Senior Engineer, Technical Operations

Thermo Fisher Scientific UK

Not specified; not specified; not specified
Not specified (assumed to be on-site based on the job's nature).
Good manufacturing practices (gmp) adherence
Process validation and qualification activities
Technical writing for protocols and reports
Thermo Fisher Scientific is seeking a Senior Engineer for Technical Operations to contribute to the development and manufacturing of biopharmaceutical products. The role requires technical expertise in GMP-compliant processes, project management, and collaboration with cross-functional teams to ensure high-quality standards and enhance production processes

Job Summary

  • This role involves developing and optimizing formulation processes while ensuring the highest quality standards in biopharmaceutical manufacturing.
  • The successful candidate will act as a technical approver for change controls, validations, and risk assessments while leading significant quality investigations.
  • You will provide technical expertise for day-to-day production activities, supporting health authorities' inspections and ensuring compliance with GMP regulations.

Matching Summary

Match Score: 85

Thermo Fisher Scientific is seeking a Senior Engineer for Technical Operations to contribute to the development and manufacturing of biopharmaceutical products. The role requires technical expertise in GMP-compliant processes, project management, and collaboration with cross-functional teams to ensure high-quality standards and enhance production processes.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • Good Manufacturing Practices (GMP) adherence
  • Process validation and qualification activities
  • Technical writing for protocols and reports
  • Change control ownership and review
  • Continuous Process Verification (CPV) leadership

Nice-to-have

  • Lean Manufacturing and Six Sigma methodologies
  • Mentoring junior engineers and staff
  • Cross-functional collaboration skills
  • Advanced analytical problem-solving abilities
  • Experience with SAP or LIMS software systems

Key Requirements

  • Advanced Degree plus 3 years experience OR Bachelor's plus 5 years
  • Strong understanding of GMP regulations and quality systems
  • Expertise in process validation and risk assessments
  • Proficiency in manufacturing documentation systems
  • Demonstrated leadership and mentoring skills

Work Rights

Not specified

Tailored Resume

Cover Letter