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Lead Validation Specialist
2 months ago
Position Overview:
The Lead Validation Specialist is responsible for creating and managing documentation related to the Commissioning, Qualification, and Validation processes within pharmaceutical environments, utilities, and equipment. This role involves drafting protocols and executing field verification, as well as compiling comprehensive summary reports at client locations. Additional duties include organizing and overseeing project work while guiding small teams in documentation development and execution.
Key Qualifications:
Essential Requirements:
- Bachelor’s degree in a relevant scientific or engineering discipline, or equivalent practical experience
- A minimum of 4-8 years of experience in commissioning and/or qualification activities within a regulated sector
- Strong technical problem-solving abilities and a solid understanding of common project-related technical challenges
- Exceptional attention to detail
- Capacity to manage multiple tasks and proactively complete assigned responsibilities within set deadlines
- Ability to work autonomously while effectively building and maintaining a project team
- Proficiency in Microsoft Word and Excel
- Familiarity with ISPE Baseline Guide 5 (Second Edition) is advantageous
- Experience in planning and directing C&Q activities is a plus
Additional Requirements:
- Excellent verbal and written communication skills in English
- Willingness to travel domestically and potentially internationally as needed
- Availability to work (paid) overtime
- Eligibility to work in the US without sponsorship now or in the future
About CAI:
CAI is a 100% employee-owned organization founded in 1996, currently employing over 800 professionals globally. We specialize in commissioning, qualification, validation, start-up, project management, and other consulting services related to operational readiness for FDA-regulated and other critical industries.
Our Commitment:
At CAI, we prioritize our clients' needs, ensuring that we do not cease efforts until the desired outcomes are achieved. Our foundational principles guide our actions both professionally and personally:
- We act with integrity
- We support one another
- We contribute to society
- We work towards our future
With employee ownership, the success of one contributes to the success of all; we strive to achieve collective goals while upholding our core values of Team Before Self, Respect for Others, and a Can-Do Attitude.
Benefits:
Our full-time roles offer competitive compensation and a comprehensive benefits package, including: up to 15% retirement contribution, 24 days of paid time off, 5 sick days annually, low-cost health insurance for employees, financial support for professional development, and 70% long-term disability coverage paid by the company.
We are an equal opportunity employer, proud to hire veterans and promote diversity and inclusion within our workforce. Diversity is a key strength of our global organization.
CAI is committed to fair and equitable operations for all employees, clients, and the wider community.
This job description is not exhaustive, and additional duties may be assigned as necessary.