Argonaut Manufacturing Services Inc.
Sr. Equipment Engineer
Argonaut Manufacturing Services Inc., Carlsbad, California, United States, 92002
Position Overview
The Senior Equipment Engineer is responsible for ensuring the reliable operation, maintenance, and continuous improvement of manufacturing equipment in an FDA-regulated biopharmaceutical production environment. This role requires deep technical expertise in automated equipment systems, a solid understanding of regulatory compliance, and the ability to troubleshoot equipment issues expeditiously in order to minimize down time.
This role is an on-site position Monday - Friday 8 hours/day (excluding lunch break). Overtime, nights, weekends and holidays will be required on an as needed basis. Flexible start time typically between 6:00 am - 8:30 am. Schedule flexes with production schedule
. 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 14 Days of Paid Time Off (PTO) 10 Paid Holidays Annually The pay range for this position is $120,000 - $140,000 annually. Actual compensation will be based on factors such as location, skills, education, experience, and other relevant qualifications. Responsibilities and Duties Provides technical support for cGMP manufacturing equipment including automated filling lines, isolators, environmental monitoring equipment, building management system, etc. during production operations.
Troubleshoots automation system issues and implements corrective actions to minimize downtime.
Programs and configures Allen-Bradley and Siemens PLCs, SCADA systems, and HMI interfaces for manufacturing operations.
Oversees and works closely with equipment service technicians assisting in routine and complex maintenance, upgrades, calibrations, qualifications and repairs.
Leads preventive and predictive maintenance programs for critical manufacturing equipment.
Authors and maintains systems documentation including functional specifications, SOPs, calibration, qualification and validation documentation, change controls, deviations, root cause investigations, CAPAs and other cGMP documentation.
Collaborates with Manufacturing Operations and Quality to develop and execute continuous improvement projects.
Serves as Subject Matter Expert (SME) during regulatory inspections by providing technical expertise and documentation.
Ability to manage competing priorities and maintains tight timelines.
Willingness and ability to work irregular hours, including nights and weekends as needed.
Performs other duties as assigned. Requirements and Qualifications 5 + years of professional level experience working with automated biopharmaceutical manufacturing equipment in a highly regulated production environment.
Bachelor's or Master's degree in Engineering preferred.
Knowledge of sterile manufacturing processes and aseptic techniques.
Working knowledge of applicable global quality standards (ISO 13485; 21 CFR 210, 211, 820, Part 11; EU Annex 1
Experience reading/writing technical documents, SOPs, validation protocols, and reports.
Experience leading investigations into nonconformances and deviations generated by automated manufacturing equipment.
Highly organized and detailed-oriented with superior data analysis and problem-solving skills.
Proficient in Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.
Strong oral and written communication skills.
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. 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, untruthful information, don't fully participate in a required background check, or don't sign or complete a required form.
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. 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 14 Days of Paid Time Off (PTO) 10 Paid Holidays Annually The pay range for this position is $120,000 - $140,000 annually. Actual compensation will be based on factors such as location, skills, education, experience, and other relevant qualifications. Responsibilities and Duties Provides technical support for cGMP manufacturing equipment including automated filling lines, isolators, environmental monitoring equipment, building management system, etc. during production operations.
Troubleshoots automation system issues and implements corrective actions to minimize downtime.
Programs and configures Allen-Bradley and Siemens PLCs, SCADA systems, and HMI interfaces for manufacturing operations.
Oversees and works closely with equipment service technicians assisting in routine and complex maintenance, upgrades, calibrations, qualifications and repairs.
Leads preventive and predictive maintenance programs for critical manufacturing equipment.
Authors and maintains systems documentation including functional specifications, SOPs, calibration, qualification and validation documentation, change controls, deviations, root cause investigations, CAPAs and other cGMP documentation.
Collaborates with Manufacturing Operations and Quality to develop and execute continuous improvement projects.
Serves as Subject Matter Expert (SME) during regulatory inspections by providing technical expertise and documentation.
Ability to manage competing priorities and maintains tight timelines.
Willingness and ability to work irregular hours, including nights and weekends as needed.
Performs other duties as assigned. Requirements and Qualifications 5 + years of professional level experience working with automated biopharmaceutical manufacturing equipment in a highly regulated production environment.
Bachelor's or Master's degree in Engineering preferred.
Knowledge of sterile manufacturing processes and aseptic techniques.
Working knowledge of applicable global quality standards (ISO 13485; 21 CFR 210, 211, 820, Part 11; EU Annex 1
Experience reading/writing technical documents, SOPs, validation protocols, and reports.
Experience leading investigations into nonconformances and deviations generated by automated manufacturing equipment.
Highly organized and detailed-oriented with superior data analysis and problem-solving skills.
Proficient in Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.
Strong oral and written communication skills.
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. 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, untruthful information, don't fully participate in a required background check, or don't sign or complete a required form.
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