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Pharmaceutical Systems Validation Expert
2 weeks ago
We are seeking a highly skilled System Validation Specialist with expertise in pharmaceutical engineering.
The ideal candidate will possess strong technical knowledge and experience in commissioning, qualification and start-up of various equipment and facilities.
Responsibilities include providing technical guidance, leading the development of key qualification deliverables, preparing protocols, executing protocols, summarizing data and resolving deviations.
- Provide technical leadership to ensure projects are well defined and action plans are applicable and relevant.
- Develop and execute validation projects in compliance with industry standards and regulations.
- Prepare and review technical documents, including protocols, reports and procedures.
- Collaborate with cross-functional teams to drive project progress and facilitate decisions.
- Engage with other departments as required for design reviews and decisions.
- Travel may be occasionally required for meetings with clients or vendors.
- 5+ years of experience in commissioning, qualification or validation of systems within the pharmaceutical/biotech industry.
- Excellent written and spoken English skills, including preparation of technical documents.
- Knowledge of cGMP operations, including SOPs, change controls and validation.
- Experience with GAMP and Data Integrity requirements.
- Previous pharmaceutical/biotech experience is mandatory for this role.
- Engineering or science degree, preferably in automation, instrumentation, mechanical, electrical, electromechanical, chemical or biochemical discipline.
- Ability to lift 50 lbs and travel on occasion.
- Strong multi-tasking and leadership skills.