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Validation Specialist
2 months ago
Duties & Responsibilities:
- Ensure all processes and methods critical to product quality are appropriately qualified, validated and documented
- Actively participate during all phases of validation including documents for IQ/OQ
- Review engineering drawings
- Analyze data and provide recommendations for improvements
- Maintain system that tracks validation records
- Write, review and approve validation strategies, protocols and reports
- Review validation packages for completeness and accuracy, sound rationale, compliance with policies and procedures, and accurate data analysis
- Establish priorities and schedule activities to ensure timelines and milestones are met
- Some administrative activities may be required as needed
Qualifications & Requirements:
- Detail oriented
- Proficient in Math
- Basic communications and writing skills in English
- Ability to interact and work with team members
- Ability to communicate knowledge to team
- Must have knowledge of current industry expectations of validation requirements for IQ/OQ/PQ/Cleaning/Equipment validations
- Ability to handle multiple projects and deliver reports in a timely manner
- Ability to determine, present, and defend project requirements and status
- Must have knowledge of all current cGmp requirements
- Ability to communicate written and verbally
Vaco values a diverse workplace and strongly encourages women, people of color, LGBTQ+ individuals, people with disabilities, members of ethnic minorities, foreign-born residents, and veterans to apply.
EEO NoticeVaco is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race (including but not limited to traits historically associated with race such as hair texture and hair style), color, sex (includes pregnancy or related conditions), religion or creed, national origin, citizenship, age, disability, status as a veteran, union membership, ethnicity, gender, gender identity, gender expression, sexual orientation, marital status, political affiliation, or any other protected characteristics as required by federal, state or local law.
Vaco LLC and its parents, affiliates, and subsidiaries are committed to the full inclusion of all qualified individuals. As part of this commitment, Vaco LLC and its parents, affiliates, and subsidiaries will ensure that persons with disabilities are provided reasonable accommodations. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact HR@vaco.com .
Vaco also wants all applicants to know their rights that workplace discrimination is illegal.
By submitting to this position, you agree that you will be giving Vaco the exclusive right to present your as a candidate for the foregoing employment opportunity. You further agree that you have represented information about yourself accurately and have not affirmatively misrepresented your qualifications. You also agree to maintain as confidential, to the fullest extent permitted by law, any information you learn from Vaco about the position and you will limit disclosure of information about the position only to the extent necessary to perform any obligations in furtherance of your application. In exchange, Vaco agrees to exercise reasonable efforts to represent you through all solicitation, job screening and resume dispersal.
Privacy NoticeVaco LLC and its parents, affiliates, and subsidiaries (“we,” “our,” or “Vaco”) respects your privacy and are committed to providing transparent notice of our policies.
- California residents may access Vaco’s HR Notice at Collection for California Applicants and Employees here.
- Virginia residents may access our state specific policies here.
- Residents of all other states may access our policies here.
- Canadian residents may access our policies in English here and in French here.
- Residents of countries governed by GDPR may access our policies here.
Determining compensation for this role (and others) at Vaco depends upon a wide array of factors including but not limited to:
- the individual’s skill sets, experience and training;
- licensure and certification requirements;
- office location and other geographic considerations;
- other business and organizational needs.
With that said, as required by local law, Vaco believes that the following salary range referenced above reasonably estimates the base compensation for an individual hired into this position in geographies that require salary range disclosure. The individual may also be eligible for discretionary bonuses.