Great opportunity to be part of a dedicated team serving the rapidly expanding gene therapy market. Vector BioMed aims to become a leading supplier of high-quality Lentiviral vectors for research and clinical use. You will leverage your expertise in Facility and cleanroom operations to ensure maximum up-time and compliant manufacture of viral vectors intended for human clinical use. This position requires a broad understanding of the equipment, utilities and quality systems needed to maintain cGMP compliant operations. Job title and level commensurate with experience and qualifications.
Ideal Candidate: Candidate will oversee day to day operations of approximately 25,000 sq ft of combined office, laboratory and GMP cleanroom space. Emphasis on maintaining all systems required to ensure compliance and operation of GMP manufacturing operations. Coordinate with Landlord for general facilities maintenance and upkeep. Manage in-house and contract activities to achieve goals.
Key Responsibilities:
- Manage all aspects of equipment and systems lifecycle
- Design review and criticality assessment
- Equipment installation and Operation Qualification (IOQ)
- Preventive Maintenance & Calibrations (metrology program)
- Create and maintain equipment master file
- Ensure documentation detailing service, maintenance, etc.
- Ensure operation and maintenance of HVAC system supporting cGMP cleanrooms
- Requires good understanding of mechanical and control systems for cleanroom HVAC operation in order to manage contractors for support
- Work effectively with all stakeholders to assess and prioritize needs and coordinate internal and contract activities to ensure completion of work.
- Understand and apply GMP principles and regulatory guidance that governs best practices for Facilities, Equipment and Utilities operations.
Basic Qualifications:
- Education: Bachelor’s degree in relevant discipline preferred but professional experience in appropriate role may substitute.
- Experience: Minimum of 10 years demonstrated leadership and accomplishment in a Facility and Engineering role within the Biotech/Pharma sector requiring cGMP compliance.
- Skills: Strong understanding of cGMP’s, regulatory requirements, and quality systems. Excellent troubleshooting, problem-solving skills and attention to detail. Proven ability to work effectively in a team environment and mentor junior staff. Strong written and verbal communication skills. Proficiency in Microsoft 365 (Word, Excel, PowerPoint, Teams, SharePoint, OneDrive).
Preferred Qualifications:
- Thorough understanding of Equipment lifecycle
- Working knowledge of typical bioprocess equipment and systems
- Familiar with typical QC analytical equipment (PM & cal requirements)
- Knowledgeable regarding cleanroom air classifications and QC environmental monitoring program
- Proficient with Building monitoring systems operations and alarm response
- Proficient with electronic equipment management systems
- Thorough understanding of quality documentation requirements
- Good familiarity with computerized systems, data networks, data integrity
Physical Requirements:
- Ability to move 50 lbs.
- Ability to climb ladders and stairs
- Ability to use basic tools with proficiency.
What we Offer:
- Competitive salary commensurate with experience
- Benefits package including health insurance, paid time off, 401k retirement plan, short and long term disability and life insurance.
- A bright, collegial, highly motivated team working at the intersection of the most exciting area of science and technology.
- Exceptional opportunities for learning and growth.