What are the responsibilities and job description for the EPM Scientific Lead position at EPM Scientific?
Job Description:
EPM Scientific seeks a highly skilled Validation and Testing Manager to oversee client projects and drive quality assurance.
Responsibilities:
- Manage client projects, ensuring compliance with regulatory requirements and company standards.
- Lead Commissioning & Validation activities, including URS (GMP equipment) management.
- Author and execute FAT, SAT, IOQ, and CSV protocols, applying technical knowledge.
- Maintain accurate records of qualification, validation, and change control activities.
- Collaborate with OEMs and installation vendors to implement projects successfully.
- Develop and review testing documentation, using Word skills effectively.
Qualifications:
- At least 10 years of experience in CQV/CSV, specifically in GMP regulated environments.
- Demonstrated expertise in FAT, SAT, IOQ, and CSV protocol authoring and execution.
- Strong organizational and communication skills, with the ability to work independently and as part of a team.
- Completion of GMP and Good Documentation Practice training.
- Intermediate Word skills for large technical document authoring and editing.
