Validation / Metrology Manager

Organization
Aldevron
Job Location
Fargo
Fargo, ND 58104
Benefits

Health, Vision, Dental, Life, Long and Short Term Disability, 401k w/match, FSA/HSA, PTO

Job Description

Position Summary:

The Validation/Metrology Manager is responsible for supporting and coordinating the work of the Validation / Metrology group to ensure that equipment is qualified, maintained and calibrated properly on schedule, complying to appropriate guidelines / specifications and internal procedures.  Provides leadership in strategy and administration of internal and external programs and processes related to validation activities and metrology for the Aldevron Fargo site. Develops calibration methods and techniques based on principles of measurement science, technical analysis of measurement problems, and accuracy and precision requirements. Develops validation protocols meeting industry standards for equipment, utilities and processes to ensure Aldevron's regulatory compliance in support of client end use.  Additionally, creates and revises Standard Operating Procedures (SOPs).

Essential Duties and Responsibilities:

  • Create and review Standard Operating Procedures, equipment records and qualification records 
  • Work with support departments to obtain user requirements for equipment/utility, assist in the vendor review, instrument demonstrations/evaluations and final vendor selection process
  • Manage the purchase, installation and qualification activities for new and relocated equipment/utilities
  • Monitor the equipment utilization at all sites to move equipment in and out of service to minimize costs and maximize availability
  • Work collaboratively with Manufacturing to develop process validation protocols
  • Implement and manage the Master Equipment List 
  • Responsible for hands-on calibration, supervisory functions, maintenance, troubleshooting, conducting investigations and repair on a variety of equipment/utilities in such a manner to have minimal interruptions within the manufacturing schedule
  • Manages the identification, purchase, scheduling and administration of appropriate service contracts and calibration vendors.  Responsible for determining the need for, identifying, contracting, and managing the efforts of outside consultants and contractors
  • Manage the development and implementation of a validation maintenance program which periodically reviews the status of validated systems
  • Manage the development, implementation, and maintenance of equipment preventative maintenance/calibration program to ensure availability for use
  • Evaluates instrumentation specifications and design applications to identify potential issues that could result in operational vulnerabilities affecting regulatory compliance, excessive costs, reliability, and reduced system availability
  • Manage the development and execution of validation protocols for all facility services, utilities, equipment (including laboratory equipment), and systems including computer systems involved in regulatory processes.  Manage the development and execution of the equipment cleaning validation program.  This includes the development of a cleaning validation master plan for each unique process or product.
  • Support activities for the retirement/re-designation of GMP equipment/utilities
  • Recommends, champions, and administers process and procedure improvements
  • Create and revise preventive maintenance, operational and calibration procedures for equipment/utilities throughout the facility
  • Provides technical expertise and training based on industry best practices to department and supporting departments, as applicable
  • Contributes to the identification and procurement of appropriate test, service, and safety equipment, as well as spare parts and materials for proper maintenance, operation and cleaning for equipment/utilities throughout the facility
  • Define and optimize the overall validation strategies, policies, and programs.  Programs to include change control as developed by the QA department.  Strategic planning to include benchmarking against industry trends as well as continuous improvement in the validation program against current compliance standards and regulations
  • Generate performance metrics associated with departmental work rates
  • Determines project resource requirements for metrology / validation including capacity and capability. Where required assess, appoint, control and direct specific Contractors

Qualifications:

Education:

  • Bachelor's degree in science

Experience:

  • Minimum 7 years' prior biotechnology or pharmaceutical manufacturing or development validation experience in a GMP environment, experience in a supervisory role is preferred
  • Prior experiences managing validation projects and with the regulatory inspection process are necessary

Skills and Knowledge:

  • Working knowledge of cGMP regulations including process validation/product characterization guidelines
  • Must be able to interact well with peers, subordinates, and senior personnel in multidisciplinary teams
  • Experience managing teams and complex projects
  • Experienced in Life Cycle Deliverables
  • Experienced in writing protocols and SOPs, involvement in Change Control and CAPA activities
  • Good "attention to detail" skills
  • Capable of providing direct supervision in a team oriented atmosphere
  • Identifies and resolves problems in a timely manner
  • Gathers and analyses information skillfully Develops alternative solutions
  • Excellent interpersonal, written and verbal communication
  • Strong organizational skills
  • Adapts to changes in the work environment and changing situations
  • Manages competing demands
  • Willingness to perform "hands-on" work in dynamic work setting

Abilities:

  • Ability to be proactive and build strong partnerships
  • Ability to problem solve and troubleshoot systems in a manufacturing environment
  • Ability to coordinate and manage validation activities while involving Metrology, Quality and Equipment/System Owner
  • Ability to manage and prioritize multiple projects with frequent changes and interruptions while maintaining routine on-going activities
  • Strong decision-making ability, capable of setting and balancing priorities

Aldevron is a custom manufacturing organization that provides plasmid, protein and antibody development and production services. Headquartered in Fargo, ND with locations in Madison, WI and Freiburg, Germany we constantly look to innovate and advance life science through collaborative partnerships. Aldevron works with leaders in pharmaceutical, biotech and research institutions around the world to accelerate the development of drug, treatment and preventions for numerous diseases and genetic disorders. Our reputation for innovative solutions for our clients has allowed us to expand our organization and offerings in all service platforms. We are working in a landmark moment in the history of life science.



For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.

https://www.applicantpro.com/j/582476-149639 

How to Apply

For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.

https://www.applicantpro.com/j/582476-149639 

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