Overview
We are seeking a detail-oriented and compliant QA/QC BMS Specialist to oversee facility, utilities, and automation projects. You will act as the primary quality gatekeeper, providing oversight during the design, commissioning, qualification, and ongoing operation of BMS and environmental control systems in a GMP biopharmaceutical environment.
Responsibilities
- Quality Planning: Develop, implement, and maintain a project-specific QA/QC plan aligned with customer requirements and regulatory frameworks.
- Quality Oversight: Review and approve Commissioning, Qualification, and Validation (CQV) documentation for BMS, HVAC, and critical utility systems.
- Compliance & Auditing: Conduct floor walk-throughs and routine audits to ensure BMS hardware, software, and alarms continuously comply with cGMP standards, FDA, and EMA guidelines.
- Deviations & CAPA: Critically review and approve deviations, root-cause investigations, and Corrective and Preventive Actions (CAPAs) related to BMS or automation failures.
- Change Control: Manage and approve change controls for system modifications, upgrades, and software or hardware patches.
- SOP Authorship: Author, review, and maintain Standard Operating Procedures (SOPs) pertaining to BMS operations, data integrity, and system maintenance.
- Cross-Functional Collaboration: Partner with Facilities, Engineering, and IT departments to address system anomalies and implement risk mitigation strategies.
Qualifications and Requirements
- Education: Bachelor’s degree in Engineering (Automation, Electrical, Mechanical), Computer Science, Life Sciences, or a related technical discipline.
- Experience: Minimum of 4-6 years of experience in Quality Assurance/Quality Control, specifically focusing on automation compliance, validation (CSV), or facilities within the pharmaceutical/biotech industry.
- Regulatory Knowledge: Deep understanding of cGMP regulations, GAMP 5 guidelines, and FDA/EMA requirements.
- System Familiarity: Proven experience with Quality Management Systems (QMS) such as TrackWise, and deep knowledge of BMS platforms (e.g., Siemens, DeltaV, Rockwell).
- Skills: Exceptional technical writing abilities, critical problem-solving skills, and the capacity to effectively communicate complex technical issues to quality and operational leadership.
- Fully Bilingual: Spanish and English
Pay: From $60,000.00 per year
Benefits:
- Health insurance
- Life insurance
- Paid time off
- Professional development assistance
- Retirement plan
Application Question(s):
- Do you have experience on HVAC systems?
- Do you have experience on Building Management Systems? (BMS)
- Able to works during weekends, Saturday and Sunday?
Language:
Work Location: In person
