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).
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.