PE Global is currently recruiting for a Visual Inspection Engineer for a leading pharmaceutical clients based in Sligo
This is an initial 12-month contract position.
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.
Essential 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/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, Lyophilization, sterilization operations preferable.
* Experience in clean utilities is desirable.
Interested candidates should submit an updated CV.
Please click the link below to apply, or alternatively send an up to date CV to rebecca@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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