Summary of Position:

Lead the Validation Team to provide excellent service to customers and ensure compliance to cGMP FDA/EMEA regulations. Serve as a Validation subject matter expert, track, and report action plan status/ completion as it relates to validation systems improvement efforts. Responsible for managing the development and the execution of qualifications, validations, re-qualifications and re-validations for process and laboratory equipment, computer systems, utilities, facilities, manufacturing, and cleaning processes.

Support ongoing site wide projects by collaborating with experienced members of the Engineering, MS&T, Operations and QA teams to identify roadblocks and additional efficiencies. Additional daily responsibilities include performing and documenting risk assessments of systems and processes, assessing change proposals, drafting/reviewing/approving protocols, and reports, evaluating deviations/change controls and initiating revisions of GMP documentation related to validation.

Essential Functions:

1. Responsible for the day-to-day activities conducted by the Validation department.

   
   

2. Provide leadership on the activities of the internal validation staff as well as external validation contractors.

   
   

3. Lead team member assignments to assure tasks are completed accurately and to schedule.

   
   

4. Establish priorities to ensure that deadlines are met, and budgets are not exceeded.

   
   

5. Oversee the site Validation Master Plan, using input from internal and external resources for continuous improvement.

   
   

6. Create, coordinate, maintain and enforce Validation systems, policies, and procedures.

   
   

7. Participate in audits and inspections conducted by internal and external entities.

   
   

8. Able to correctly assess all change controls with an accurate understanding of the bigger picture implications of changes.

   
   

9. Review and approve all business unit validation testing and documents for completeness and accuracy, sound rationale, compliance with validation policies and procedures, and accurate data.

   
   

10. Ensure all revalidation requirements are met for equipment, process, and cleaning site wide.

    
    

11. Manage the revalidation program.

    
    

12. Team member for new product introductions, regulatory compliance initiatives, implementation of process improvements.

    
    

13. Forecast and manage project work correctly and independently; able to be an independent interface to other portions of the organization as assigned, providing updates as requested and seeking out higher level input when it is necessary; scope of projects managed is large and complex.

    
    

14. Write and review policies or procedures for compliance with regulatory guidance.

    
    

15. Active leader and decision maker, as needed, on internal projects related to formulation, filling, environmental, facility improvements and developing new approach to business.

    
    

16. Work with Regulatory Affairs to prepare Regulatory Submission Documents for project initiatives.

    
    

17. Lead initiatives to streamline processes and workflow by initiating Operational Excellence initiatives.

    
    

18. Interact with management, senior management, and stakeholders to determine project scopes, timelines, and prioritization of global and local projects.

    
    

19. Manage validation activities for large scope capital projects (including Turnaround projects) that encompass multiple protocols and/or a validation plan.

    
    

20. Direct supervision of contractors or other specialists.

    
    

Key Requirements: 

1. Thorough knowledge of validation life cycle, validation protocols (IQ/OQ/PQ) generation and execution of manufacturing and laboratory equipment, clean process utilities, classified facilities, cleaning, and Process Validations.

   
   

2. Thorough knowledge of the of steam sterilization, cleaning and process validation and equipment qualification.

   
   

3. Strong leadership skills, the ability to prioritize, multitask and work efficiently in a dynamic, ever changing manufacturing environment.

   
   

4. Perform administrative duties associated with managing a department and staff. (i.e. establish group goals, and performance reviews).

   
   

5. Strong coaching and mentoring skills and a track record of developing direct reports.

   
   

6. Identify quality issues, and in conjunction with site Quality Manager, recommend and implement corrective and preventative actions.

   
   

7. Good communication with multiple individuals, departments, contractors, auditors and strong organizational skills.

   
   

8. Knowledge of cGMP, cGLP, cGXP, FDA, ICH, EMEA and 21 CFR 11 regulations, guidelines, policies and procedures for parenteral/injectable products.

   
   

9. Proactively manage and maintain regulatory compliance (US/EU/WHO/Brazilian/Korean standards).

   
   

10. Knowledge of agency and vendor audits.

    
    

11. Able to respond/react with appropriate urgency/ professionalism and make decision under pressure.

    
    

12. Support goals and initiatives tied to Guerbet Plan and department goals.

    
    

13. Evaluate current systems and process to determine upgrades, additional technology and improve as needed.

    
    

14. Support document approval for URS, DQ, Protocol {IQ, OQ, PQ, PPQ}, validation batch records, change request, Risk Assessments, Reports, Test plans/ Transfers, laboratory documents/ Testing and SOPs.

    
    

Department Specific/ Non-Essential Functions:

• Enforce EHS procedures and respond to EHS concerns within his/her area of operational responsibility. Perform incident investigations and follow through regarding corrective actions.

  
  

• Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. Report all safety and/or environmental incidents to management immediately.

  
  

• Other duties as assigned with or without accommodation.

  
  

Preferred Skills/ Qualifications: 

• Knowledge and application of Risk Based approaches to Validation.

  
  

• Able to balance, resources, voice of the customer and timelines, while implementing robust and defendable validation strategies. 

  
  

• Ability to work independently in a fast-paced environment and manage multiple project and priorities.

  
  

• Candidate should possess experience in equipment C&Q, cleaning, sterilization, and process validation. 

  
  

• Demonstrated expertise in Six Sigma and Lean projects that utilized the concepts and tools for problem definition, root cause analysis, risk assessment, process development, and statistical analysis. 

  
  

• Strong knowledge of ICH guidelines and QBD principles applicable to a manufacturing environment, with successful application experience. 

  
  

• Industry guideline knowledge of 21 CFR part 11, 21 CFR part 210, 21 CFR part 211, IPSE, PDA, MHRA, PICs, MFDS.   

  
  

• Validation experience, verbal and written communications, ability to manage multiple tasks. 

  
  

• Strong team member with demonstrated ability to work collaboratively with others. 

  
  

• Candidate must possess personal drive and the ability to schedule work assignments so that they are concluded in a timely, complete, and error-free manner with the highest level of accountability. 

  
  

• Proficient and effective communication with both team members and other plant support groups. 

   

  
  

Other Skills: 

• Planning, organization, leadership, teamwork.

  
  

Education and Experience: 

• BS degree in engineering/ life sciences. 

  
  

• 10 years of validation experience in a pharmaceutical environment. 

  
  

• 8 years supervisory experience. 

  
  

• Relevant experience with industry process validation requirements and expectations. 

  
  

• Working knowledge of the science and technology for the major unit operations associated with parenteral/ injectable manufacturing/ packaging operations. 

  
  

• Experience with troubleshooting/ problem-solving and risk assessment/ mitigation.

  
  

Organizational Relationships/ Scope: 

• Reports to Quality Manager.

  
  

• Provide coverage for site Quality Manager in their absence.

  
  

• Frequent communication with Production Coordinators, Q&R Staff and plant Team Leaders.

  
  

• Interact with external regulatory inspectors, vendors and internal R&D and regulatory personnel.

  
  

• Manage site validation activities.

  
  

• Assure validation meets global regulatory requirements.

  
  

• Frequently interact with others, relate sensitive information to diverse groups.

  
  

• Work with diverse groups to obtain consensus on issues.

  
  

Working Conditions: 

• Must be able to perform essential functions in multi-level, light industrial operation.

  
  

• Work is performed in an office and/or a laboratory/manufacturing environment.

  
  

• Must be flexible with schedule to ensure that all essential functions for the department are met on a timely basis.