C&Q Sr. Consultant

Flexible & Integrated Technical Services, LLC • Wilson, NC

2d

About The Position

The C&Q Sr. Consultant provides Validation and Commissioning & Qualification (CQ) support in the Engineering area. The role includes planning and coordinating CQ activities, meeting project milestones, preparing and executing CQV documentation and work, and managing compliance with schedules and planned resources. The consultant also supports a diverse, customer-focused work culture and is expected to contribute to high-quality work.

Requirements

• Bachelor’s degree in Life Science or Engineering.
• Previous exposure to the validation life cycle within the pharmaceutical industry.
• Bilingual in Spanish and English.
• Good general documentation-writing skills in English.
• Proficiency using MS Office applications.
• Experience in process commissioning and qualification.
• Experience in validation coordination activities.
• Experience in change control development.
• Knowledge of cGMPs and Data Integrity regulations and guidelines.
• Self-motivated, curious, creative, and attentive to detail.
• Commitment to serving customers with high-quality research and products and embracing a diverse work culture.

Responsibilities

• Develop an overall CQ plan in conjunction with the client project scheduler.
• Meet and deliver key project milestones.
• Lead weekly multidisciplinary CQV, Engineering, CM, and USER coordination meetings.
• Maintain the organization chart and manage resourcing.
• Support HSE and Safe Start-Up activities, including LOTO.
• Prepare CQV documents and ensure execution readiness.
• Execute CQV activities.
• Conduct P&ID walkdowns and categorize punch items.
• Manage deviations and change control for process and automation.
• Manage punch lists and vendors.
• Develop and review CQ test plans and specifications before approval.
• Develop and maintain training materials, matrices, and files for those involved in CQV activities, including integrators, CSV providers, vendors, and client users.
• Manage and file CQV-related documentation.
• Manage compliance with schedules at the system and area levels and with planned resource levels.

Benefits

• The company describes itself as flexible and family-oriented and focused on employee well-being.
• The company offers customer service from its team; other perks are not specified.

What This Job Offers

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