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Director, Validation

Location: 

Gaithersburg, MD, US, 20879 Canton, MA, US, 02021 San Diego, CA, US, 92121


 

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

JOB SUMMARY 

Develop and implement harmonized validation processes and practices across the company.  Assist in governance of validation processes across the sites.  Develop team / network of Validation SMEs capable of supporting Global Validation initiatives and assisting site’s with complicated validation issues.  Provide strategic leadership to the company’s Engineering, Facilities and Validation organization.

 

ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

 

Implement harmonized validation process and practices across the company
•    Develop validation policies and global SOPs that reflect company and industry best practices
•    Remain current on industry and regulatory trends, incorporating emerging regulations into policies and procedures
•    Partner with site EFV Directors and Validation Managers on the implementation of harmonized practices

Assist in governance of the company’s validation processes and project portfolio
•    Monitor and influence the collective performance of the organization’s Site Validation Teams on-going activities
•    Provide validation support and guidance to major capital projects and corporate initiatives
•    Manage implementation of major validation projects

Develop the company’s validation expertise
•    Identify internal expertise in all aspects of validation (cleaning, CSV, etc) across the company
•    Hire, develop, or contract resources to fill gaps between the organization’s validation needs and capabilities
•    Facilitate development of the organization’s validation capability by coordinating cross site sharing and external learning opportunities

Provide strategic and tactical leadership to the EFV organization
•    With other EFV leaders, jointly own the EFV goals of providing excellent service to the sites while harmonizing and optimizing EFV systems and practices
•    Maintain routine contact with site EFV Directors and site Validation Managers

Routine travel (<25%) to global location required

 

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions. 

 

MINIMUM EDUCATION, EXPERIENCE, SKILLS

•    Minimum of 12 years of experience in a biopharmaceutical environment, 8 years in leadership roles, and 5 years in validation 
•    Excellent verbal and written communication skills
•    Ability to think and act both strategically and tactically
•    Highly effective verbal and written communicator at all levels of the organization
•    Demonstrated ability to effectively prioritize and coordinate activities 
•    Proficiency in Microsoft Office applications
•    BS in Engineering, Science, or Management or equivalent experience
•    Advanced technical or business degrees a plus
 

 

Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.

 

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
 

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce.  Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
 

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .
 

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.


Nearest Major Market: Washington DC