Visual Inspection Engineer

4 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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