Associate Director Validation - Biopharma

Job Description

Where will your strong management and leadership skills have most impact? Right here, when you join us managing the resources of several departments and workgroups and a variety of colleagues. Essentially, you will lead entity programs, develop strategies and implementation plans for a variety of processes and work cross-functionally, developing strategic direction and tactical leverage.

Join a dedicated team with this exciting new opportunity for an Associate Director, Validation at our Frederick, Colorado GMP facility. Work in our multifaceted, fast-paced, API-Biopharma manufacturing environment with the ability to contribute to the growing industry of oligonucleotide (DNA-RNA) based therapeutics.

Area of responsibility:

• Provide leadership in Validation to ensure Nucleic Acid Solutions Division (NASD) sites meet the regulatory expectations for cGMP manufacture of the product and are aligned with industry expectations.
• Set direction and provide leadership in the areas of cleaning validation, equipment qualification, computer systems validation, and all other aspects of the Validation Programs for NASD.
• Set policy and drive results for the cleaning validation program for NASD.
• Manages, approves, and generates validation documentation including protocols, plans, reports, and addenda.
• Management of validation life cycle to ensure ongoing validated state of systems through oversight of the execution of validation studies for cleaning and equipment qualification as required.
• Responsible for the Master Validation Plan (MVP) and all related documentation.
• Managerial responsibilities include the development of reports and team through mentoring and training with the objective to have a cross-functional group that works well in a team environment.
• Scheduling, advising activities, budgeting, and hiring for the department.
• Set strategic and technical goals for the validation team to provide continuous improvement in the areas of cleaning validation, equipment qualification, and computer validation driving policy to align with regulatory and industry expectations.
• Serves as a liaison and cross-functional lead with Quality Assurance to provide an overall compliant facility with the highest level of service.
• Provide direction and set goals to ensure compliance with the Quality Management System for Validation ensuring a state of inspection readiness.
• Serve as the lead for Validation during client audits and regulatory inspections.
• Act as a delegate for AVP of Engineering and Facilities and other Validation Managers in aspects of Validation.

This role reports to the Frederick, CO site. Remote work is not an option.

Qualifications

• Bachelors or Master-s degree or University Degree or equivalent in Engineering or equivalent combination of education and or experience preferred.
• 8+ years of experience in the management of no less than 4 direct reports within a cGMP production facility preferred.
• 10+ years of equivalent experience in validation and or engineering in a pharmaceutical and/or Biologics area required.
• Demonstrated strong management and leadership skills in implementing program/organization strategies.
• Experience with leading and setting policy for cleaning validation; preferably in API and or Biologics.
• Experience with defending a validation program with Boards of Health.
• Independent problem solving and the ability to drive a team to support an ongoing cGMP Operation.
• Experience working with cross-functional groups and leading projects through a matrix of resources to complete.

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Additional Details

This job has a full time weekly schedule. Applications for this job will be accepted until at least March 19, 2025 or until the job is no longer posted.

The full-time equivalent pay range for this position is $150,000.00 - $234,375.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations

Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_posting@agilent.com or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.

Travel Required:
10% of the Time

Shift:
Day

Duration:
No End Date

Job Function:
Manufacturing