Process Engineer II

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

✔ 10 Days of Paid Time Off (PTO)

✔ 10 Paid Holidays Annually

The pay range for this position is $95,000 - $105,000 annually. Actual compensation will be based on factors such as location, skills, education, experience, and other relevant qualifications.

Position Overview

This position reports to the Director of Technical Operations and will be responsible for providing expertise and guidance in the field of reagent formulation, filling and finishing activities for the Molecular Diagnostics & Life Sciences manufacturing segment of Argonaut Manufacturing Services. This individual will be hands-on and be directly involved with floor technicians to ensure proper techniques and guidelines are being followed.

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.

Duties and Responsibilities

• Develop and validate methods associated with QC and Manufacturing processes

• Design, specify and validate equipment and processes

• Design and execute experiments to support process changes

• Facilitate transition of new methodologies into manufacturing laboratory

• Troubleshoot existing processes and provide guidance on potential enhancements

• Perform IQ, OQ, and PQ for laboratory instruments

• Respond to process and instrument failures to minimize downtime

• Improve formulation processes and procedures

• Review and support the transfer of client process steps for formulation/filling and improve, when possible

• Responsible for development and implementation of production and analytical "In-process" controls for commercial manufacturing

• Responsible for leading and executing transfer of NPIs from development to manufacturing shopfloor

• Responsible for independently designing and executing experimental protocols, interpreting data from different sources/format and preparing scientific/operations development reports

• Effective communication with all levels of organizational structure, through multiple departments

• Responsible for leading quality investigations like deviations, CAPAs, NCMRs, OOS, OOT issues

• Take initiative to develop and implement new processes to collect data around and analyze the health of production areas

• Create and format technical documents like SOPs, master batch record and work instructions

• Assist in defining technical requirements for new products

• Responsible for identifying and on-boarding laboratory/floor equipment

• Characterize and develop key metrics to drive efficiency and robustness improvements in product development

• Collaborate with Development, Equipment engineering, Quality, Manufacturing, supply chain, and other departments as needed to address issues with and set appropriate specifications for manufactured products

Qualifications and Requirements

• Bachelor's degree in Biology, Engineering, or Computer Science or related field and 4 or more years of experience in industrial setting

• Knowledge of ISO 13485 Quality Management System and GMP

• Must be meticulous and organized with excellent problem solving and analytical skills

• Effective interpersonal and communication skills

• Self-starter who can independently drive projects and day-to-day work tasks to completion while staying on schedule

• Must work cross functionally with team

• An understanding of LEAN practices and the use of continuous improvement tools like Kaizen, 5 why's, fishbone diagrams, DMAIC, poka yoke, value stream mapping

• Understanding of FMEA and risk management

• Experience in organic chemistry, chromatography (HPLC/UPLC, MPLC), NMR and other analytical techniques used in organic synthesis is preferred

• Experience in large scale organic synthesis, clean room manufacturing is a plus

• Familiarity with nucleoside/nucleotide chemistry, oligo synthesis is preferred

• Familiarity with Statistical Process Control and DOE techniques is preferred

• Experience in manufacturing support/sustaining and transferring products from R&D to production preferred

• Experience in laboratory equipment identification and on-boarding is a plus

• Experience with project management and associated organization tools is a plus

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.

As a condition of employment, employees are required to review and sign certain company agreements and policies, including a confidential information agreement and an arbitration agreement for the resolution of employment-related disputes, in accordance with applicable law.

Background checks are conducted to support workplace productivity, safety, and security by ensuring applicant backgrounds and qualifications are suitable for the position being considered.

It is the policy of Argonaut Manufacturing Services, Inc., as part of its hiring procedures, to conduct background checks on finalist(s) for all positions. These checks will be job-related, consistent with business necessity, and conducted pursuant to all applicable laws, rules, policies, and procedures. Background checks may include, but are not limited to, verification with educational institutions or licensing/credentialing boards; standard criminal checks; employment verification; and other pertinent information and resources.

Employment offers will generally be made after successful completion of applicable background check(s). However, any offers of employment made prior to completion of the background check(s) shall be contingent upon successful completion of the check(s). Finalist(s) may be rejected if they provide inaccurate or untruthful information, do not fully participate in a required background check, or do not sign or complete a required form.