Orion Group Life Sciences is currently recruiting a Visual Inspection Engineer on behalf of our multinational biopharmaceutical client based in Sligo for a 12-month contract.
Responsibilities:
* Support Visual Inspection operations, ensuring safety, regulatory compliance, and organizational standards.
* Develop and modify procedures to support manufacturing processes.
* Participate in process, equipment, and facility validation projects.
* Review and approve process-related commissioning, qualification, and validation protocols.
* Execute protocols to meet project schedules.
* Lead Process FMEAs for Visual Inspection as required.
* Establish and optimize technician certification processes for visual inspection.
* Maintain the defect library and execute defect trending processes.
* Ensure site procedures align with global and regulatory standards.
* Contribute to SOP development for Visual Inspection.
* Lead manufacturing and validation activities during projects.
* Coordinate with stakeholders on particle/defect evaluation.
* Support technical transfers for new product introductions.
* Investigate process exceptions and malfunctions.
* Collaborate with engineering and quality personnel.
* Support production to meet output and yield targets.
Essential Requirements:
* Degree or Masters in engineering, science, or a technical discipline.
* Minimum three years in technical, operations, or quality roles within pharma or healthcare manufacturing.
* Experience in biotech or pharmaceutical manufacturing environments.
* Experience with biotechnological, parenteral, or related manufacturing processes is preferred.
* Knowledge of clean utilities is desirable.
Cognitive Skills:
* Proven problem-solving skills under pressure.
* Innovative thinking and solution implementation.
* High attention to detail and accuracy.
* Results-driven with a commitment to quality.
* Strong communication and interpersonal skills.
* Support for principles of perfect performance.
Ownership/Accountability:
* Commitment to organizational vision and operational excellence.
* Supportive of a positive development culture and compliance.
* Self-motivated with high autonomy.
* Adherence to all policies ensuring cGMP and regulatory compliance.
Influence/Leadership:
* Support cross-functional teams and projects.
* Provide technical leadership and training.
Decision Making/Impact:
* Operate independently with technical discretion.
* Present technical data for decision-making.
Supervision:
* Self-managed environment, no direct reports.
* External contacts with contractors and engineers.
EHS Responsibilities:
* Follow EHS policies and promote safety culture.
* Report incidents and participate in EHS initiatives.
* Attend EHS training and wear PPE as required.
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