C&Q Lead

Flexible & Integrated Technical Services, LLC • Gurabo, PR

18h

About The Position

For Validation and Commissioning & Qualification support in the Engineering area.

Requirements

• Bachelor’s Degree in Life Science or Engineering
• Previous years of exposure in Validation Life Cycle within the Pharmaceutical Industry.
• Bilingual (Spanish & English)
• Good skills in writing general documentation in English and using MS Office applications.
• Experience in Process Commissioning and Qualification.
• Experience in Validation coordination activities.
• Experience in Change Control Development.
• Experience with cGMPs and Data Integrity regulations and guidelines.

Nice To Haves

• Being self-motivated means that you are curious, anxious to explore all possibilities without anyone telling you to (while also following instructions, of course).
• Being creative, with such an eye for detail that nothing gets past you.
• Commitment to serving customers with high-quality research and products.
• Embracing a diverse work culture.
• Commitment to the environment.

Responsibilities

• Development of an overall CQ plan in conjunction with the Client project scheduler.
• Meeting and delivering key project milestones.
• Lead various weekly multidisciplinary CQV, Eng, CM and USER coordination meetings.
• Org chart maintenance and resourcing.
• HSE and Safe Start-Up including LOTO.
• CQV Doc Preparation.
• CQV Execution Readiness.
• CQV Execution.
• P+ID Walk down and Punch item Categorization.
• Deviation Management & Change Control (Process and Automation).
• Punch List Management.
• Vendor Management.
• Developing and Reviewing CQ test plans and specifications prior to their approvals.
• Development and maintenance of training material, matrix and files for all those involved in CQV activities (Integrator, CSV provider, Vendors, Client USERs).
• Management and Filing of CQV related documentation.
• Management: Compliance with a schedule at a system and area level with the planned resource levels.

Benefits

• Excellent, unmatched, never-before-seen customer service of our team
• Flexible
• Family-oriented
• Focused on our resources' well-being

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level