15h Left Technical Specialist – Bioassay

2 weeks ago

Cork, Cork, Ireland PE Global (UK) Full time
The role:

PE Global is currently recruiting for a Visual Inspection Engineer on behalf of a leading biologics company based in Sligo. This is an initial 12-month contract role.

Responsibilities:

- To work as a team member to support Visual Inspection operations in line with all safety, regulatory and organizational requirements.
- Develop and modify procedures as needed to support the manufacturing operation.
- Participate in process, equipment, and facilities validations efforts and projects implementations.
- Review and approve process related commissioning, qualification and validation protocols for completeness and accuracy.
- Execute protocols in a timely basis to meet the project schedule requirements.
- Participate and lead (as required) Process FMEAs for Visual Inspection
- Establish, Lead and Optimize the process for certification of technicians for visual inspection.
- Establish and maintain the defect library.
- Establish and execute the process for the trending of Visual Inspection Defects.
- Ensure all Site Visual Inspection procedures are aligned with Global Guidance Documents and Regulatory Requirements
- Provide Technical Input to guide the development of SOPs for Visual Inspection.
- Leadership of manufacturing and validation activities during project life cycle.
- Coordination with internal/external stakeholders for the evaluation of particles/defects
- Support of technical transfers for future product introductions to the site.
- Investigate process exceptions or malfunction incidents affecting the process.
- To liaise with Internal/External Engineering Personnel and Internal/External Quality personnel as required
- Support the Production Team in ensuring that manufacturing process is enabled and maintained to meet the output and yield requirements.

Education and Experience:

- 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/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.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland.

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