Operational Specialist

Headcount Solutions; Toronto; On-site; CAD 70,000 - 95,000; Full time

Job summary

A leading company in the biotech industry is seeking an Operations Specialist for their facility in Toronto. The role involves supporting production operations in a fast-paced environment, ensuring compliance, and driving process optimizations. Ideal candidates will have a background in relevant sciences and substantial industry experience.

Qualifications

• 4+ years of experience in Biotech Industry (bulk manufacturing).
• Understanding of multi column chromatography concepts.
• Familiarity with contamination control and batch release.

Responsibilities

• Lead team members and support end-to-end production operations.
• Monitor operational performance and implement optimizations.
• Write and approve manufacturing documentation.

Skills

Problem Management

Deviation Management

Change Management

Education

Bachelor’s degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process Engineering

Tools

Emerson DeltaV

SIPAT

Job description

Operations Specialist

Headcount Solutions is resourcing an Operations Specialist for our multinational client's biolgics facility in west Dublin.

Reporting to the Process Operations Lead the Operations Specialist will support end-to end production operations for both Fed Batch and Continuous Manufacturing.

This role will involve supporting manufacturing operations on a Shift Rotation basis

Main Responsibilities:

• Lead/Guide team members within the Production Operations team.
• Coach and develop colleagues within the Production team.
• Support team on shift cycle and act as POC (point of contact) and POE (point of escalation) to ensure effective issue resolution.
• Lead, facilitate and participate in cross-functional teams to collaborate effectively to cover compliance topics.
• Responsible for monitoring operational performance, follow-up on any significant adverse trends for the identification and implementation of operational optimization, and robustness improvement projects.
• A Change and QRA Champion within the organization and site, to bring about new technologies, digitization, and identify opportunities to bring new ways of working.
• Lead process investigations on the production floor in support of deviation resolution.
• Support team on 24/7 shift cycle and act as POC (point of contact) and POE (point of escalation) to ensure issue resolution.
• Participate in safety, process and environmental investigations. Review alert and action limits as needed and implement corrective action as appropriate.
• Write, review, and/or approve manufacturing documentation (SOPs, Manufacturing Records & Logbooks).

Requirements:

• Bachelor’s degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process Engineering.
• 4 years + experience in Biotech Industry (bulk manufacturing of pharmaceutical or biological components).
• Understanding of multi column chromatography concepts.
• Familiarity with contamination control and batch release requirements.
• Experience leading, presenting, or supporting Regulatory Inspections and Site Internal Audits.
• Problem, Deviation, and Change Management experience.
• Commissioning and Qualification experience.
• Understanding of Upstream and Downstream Unit Operations for mAb manufacturing.
• Familiarity with Emerson DeltaV, SIPAT, and the use of Automation in a manufacturing Process.

For further information please contact Mick on 086-0435195 or forward details in confidence to [e-mail]