Senior Facilities Manager

Corporate Overview

Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA with over 100,000 square feet of manufacturing space across four locations. The company is dedicated to serving highly innovative companies in the biopharmaceutical and molecular diagnostics industries. Argonaut is a full service, cost-effective partner, providing complete solutions in the areas of formulation, filling and final kitting of reagents and consumables. Argonaut provides quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence.

Benefits and Pay Range

At Argonaut Manufacturing Services we value our employees and are proud to offer a comprehensive benefits package designed to support your well-being and financial future. Eligible employees enjoy:

Medical, Dental, and Vision Insurance Company-Paid Life Insurance (1x Annual Salary) Voluntary Life Insurance Options Short-Term and Long-Term Disability Insurance Flexible Spending Account (FSA)Health Savings Account (HSA) 401(k) Retirement Plan with Company Matching 14 Days of Paid Time Off (PTO) 10 Paid Holidays Annually

The pay range for this position is $145,000 - $160,000 annually. Actual compensation will be based on factors such as location, skills, education, experience, and other relevant qualifications.

Position Overview

In this role the Senior Manager will lead the Facilities department to ensure that all GMP manufacturing facilities, utilities, and related equipment are maintained and operated in a state of control, ready for production. The Senior Manager possesses extensive knowledge of the operation and maintenance of biopharmaceutical manufacturing facilities, clean rooms, automated controls systems, boilers, chillers, water purification systems, HVAC, MEP, cold storage units, building management systems, emergency electrical generation systems, and other plant systems and utilities. The Senior Manager will also be involved in the planning and execution of the company's expansion plans including oversight of construction of new facilities and modifications of existing facilities.

This role is an on-site position Monday - Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays will be required as needed. Flexible start time between 7:00 am - 9:00 am with a consistent schedule.

Responsibilities and Duties

• Work closely with Facilities and Manufacturing Operations personnel to maximize manufacturing uptime by maintaining the facilities, utilities and equipment in a state of production readiness.

• Daily operational support and troubleshooting as needed.

• Serve as the Subject Matter Expert (SME) for a variety of facilities, utilities and equipment supporting a GMP biopharmaceutical and med device manufacturing operation.

• Oversee work performed by contractors to ensure compliance with company procedures, plans and regulatory requirements. Ensure project documents are complete, current, and stored appropriately.

• Track and analyze historical data of operations and KPIs. Provide reports and presentations on proposed continuous improvement projects.

• Provide input and oversee the creation of SOPs, Protocols, Deviations, CAPAs and other GMP documentation.

• Provide input on procedures for equipment maintenance and calibration.

• Support of engineering change control for new equipment design and modification.

• Creation of impact assessments for equipment changes.

• Support of internal processes to ensure regulatory compliance is maintained.

• Cross-functional collaboration to complete projects and solve problems.

• Requirement for excellent communication skills and the ability to interact with cross-functional groups at all levels.

• Ability to manage competing priorities and maintain tight timelines.

• Ability to work irregular hours, nights, weekends.

• Perform other duties as assigned.

Requirements and Qualifications

• Work closely with Facilities and Manufacturing Operations personnel to maximize manufacturing uptime by maintaining the facilities, utilities and equipment in a state of production readiness.

• Daily operational support and troubleshooting as needed.

• Serve as the Subject Matter Expert (SME) for a variety of facilities, utilities and equipment supporting a GMP biopharmaceutical and med device manufacturing operation.

• Oversee work performed by contractors to ensure compliance with company procedures, plans and regulatory requirements. Ensure project documents are complete, current, and stored appropriately.

• Track and analyze historical data of operations and KPIs. Provide reports and presentations on proposed continuous improvement projects.

• Provide input and oversee the creation of SOPs, Protocols, Deviations, CAPAs and other GMP documentation.

• Provide input on procedures for equipment maintenance and calibration.

• Support of engineering change control for new equipment design and modification.

• Creation of impact assessments for equipment changes.

• Support of internal processes to ensure regulatory compliance is maintained.

• Cross-functional collaboration to complete projects and solve problems.

• Requirement for excellent communication skills and the ability to interact with cross-functional groups at all levels.

• Ability to manage competing priorities and maintain tight timelines.

• Ability to work irregular hours, nights, weekends.

• Perform other duties as assigned.

Argonaut Manufacturing Services, Inc. is proud to be an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. Argonaut complies will all employment eligibility verification requirements of the Immigration and Nationality Act and all must have the authorization to work in the US.