Sr. Manager, Validation

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 

The Sr. Manager Validation ensures equipment/systems meet engineering specifications, company quality standards, current industry guidelines and regulatory expectations.  Validation is an integral part of design, procurement, installation, startup, proof of compliance to regulatory agencies (FDA and EU) and ongoing monitoring for continued regulatory compliance.  It is an industry expectation that validation is part of the pharmaceutical manufacturing process from early research and development through commissioning, qualification, commercial manufacturing, and on-going validation maintenance and decommissioning of systems.  Validation employees serve as technical Subject Mater Experts (SMEs) for the Manufacturing Facility, Equipment, Utilities and Process.  The department creates and implements changes in the Facility, Process and Qualification program to enhance compliance, reduce costs, improve customer service, increase quality, and strengthen technical base.

The Sr. Manager Validation is responsible for managing all validation related activities for the Lansing sites.  This includes overseeing all phases of validation projects from project proposal, concept (R&D), design, commissioning, process validation, program maintenance and decommissioning.  Validation is accomplished through a department of technical staff, which includes both Emergent employees, Validation contractors and an average department size of 12 people.  This position manages performance and development of direct reports to ensure achievement of organizational and departmental goals and to create a collaborative environment within the company.  The Sr. Manager Validation is responsible for the long-term strategic development and continued compliance of the department and validation program.

This position manages the Validation department resource, scheduling, and planning to support, Hoshin, Capex, Quality Systems, and internal department projects.  The Lansing location is a Biologics Contract manufacturing facility hosting both Emergent Internal and Client projects.  Operations include manufacturing of multiple Bulk Biological Drug Substance and finishing of Drug Products from CMO Filling operations.  GMP compliance to government regulations for validation are ensured through the Validation Master SOPs, Site Validation Master Plan (SVMP), Standard Operating Procedures (SOP’s), Site and Global Quality SOPs/Policies/Procedures.  Maintaining the validated status of facility, equipment and process with the flexibility to host multiple client processes is the primary responsibility of the Sr. Manager Validation.  

The Sr. Manager Validation supports the unique needs of a 24 hour production facility.  This position is primarily a 1st shift position, but this person must be able to support off shift and weekend efforts as they occasionally arise.

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

Leadership Skills

•    Manages Validation employees (including Managers) and consultants with various experience levels
•    Develops Managers, Individual Contributors, and technical experts
•    Is the primary interface for customers, clients and regulators
•    Leads and works on interdisciplinary teams to complete site initiatives
•    Manage and directs work for assigned projects ensuring activities are on time, within budget, meet GxP and company requirements
•    Develop systems that promote and result in improved efficiency within the department and company
•    Reputation as high performing leader with sustained performance and accomplishment
•    Provide customer focus supporting engineering, research and development, quality, manufacturing sciences and technology, and manufacturing as a Subject Matter Expert and leader of the Validation department
•    Manage creation of, execution and adherence to the Departmental Budget
•    Responsible for resource management and resource modeling for equipment, instrumentation, supplies, and personnel in support of projects and initiatives 
•    Provides routine reports regarding budgetary updates and variances against approved budgets
•    Participates in review of contract negotiations for potential customers (specific to review of sections pertaining to Validation)
•    Define metrics that exhibit productivity and throughput in functional area and maintains metrics
•    Communicates metrics, trends, and data summaries to senior management using a variety of media: intranet, reports, and presentations
•    Conducts personnel interviews, performance reviews, develops and administers development plans, performs follow-up on personnel issues, and provides feedback to group
•    Performs all functions associated with recruitment and hiring process for EBOL Validation positions (full-time, part-time, temp, Limited Term)
•    Performs succession planning

Technical Expertise

•    Develop an efficient and robust strategy for maintaining qualification status of all equipment and critical systems in a Pharmaceutical GMP facility
•    Demonstrated success in technical proficiency, creativity and collaboration with others through independent thought, communication and technical writing  
•    Reviews and approve supporting documentation of the Operations QMS, which require validation awareness, or oversite, ensuring compliance of validation within the Validation QMS
•    Possesses strong knowledge of current validation best practices, including governmental regulations and GxPs
•    Processes strong knowledge of Parenteral and Bio-Process industries and regulations  
•    Plan, Coordinate, and Execute assigned projects by effectively using Project Management methodologies
•    SME oversite of all disciplines within Validation:  Commissioning and Qualification, Sterility Assurance, Cleaning Validation, Computer Systems Validation, Validation Maintenance/Risk Management, and Application of Statistical Technique
•    Represents validation on projects and in addressing issues. Develop and recommend solutions outside general practices with a focus on continuous improvement and compliance
•    Summarize major project validation activities in reports

Problem Solving

•    Initiates changes as required in the Validation programs to enhance compliance, reduce costs, improve customer service, and strengthen technical base
•    Collaborates with various departments to reduce product cost and increase productivity while sustaining or improving the validated systems
•    Provide review for items supporting the Operations Quality Management System with regards to the Validation QMS system
•    Proposes unique solutions to complex problems using technical proficiency, creativity and collaboration with others through independent thought, communication and technical writing
•    Supports and owns process troubleshooting, operations support, root cause analysis, and risk assessment
•    Is an SME for and uses proven monitoring and problem-solving techniques such as SPC and DMAIC
•    Exercising judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
•    Determine methods and procedures on complex assignments and implement them after obtaining necessary stakeholder approvals 
•    Determining methods and procedures on complex assignments and providing technical direction and guidance to engineers within the Validation department

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

•    Education:  BS preferably in Science or Engineering discipline.  Other disciplines and/or equivalent job experience will be considered
•    Experience:  Minimum of 12 years of parenteral/bioprocessing pharmaceutical cGMP Quality experience with increasing responsibilities 
•    Experience:  Subject Matter Expertise for the following Validation disciplines: Commissioning and Qualification, Sterility Assurance, Cleaning Validation, Computer Systems Validation, Validation Maintenance/Risk Management, and Application of Statistical Technique
•    Experience:  Previous experience working with FDA, EU, ICH and participating in regulatory agency inspections
•    Knowledge:  Must have competence of cGMPs, ICH guidance, Eudralex
•    Skills:  Must have SOP, investigation, and project protocol writing skills and demonstrated ability to critically evaluate content of such documents
•    Skills:  Must have personnel management skills
•    Skills:  Must have good written communication skills.  The ability to tailor communications to all levels in department and prepare appropriate updates to senior management and executive management.  Must have effective communication skills for “upward” and “downward” audiences
•    Abilities:  Must be able to prepare reports for internal metrics and technical content; and prepare reports and data summaries for FDA review.  Must determine appropriate content and criticality of information
•    Abilities:  Must have good verbal skills.  The ability to communicate clearly and extemporaneously to a variety of audience types.  Must be able to act as representative for the function and develop others to communicate effectively

Preferred

•    Experience:  Experience with DeltaV and PLC systems preferred
•    Experience:  Highly desirable to have prior experience with developing and maintaining department budgets
•    Experience:  Validation programs for CDMO manufacturing preferred
•    Experience:  5 years of leadership experience with direct reports preferred

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.