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.
The Supervisor of Validation is responsible for the daily oversight of the Validation team. The Validation Supervisor is responsible for ensuring compliance of all re-qualifications on Equipment, Utilities, Facilities and Computer Systems. The complexity of the work demands a solid technical background across a variety of scientific disciplines and fundamentals on Validation Lifecycle which includes Change Control Management, Risk Assessments, User Requirement Specifications (URS), Factory Acceptance Test (FAT), Site Acceptance Test (SAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ).
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Participate and lead teams to ensure appropriate alignment of resources to technical challenges and routine operational needs
- Maintain good working relationships with internal and external partners/customers
- Responsible to ensure departmental resources are appropriately allocated based on work scope and technical needs
- Track and report status on KPIs relevant to Validation activities/responsibilities and ensure commitment to key stakeholders are met in a timely with the highest quality
- Participate in Project Teams as they relate to specific projects
- Ensure that Validation issues are communicated to internal / external customers in a timely manner
- Manage technical aspects of equipment validation at the site, including Equipment Qualifications and re-qualifications, Computer Validations, Periodic Reviews and Validation Master Plans
- Responsible for review and approval of SOPs, Shutdown Reports, Validation Protocols and Summary Reports
- Other documents that may require periodic review and approval include CAPAs, Change Controls and Maintenance Work Orders
- Responsible for ensuring that validation process is reviewed according to standard procedures and established regulatory principles
- Responsible for the department SOPs as they pertain to writing, revision, implementation and training
- Interfaces with all levels of Emergent employees, clients and representatives of regulatory agencies
- Builds a strong working environment that promotes our core values and progresses our culture in a positive manner (healthy cross-functional teamwork)
- Capable of leading change in a positive manner
- Ability to identify and manage talent through requisite HR systems (hiring, compensation, performance management and development) in ways that provide value to both company and employees
- Manage the IPMP for direct reports and mentor associates to facilitate professional and departmental growth
- Good interpersonal and communication skills (oral and written)
- Requires vaccination against different viruses including Vaccinia virus
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
- A Bachelor's degree with a minimum of 7 years industry experience, preferably in Biotech or Pharma, and a minimum of 5 years in Validation
- Prior Supervisory experience preferred
- Experience overseeing validation programs personnel in a fast-paced environment
- Diverse and demonstrated technical knowledge with strong risk management mindset
- Strong technical and communication skills: oral/written and listening
- Personal Competencies: Self-awareness, Integrity, Team Player, Adaptability
- Computer skills (MS Office, SAAP, VEEVA, statistical software, Visio, MS Project)
PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
- 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 does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
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.