Cleanroom Certification Specialist at The Vertex Companies LLC in Boston, Massachusetts

Job Description:

Company Description



The Vertex Companies, LLC (VERTEX) is a global $150M professional services firm that offers integrated forensic consulting, expert witness services, construction project advisory, and compliance and regulatory consulting to a myriad of markets and industries. Our brand purpose is to better outcomes for our clients, colleagues, and communities. Join us if you are looking for a career that offers you a chance to love what you do, continuously learn, and take pride in your work.



Job Description



Vertex is seeking an experienced Cleanroom Certification Specialist to join our team. The ideal candidate will have demonstrated expertise in testing and certifying pharmaceutical cleanrooms in accordance with ISO, FDA, and USP standards.



Key Responsibilities:

• Perform cleanroom validation and certification processes, including particle counting, HEPA filter integrity testing, airflow visualization studies, and environmental monitoring.


• Work within pharmaceutical and medical device manufacturing environments to ensure compliance with regulatory standards.


• Utilize and maintain cleanroom testing equipment such as particle counters, photometers, anemometers, and differential pressure gauges.


• Document and report all testing procedures and results in compliance with industry regulations.


• Collaborate with facility managers, quality assurance teams, and regulatory compliance officers to ensure proper cleanroom function and contamination control.


• Develop and maintain technical documentation and certification reports with a high level of accuracy.


• Travel up to 50% is required - locally, regionally, and nationally.


• Available to work nights and weekends when required, on a project basis.

Qualifications

• Minimum 5 years of hands-on experience in cleanroom certification and testing.


• NSF certification required.


• CETA/ CNBT certification required.


• In-depth knowledge of ISO 14644, USP 797/800, and other relevant cleanroom standards.


• Strong proficiency with cleanroom certification equipment and instrumentation.


• Excellent technical writing skills for preparing detailed certification reports.


• Strong communication and collaboration skills to effectively work with multidisciplinary teams.


• Ability to work on ladders for extended periods.

Preferred Experience:

• ASHRAE 110 certification preferred but not required.


• Mechanical and/or biomedical medical equipment experience.


• Electrical troubleshooting Environmental monitoring and sampling experience.


• Knowledge of airflow dynamics and contamination control in critical environments.


• Familiarity with GMP (Good Manufacturing Practices) and cleanroom design principles.

Additional Information



All your information will be kept confidential according to EEO guidelines.


VERTEX offers a solid total compensation package including base salary and discretionary bonus plan. We also offer a robust benefits package including, healthcare (with multiple plan options) and dental; Company-paid Life Insurance, Short Term Disability, and Long-Term Disability. We offer a 401k plan with immediate match and vesting, Flex Spending Account, Employee Assistance Program, and other perks. We provide a generous paid time off plan for eligible employees including 15 days of vacation, 64 hours of sick time, and 9.5 paid holidays (prorated for eligible part-time employees). Our "Lifetime of Learning" program also offers tuition reimbursement and additional support for pursuing advanced education, to help employees grow their skills and careers.


VERTEX is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.


If you require assistance to complete any part of the application process, please contact our Recruiting team at .


NOTICE TO THIRD PARTY AGENCIES:


Please note that VERTEX does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Fee Agreement, VERTEX will not consider or agree to payment of any referral compensation or recruiter fee. In the event a recruiter or agency submits a resume or candidate without a previously signed agreement, VERTEX explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of VERTEX.


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