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. In July of 2018, Argonaut acquired LyoGen, a leader in dose specific lyophilization capabilities for the diagnostics markets. Argonaut provides the 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
• 14 Days of Paid Time Off (PTO)
• 10 Paid Holidays Annually

The pay range for this position is $108,000.00 - $116,000.00 annually. Actual compensation will be based on factors such as location, skills, education, experience, and other relevant qualifications.

Position Overview

The primary objective of this role is to perform critical tasks that ensure new and existing facilities, utilities, equipment, and processes are properly validated and maintained in a state of control. This position is responsible for the authorship, execution, review, and approval of validation protocols, reports, studies, and related documentation, as assigned by management.

The role requires close cross-functional collaboration to identify critical process parameters and develop test plans that demonstrate equipment, and processes are suitable for their intended use.

Preferred candidates will have prior experience in aseptic drug product and/or life science manufacturing, with a strong understanding of the principles and practices involved in cGMP manufacturing. The candidate must also be well versed in validation principles for pharmaceutical and life sciences production equipment and utilities. Additionally, proficiency in computerized systems validation (CSV) is highly desirable.

This role is 100% On-Site, Monday - Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Flexible start time between 6:00 am and 9:00 am with a consistent schedule. Exceptions to the schedule must be approved by the manager in advance.

Responsibilities and Duties

• Develop, author, and execute validation protocols (IQ/OQ/PQ), reports, and supporting documentation in compliance with regulatory and internal quality standards.
• Author and review validation protocols and reports, and provide technical input for validation deviations, investigations, and change control assessments.
• Ensure that facilities, utilities, equipment, and processes are qualified and maintained in a validated state.
• Assume responsibility for assigned tasks related to equipment, facility, utility, and process qualifications and validations, ensuring compliance with applicable SOPs, regulatory requirements, and safety standards.
• Experience developing and executing equipment impact assessments and validation protocols and reports for production facilities and equipment in a pharmaceutical cGMP regulated environment.
• Collaborate cross-functionally with other departments and external clients to define critical process parameters and acceptance criteria.
• Coordinate and collaborate with cross-functional teams to align validation and compliance efforts, ensuring all qualification and validation activities meet established requirements.
• Experience and expertise in communication exchanges with internal or external customers.
• Support validation activities necessary to achieve the organization's mission and contribute to the execution of strategic growth initiatives.
• Operate effectively both independently and as part of a collaborative team environment.
• Proven success in a validation role in life science and/or pharmaceutical manufacturing environment.
• High intelligence and problem-solving skills.
• Excellent oral and written communication skills and listening skills.

Requirements and Qualifications

• A bachelor's degree is preferred; and five (5) or more years of progressive, relevant cGMP validation experience is required.
• Time and project management skills with the ability to multi-task are essential.
• High level of personal and professional integrity and trustworthiness with a strong work ethic and the ability to work independently with minimal direction.
• Experience in a growth-oriented, cGMP contract manufacturing organization with a focus on compliant execution of business is preferred.

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.