Manager, Validation/Engineering

Job Locations US-MA-Framingham
Job ID
2020-1392
# of Openings
1
Category
Engineering
Type
Full Time
Company
LFB USA

Overview

The Manager of Validation and Engineering will oversee and lead the design, development planning and implementation of equipment, utilities and computer systems validation for LFB USA, including requalification of existing systems and processes.  The individual will work with staff and relevant departments to develop facility, equipment, computer system validation policies, protocol plans, protocols and standard operations procedures.  This position will be responsible for meeting the project validation and engineering goals and adherence to requalification schedules. The process engineer IV will report to the Manager of Validation and Engineering. This position will be responsible for meeting project validation and engineering goals, and adherence to the requalification schedules. In addition, this individual will be responsible for monitoring and scheduling outside contractors for the required qualification of equipment.

Responsibilities

Responsibilities include:

  • Implement and maintain the quality system programs that support Validation and Engineering.
  • Generate and maintain Engineering and Validation master plans and all associated governing documents.
  • Develop a positive work environment and promote a team approach with a proper department implemented.
  • Develop engineering and validation requirements for the equipment, facilities, utilities and BXP computer systems at LFB USA.
  • Represent Validation and Engineering as a member of the Change Review Board supporting the change control process for new projects.
  • Directs the completion of validation documentation before changes planned are implemented.
  • Manage all utilities systems in accordance with the manufacturer’s specifications, EHS and cGMP requirements.
  • Provide technical assistance to the facilities maintenance technicians as necessary.
  • Will work with LFB USA Quality to ensure all appropriate documentation, standards and practices are developed and in place for all existing and new systems and processes.
  • Review and approve Standard Operating Procedures, specifications, regulatory filings, or other controlled documents as needed to ensure all regulatory and quality requirements are met and maintained.
  • Ensure all cGMP guidance targets and standards are achieved as appropriate.
  • Oversee the execution of the validation plans using internal and external resources.
  • Collaborate with Tech Ops, Quality Control, IT, Supply Chain, GMP Systems and Manufacturing departments for validation planning and communicate the validation standards and requirements.
  • Serves as Subject Matter Expert (SME) and point of contact for staff and Regulatory inspections, providing information and guidance on regulations and procedures related to process equipment and computer system validation.
  • Provides coaching, mentoring and performance feedback to employees. Ensures team has appropriate contingency plans to mitigate impact of the loss of any resource internal or external.
  • Regularly interacts with senior management. Requires the ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship.

Qualifications

Education:     BS and/or MS degree in Chemical or Process Engineering or Biological or Pharmaceutical Science or other related science degree. 

Experience:   MS degree with min 6 years’ experience; or BS degree with min 8 years’ experience in the field of pharmaceutical validation and engineering.  Minimum 3 years of management experience. 

 

  • Good communication skills and experience in a multidisciplinary FDA/GMP environment are required.
  • Proven ability to lead and influence, build consensus, make clear recommendations to ensure key decisions can be made in time.
  • Highly structured and organized with attention to detail and good presentation skills
  • Hands-on experience and knowledge in running, developing and troubleshooting protein purification, clarification, UF/DF, TFF, and filtration processes and utilities (HVAC and water) in large scale facility.
  • Understanding of compliance and cGMP considerations.
  • Demonstrated commitment to continuous improvement – at the individual, department and organizational levels.
  • Demonstrated strong technical writing and presentation skills.
  • Experience in the scale up and operation of large scale biotechnology processes.
  • Hands-on experience with large scale biotechnology unit operations.
  • Experience in working with cross functional teams in high paced environment.
  • Self-organized, self-directing, highly motivated with critical thinking and analysis skills.

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