About this opportunity
Trinity Consultants Engineering & EHS Workforce Solutions lists this Compliance Specialist opportunity in village of tarrytown, New York. Review the employer’s description below for duties, qualifications and application requirements.
Job description
We are seeking a Compliance Specialist to support critical cleanroom and filtration system compliance activities within a pharmaceutical/drug manufacturing environment. This role serves as the primary compliance liaison overseeing third-party vendors responsible for testing, maintaining, repairing, and certifying HEPA filtration systems in controlled manufacturing spaces. The Compliance Specialist will ensure all activities are performed in accordance with regulatory requirements, internal quality standards, and cleanroom certification protocols.
This position offers a balanced blend of field oversight and documentation management, with approximately 50% of time spent in production and cleanroom environments monitoring vendor activities and 50% dedicated to compliance documentation, reporting, and record management.
Provide compliance oversight of contractors and vendors performing maintenance, testing, repair, replacement, and certification of HEPA filtration systems.
Monitor and verify vendor work activities to ensure adherence to company procedures, GMP requirements, and applicable regulatory standards.
Conduct on-floor compliance inspections and observations within ISO Class 5, 7, and 8 cleanroom environments.
Review and approve maintenance, testing, and certification documentation for completeness and regulatory compliance.
Coordinate and oversee cleanroom certification activities and corrective actions related to filtration system performance.
Document observations, deviations, non-conformances, and corrective actions as required.
Partner with Facilities, Engineering, Quality Assurance, and Manufacturing teams to ensure compliant operation of controlled environments.
Support investigations and resolution of cleanroom and filtration-related compliance issues.
Maintain accurate records and documentation in accordance with company quality systems and regulatory requirements.
Participate in audits, inspections, and compliance assessments as required.
Support facility shutdown activities, including planned maintenance and cleanroom certification efforts.
Qualifications
Required
Bachelors degree in Engineering, Quality, Life Sciences, or related technical field.
4-8 years of experience in compliance, quality, facilities, validation, engineering, or related functions within a regulated manufacturing environment.
Experience working in ISO Class 5, 7, and 8 cleanroom environments.
Strong understanding of HEPA filtration systems, cleanroom airflow, environmental controls, and certification processes.
Experience overseeing contractors and vendors in a manufacturing or regulated environment.
Knowledge of GMP requirements and pharmaceutical manufacturing regulations.
Ability to review technical documentation and ensure compliance with company procedures and regulatory expectations.
Strong organizational, documentation, and communication skills.
Ability to work independently and manage multiple priorities.
Preferred
Experience within pharmaceutical or drug manufacturing facilities.
Familiarity with HVAC systems, environmental monitoring programs, and controlled environments.
Experience supporting facility qualifications, validations, or quality systems.
Prior exposure to regulatory inspections and audit support activities.
Work Schedule
Must be available to support facility shutdowns as required
Planned shutdowns occur approximately twice per year, typically in June and December
Shutdown durations generally range from 3-5 weeks
Salary Range:$80,000 - $110,000 annually
Direct hire employment opportunity
Regular work within controlled manufacturing and cleanroom environments.
Frequent interaction with maintenance contractors, certification vendors, engineering personnel, and quality teams.
Required use of appropriate cleanroom gowning and personal protective equipment (PPE).
Key Success Factors
Strong attention to detail and compliance mindset.
Technical understanding of cleanroom operations and HEPA filtration systems.
Ability to effectively monitor vendor performance and maintain regulatory compliance.
Excellent documentation and record-keeping capabilities.
Collaborative approach with cross-functional teams in a highly regulated environment.
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.