Sr. Facilities Technician

Argonaut Manufacturing Services Inc.; Carlsbad (CA); On-site; USD 47,000 - 52,000; Full time

Job summary

Argonaut Manufacturing Services, Inc. is seeking a Facilities support professional to help maintain its cGMP facilities and bring new equipment online.

The role involves creating and revising SOPs, performing preventive maintenance, and supporting facility and equipment validation across complex systems. The position is on-site, Monday through Friday with 8-hour shifts; overtime, weekends, and holidays may be required.

Qualifications

• High School Diploma or equivalent.
• 5 years of progressive experience maintaining facilities and equipment in a cGMP/Drug Product environment.
• 1 year of FMS/BMS experience.
• General plumbing and electrical skills.
• A high degree of mechanical skills are needed for this role.
• Excellent customer service skills.
• Experience following standard operating procedures and recording data extemporaneously in batch documentation/logbooks while following good documentation practices.
• HVAC certified.
• cGMP experience.
• FMS/BMS experience.
• Excellent written and verbal communication.
• Ability to communicate effectively with people in other disciplines.
• Organized, responsible, dependable with an ability to work in a team environment.
• Experienced in the use of Master Control system.
• Working knowledge of 5S and Lean Manufacturing Principles.

Responsibilities

• Support the facilities manager and leadership staff in maintaining cGMP facilities and bringing new equipment online.
• Create and revise SOPs, perform preventive maintenance, and support facility and equipment validation.
• Maintain equipment and utilities including HVAC, clean gas systems, RODI water systems, and related infrastructure.
• Coordinate with other disciplines to ensure quality system compliance and CAPA processes.
• Travel between company locations as needed; a valid driver's license may be required.

Skills

Attention to detail

Communication skills

Documentation

Team oriented

Education

High School Diploma or equivalent

Tools

Master Control system

Job description

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.

Pay Range

The pay range for this position is between $34.00 - $38.00 per hour. Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

Position Overview

The purpose of this position is to support the facilities manager and leadership staff in maintaining the Argonaut cGMP facilities and to bring new equipment online. This includes creating and revising SOPs, performing preventive maintenance activities, and supporting facility and equipment validation. The equipment supported by this role includes cGMP manufacturing equipment and utilities and support plant facilities. Equipment includes but is not limited to, emergency generator, HVAC, clean compressed air, gases, purified water, clean steam generation, temperature-controlled storage units, facility monitoring system, lyophilizers, and autoclaves. Strong time management and organization skills along with interpersonal skills are needed for this exciting new opportunity to help create a highly efficient facility which meets cGMP standards.

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

Responsibilities and Duties

• Autoclaves and steam generation plants

• Preventive maintenance requirements

• HVAC systems

• FMS/BMS installation and/or programing experience

• Dehumidification units

• Clean gas systems

• RODI water systems,

• Handling of hazardous waste pick up coordination

• General plumbing and electrical

• Good documentation practices

• Strong communication skills

• Excellent problem solving / troubleshooting skills for mechanical systems

• Quality system compliance while working in a cGMP production environment

• Attention to detail and disciplined in execution

• Strong initiative and willingness to take ownership and drive projects to completion

• Interest, ability and willingness to work directly on equipment if needed

• Ability to create and revise equipment documentation, PMs and SOPs

• Ability to manage cleanroom equipment, balance airflow and differential pressure

• Advise the manager of factors that may affect quality of the product, initiate problem reports for deviations and non-conforming materials, and provide guidance/options and ideas for corrective actions and preventive actions (CAPA).

• Ability to travel between company locations as needed; a valid driver's license may be required depending on assignment.

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Requirements and Qualifications

• High School Diploma or equivalent

• 5 years of progress experience in both maintaining facilities and equipment in a cGMP/Drug Product environment.

• 1 Year of FMS/BMS experience

• General plumbing and electrical skills

• A high degree of mechanical skills are needed for this role

• Excellent customer service skills

• Intermediate experience following standard operating procedures and recording data extemporaneously in batch documentation/logbooks while following good documentation practices.

• HVAC certified

• cGMP experience

• FMS/BMS experience

• Excellent written and verbal communication

• Ability to communicate effectively with people in other disciplines

• Organized, responsible, dependable with an ability to work in a team environment

• Experience following standard operating procedures and recording data extemporaneously in batch documentation/logbooks while following good documentation practices

• Experienced in the use of Master Control system

• Working knowledge of 5S and Lean Manufacturing Principles

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.