Technical Specialist – Pharma Manufacturing & Analytics

Bimeda, Inc.

Cambridge

Hybrid

CAD 60,000 - 70,000

Full time

7 days ago
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Benefits offered by this job

13 paid holidays.
Competitive vacation policy.
Employee Assistance Program.

Job summary

Bimeda seeks a Technical Specialist to join the Cambridge site, responsible for coordinating line transfers, batch scale changes, and NPI transfers within the Technical Operations team. The role emphasizes cGMP compliance, data-driven decision making, and post-launch investigations.

This on-site, full-time position supports cross-site knowledge transfer, brings data analytics to quality improvements, and aligns with Bimeda's expanding manufacturing network.

Qualifications

  • Minimum 5 years of related experience.
  • Sterile manufacturing / fill-finish experience in pharma (sterile injectables preferred).
  • Engineering or Science degree required or preferred.
  • Lean/Six Sigma or similar improvement training is an asset.
  • Experience with electronic quality management systems (eQMS) and data trending is beneficial.

Responsibilities

  • Lead PLCM product investigations end-to-end within required timelines.
  • Coordinate cross-functional teams and manage projects with cost, quality, compliance, safety, and delivery targets.
  • Produce and maintain SOPs, MBRs, deviations, and specifications; drive training as needed.
  • Support environmental, safety, and regulatory requirements; ensure audit readiness and compliance.

Skills

Sterile manufacturing
Project management
Data analysis
Regulatory compliance
English proficiency

Education

Engineering or Science degree

Tools

Microsoft Office
eQMS / MES tools

Job description

Bimeda seeks a Technical Specialist to join the Cambridge site, responsible for coordinating line transfers, batch scale changes, and NPI transfers within the Technical Operations team. The role emphasizes cGMP compliance, data-driven decision making, and post-launch investigations.

This on-site, full-time position supports cross-site knowledge transfer, brings data analytics to quality improvements, and aligns with Bimeda's expanding manufacturing network.

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