Process Engineer II

Process Engineer IIThis 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 processesDesign, specify and validate equipment and processesDesign and execute experiments to support process changesFacilitate transition of new methodologies into manufacturing laboratoryTroubleshoot existing processes and provide guidance on potential enhancementsPerform IQ, OQ, and PQ for laboratory instrumentsRespond to process and instrument failures to minimize downtimeImprove formulation processes and proceduresReview and support the transfer of client process steps for formulation/filling and improve, when possibleResponsible for development and implementation of production and analytical "In-process" controls for commercial manufacturingResponsible for leading and executing transfer of NPIs from development to manufacturing shopfloorResponsible for independently designing and executing experimental protocols, interpreting data from different sources/format and preparing scientific/operations development reportsEffective communication with all levels of organizational structure, through multiple departmentsResponsible for leading quality investigations like deviations, CAPAs, NCMRs, OOS, OOT issuesTake initiative to develop and implement new processes to collect data around and analyze the health of production areasCreate and format technical documents like SOPs, master batch record and work instructionsAssist in defining technical requirements for new productsResponsible for identifying and on-boarding laboratory/floor equipmentCharacterize and develop key metrics to drive efficiency and robustness improvements in product developmentCollaborate with Development, Equipment engineering, Quality, Manufacturing, supply chain, and other departments as needed to address issues with and set appropriate specifications for manufactured productsQualifications and Requirements:Bachelor's degree in Biology, Engineering, or Computer Science or related field and 4 or more years of experience in industrial settingKnowledge of ISO 13485 Quality Management System and GMPMust be meticulous and organized with excellent problem solving and analytical skillsEffective interpersonal and communication skillsSelf-starter who can independently drive projects and day-to-day work tasks to completion while staying on scheduleMust work cross functionally with teamAn understanding of LEAN practices and the use of continuous improvement tools like Kaizen, 5 why's, fishbone diagrams, DMAIC, poka yoke, value stream mappingUnderstanding of FMEA and risk managementExperience in organic chemistry, chromatography (HPLC/UPLC, MPLC), NMR and other analytical techniques used in organic synthesis is preferredExperience in large scale organic synthesis, clean room manufacturing is a plusFamiliarity with nucleoside/nucleotide chemistry, oligo synthesis is preferredFamiliarity with Statistical Process Control and DOE techniques is preferredExperience in manufacturing support/sustaining and transferring products from R&D to production preferredExperience in laboratory equipment identification and on-boarding is a plusExperience with project management and associated organization tools is a plusArgonaut 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.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.