Manager, Validation

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.

Position and Scope

The purpose of this position is to provide leadership to the validation team, and to develop and manage all aspects of the validation program that oversees equipment, facilities, utilities,  qualifications, process and computer validation. This will include supervision of department  personnel as well as hands-on execution of qualification and validation protocols and equipment calibrations. The position is responsible for ensuring that the validation activities are performed within an appropriate level of cGMP compliance. Previous experience with aseptic filling operations and controls and drug product process validation is highly desired.

General Responsibilities

  • Directs the development and implementation of activities in the validation group to meet production goals, quality, and cost objectives.
  • Develops and executes Validation Project Plans (VPP) as necessary
  • Performs Validation Master Plan (VMP) updates.
  • Serves as Subject Matter Expert for internal or external customers.
  • Participates in inspection readiness activities and is significantly involved in inspections by regulatory agencies.
  • Oversees calibration program and manages third party vendors as required.
  • Coaches/mentors staff as a means to ensure performance and professional development.

Specific Responsibilities

  • Lead and assist in performing all tasks necessary to achieve the organization’s mission and help execute growth plans.
  • Assume responsibility for equipment/facility/utility and process qualifications and validations, calibration program, staffing, training and troubleshooting to ensure compliance with applicable SOPs, regulations and safety guidelines.
  • Interact and coordinate with compliance efforts across departments to provide a high degree of assurance that all qualification/validation activities are completed to requirements.
  • Write protocols and reports, and provide technical input to validation deviations and assessments for change requests.
  • Identifies requirements to ensure the validated state is maintained. Maintain accurate tracking of validation studies, equipment and facility status.
  • Determine calibration needs of equipment and establish calibration procedures, tolerances, and schedules based on criticality of application and following good calibration/metrology-based evaluations.

Position Requirements and Experience

  • Experience developing and executing equipment impact assessments and validation test  protocols for production facilities and equipment in a pharmaceutical cGMP regulated environment.
  • Proven credibility as a leader in the life science/pharmaceutical manufacturing environment.
  • Proven track record of exceptional performance in these FDA regulated environments with audit experience from the FDA, other regulatory agencies and clients.
  • Experience and expertise in communication exchanges with clients during tours, meetings and audits.
  • A proven capability to generate shareholder value.
  • Negotiation skills to maximize value in client/regulatory body discussions.
  • A “hands-on” management style with the interpersonal skills required to build a successful team and the desire to motivate, inspire and develop management team members.
  • High intelligence and problem-solving skills.
  • Excellent oral and written communication skills and listening skills

Qualifications

  • A Bachelor’s degree is preferred; and five (5) or more years of progressive, relevant, experience is required. Two or more years of managerial experience also required.
  • Time and project management skills with the ability to multi-task are essential.
  • Must be able to effectively build and lead teams.
  • 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 with all employment eligibility verification requirements of the Immigration and Nationality Act and all must have the authorization to work in the US.

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