C&Q Specialist

We are seeking a C&Q Specialist with expertise in execute qualification activities around an OEM-driven retrofit to an existing GMP manufacturing isolator.

Responsibilities:

• Prepare and maintain all commissioning documentation.
• Coordinate execution with contractor and vendors.
• Maintain commissioning status reports.
• Coordinate closure of deficiencies.
• Participate in project meetings.
• Support turnover to Operations and Maintenance.
• Maintain commissioning records.
• Provide editable electronic copies of all deliverables.
• Provide final PDF copies of all approved deliverables.

Requirements

• Bachelor Degree in Science or Engineering or related field.
• Background in pharmaceutical products manufacturing environmental specially in sterile packaging area.
• Experience in commissioning and qualification.
• Strong knowledge of cGMPs regulations.
• Startup and operational readiness experience.
• More than 5 years of experience in commissioning related projects.
• Experience in digital validation solutions.
• Good skills writing validation/commissioning, and technical documentation in English and using MS Office applications.
• Bilingual (English & Spanish)