in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, fill finish, Lyophilisation, sterilisation operations preferable.
  • Experience in clean utilities is desirable.

About Us:

We are committed to excellence in our operations and strive to maintain the highest standards in quality and safety.

Our goal is to provide a safe and healthy working environment for our employees.

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