Visual Inspection Engineer

2 weeks ago

Sligo, Sligo, Ireland Orion Group Full time

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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