Senior Validation Specialist
3 weeks ago
Position Overview:
The Senior Validation Specialist is responsible for creating comprehensive documentation related to the Commissioning, Qualification, and Validation processes within pharmaceutical environments, utilities, and equipment. This role involves drafting and executing protocols (including field verification) and compiling summary reports at client locations.
Key Qualifications:
Essential Requirements:
Bachelor's degree or equivalent practical experience; 2 years minimum experience in commissioning and/or qualification tasks within a regulated sector. Strong analytical and troubleshooting capabilities are essential, along with a keen attention to detail. Candidates should demonstrate the ability to manage multiple tasks effectively and take initiative to meet established deadlines.
Additional Skills:
Proficiency in Microsoft Word and Excel is required. Familiarity with ISPE Baseline Guide 5 (Second Edition) is advantageous.
Other Considerations:
Exceptional verbal and written communication skills in English are necessary. Willingness to travel domestically and internationally as needed. Ability to work (paid) overtime and eligibility to work in the US without sponsorship now or in the future.
About CAI CAI is a fully employee-owned organization founded in 1996, now boasting over 800 professionals globally. We specialize in commissioning, qualification, validation, start-up, project management, and various consulting services aimed at ensuring operational readiness for FDA-regulated and other critical industries. Commitment to Excellence Our philosophy is straightforward; we prioritize our clients' needs, persist until we achieve the desired outcome, and are dedicated to doing whatever is necessary to succeed.As proud owners of CAI, we uphold our Foundational Principles in both our professional and personal lives:
We act with integrity. We support one another. We contribute to society. We invest in our future. With employee ownership, individual success translates to collective success; we strive to achieve team objectives. We prioritize Team Before Self, show Respect for Others, and embody a Can-Do Attitude (our core values). This commitment has fueled our remarkable growth.
Employee Benefits Our full-time roles come with competitive compensation and a benefits package that includes: up to 15% retirement contribution, 24 days of paid time off, and 5 sick days annually, affordable health insurance for employees, financial assistance for both internal and external professional development, and 70% long-term disability coverage provided by the company.
#LI-MV1 We are an equal opportunity employer, proud to hire veterans and promote diversity and inclusion within our workforce.
Diversity is a vital asset for our global organization.We pledge that CAI will operate fairly and equitably for all – our employees, our clients, and the wider community.
This job description is not exhaustive, and you may be assigned additional responsibilities as needed.CAI will also consider qualified applicants with criminal histories in accordance with the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).
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