Manufacturing Process Engineer @ Argonaut Manufacturing Services - Carlsbad, CA

Job Overview

a month ago

Manufacturing Process Engineer

Argonaut Manufacturing Services - Carlsbad, CA

This position reports to the Director or Manager 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.
Responsibilities

  • 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
  • Actively work with Manufacturing to solve challenges in the production environment
  • Support agency inspections and client audits relating to Molecular Diagnostics & Life Sciences, ensuring compliance with policies, procedures, and regulatory requirements
  • Review and approve qualification and validation protocols and reports for equipment and processes related to Molecular Diagnostics & Life Sciences products
  • Ensure continuous improvement and effectiveness of the manufacturing processes
  • 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

Specific Skills

  • Ability to train operators on manufacturing processes to improve productivity and reduce run times
  • Ability to multi-task in a fast-paced environment, and transition from one assignment to another with minimal training and direction from supervision
  • Strong computer skills. Familiar with MS Excel, Word, and PowerPoint
  • Ability to draft and/or collaborate on SOP’s, NCR’s, Deviation’s, Work Instructions
  • Knowledge of cGMP, ISO, and FDA Regulations, specifically 21 CFR – Part 820, ISO 13485, and ISO 14971
  • Familiarity with Lean Manufacturing cultures in a volume production facility
  • Proven ability to thrive and enable success in a cross-functional and collaborative environment
  • Excellent communication and interpersonal skills and the ability to facilitate constructive, expedient problem-solving
  • Desire to work with all departments to implement change
  • Ability and willingness to work flexible/extended hours if needed
  • Physical Demands include standing stooping, bending, pushing, kneeling, stretching, extensive walking
  • May require lifting of objects whose weight normally will not exceed 35 pounds

Position Requirements and Experience

  • BS/MS in Chemistry, Chemical Engineering, Biochemical Engineering, or related field preferred, however relevant experience will be considered in lieu of education
  • Successfully served in a similar capacity in a contract manufacturing company for a highly regulated market, preferably the life science/pharmaceutical environment
  • Experience and familiarity in reagent formulation, filling and finishing activities with 2 -4 years of directly related accountability for quality in this form of manufacturing

Corporate Overview

Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA. 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 the quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence.

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 with all employment eligibility verification requirements of the Immigration and Nationality Act and all must have the authorization to work in the US.

Location: 2841 Loker Ave E
Carlsbad,CA 92010, Carlsbad, CA 92010

Job Type: Full-time

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