Cleanroom Certification Specialist
Cleanroom Certification Specialist
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Salary Not Disclosed
1 Vacancy
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 handson experience in cleanroom certification and testing.
- NSF certification required.
- CETA/ CNBT certification required.
- Indepth 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; Companypaid Life Insurance Short Term Disability and LongTerm 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 parttime 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.
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
