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.