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cGMP Facilities Manager
4 months ago
The Company
Scorpius BioManufacturing is a boutique biologics CDMO providing cGMP manufacturing, bioanalytical, and process development services for protein modalities. Our facility in San Antonio, Texas specializes in working with start-ups, emerging biotechs, and academic researchers. Scorpius was founded by a serial biotech entrepreneur determined to make small-volume programs a big priority. Clients benefit from decades of expertise taking large molecule drugs to market and can rely on Scorpius to offer Quality, Speed, Flexibility, & Responsiveness.
Position Summary
Reporting to the Director, Facilities and Engineering, the cGMP Facilities Manager will provide leadership for the Scorpius Facility Team. This entails independently supporting day-to-day operations including Clean Rooms, Clean Utility Equip. Maintenance, Project Engineering, Planning, Coordinating Team Activities, and Vendor/Supplier Management at Scorpius BioManufacturing.
The ideal candidate must be organized, self-motivated, versatile and thrive in a fast-paced and dynamic biotech environment with a strong desire to make a significant impact.
Key Responsibilities
- Following FDA or appropriate global regulations and guidelines, this individual will maintain the facility at the highest level of regulatory requirements.
- Lead a team of maintenance technicians to ensure that maintenance activities are carried out compliantly, safely and efficiently.
- Maintain operation of the Scorpius Buildings, addressing improvements and repairs as needed.
- partner with EH&S to ensure safety measures are in place and maintained.
- Manage and execute projects designed to address facility needs for both static operations and growth.
- Collaborate with Manufacturing and QA to ensure that all equipment and facilities are properly maintained and available for use.
- Identify areas for improvement and implement changes to increase efficiency and reduce downtime.
- Develop and maintain relationships with service providers to ensure that the plant has access to the latest technologies and maintenance services.
- Work closely with other department managers to ensure that the plant is operating at peak efficiency and that all equipment and facilities are properly maintained.
- Ensure that all maintenance records are properly documented and maintained.
- Manage Work orders and support Quality Assurance group by assisting in preventative maintenance, change control, deviation investigations, CAPA, risk analysis, etc.
- Manage relationships with outside contractors and vendors, and service contracts.
Education & Experience
- Requires 10+ years in cGMP Facilities & Maintenance within a cGMP compliant facility. Emphasis in quality management systems and clean utility facility equipment support.
- A minimum of 5 years of experience in managing Facilities teams in cGMP environments
- Experience working in a cGMP manufacturing environment is essential.
Knowledge & Skills
- Knowledge of FDA regulated cleanroom facility operations.
- Knowledge of clean utilities including but not limited to: RO/DI, WFI Generation & Distribution, Clean Steam Generation, Process Gas Manifolds…
- Outstanding interpersonal skills: ability to build strong relationships with cross-functional team members and lead through influence.
- Must maintain a working knowledge of current global regulatory requirements and guidelines and perform within all Standard Operating Procedures (SOPs) and policies.
- Ability to take responsibility and “get the job done” in a high-energy, high-intensity, results-oriented environment.
- Excellent verbal and written communication skills; strong presentation skills as this role requires the ability to communicate and connect with all levels of the organization.
- Must possess good to excellent writing and PC skills with a knowledge base in Microsoft Word, Excel, Power Point, and Project.
Physical Requirements and Working Environment
- Flexibility is required for working hours. Some weekend work may be needed and earlier or later start/finish times may also be required.
- The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate. This position may involve a combination of office and laboratory environments and automated equipment.
- While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus. The employee must have the manual dexterity and manual ability to effectively use computer terminals.
