Manager, Validation

Job Locations US-MA-Bedford
Posted Date 2 months ago(1/11/2021 2:12 PM)
Job ID
2021-1394
# of Openings
1
Category
Engineering

Overview

 

 

The Manager, Validation shall provide strategic, technical leadership and accountability for validations within the organization including commissioning, qualification, and maintenance of the validated state for all direct impact manufacturing systems used to support the clinical development and commercialization of multiple therapeutic drug delivery platform. The position is responsible for coordination and execution of validation studies for manufacturing process, cleaning process, and GMP equipment including autoclaves, glove box, ovens, packaging equipment, incubators, lyophilizers, clean rooms, cold rooms, and other equipment/systems as assigned.

 

The position is set in a dynamic, fast-paced start-up environment and shall require the individual to work on a broad range of tasks.

 

Responsibilities

 

  • Lead and execute validation activities and validation assignments supporting all technical and manufacturing involving the qualification of new and existing facilities, utilities, equipment and/or processes.
  • Write, execute, and lead facilities and equipment validations, reviewing and analyzing data, adhering to GMP regulations.
  • Lead cross-functional teams to establish site validation master plans, cleaning validation master plans, etc. for complex product/device development projects.
  • Incorporate continuous process improvements and policies including functional and user requirement specifications, validation lifecycle, cleaning validations and computer systems validations.
  • Works with cross functional departments for alignment on validation policies, practices and procedures.
  • Technical lead for equipment or facility validations, participating in regulatory inspections.
  • Write and execute test protocols for trials of new materials, equipment, tooling, etc.
  • Participates in creation and/or review of Standard Operating Procedures (SOPs).
  • Manage and coordinate the activities for validations direct reports including planning, responsibility for group engineers, consultants and meeting deliverables.
  • Maintain up to date knowledge of evolving regulatory requirements regarding validation and act as an information resource for the team and business stakeholders.
  • Provide appropriate coaching, development, and associated performance management to staff.
  • Other duties as assigned.

 

Qualifications

 

  • Minimum of bachelor’s degree in Chemistry, Biology, Pharmaceutics, Biomedical, Chemical Engineering or related discipline. Advanced degree (MS/PhD) desirable, with 8+ years’ experience in validations in the pharmaceutical/medical device industry.
  • Strong knowledge and understanding of current Good Manufacturing Practices (cGMP) and FDA 21 CFR Part 210, 211 regulations and standards
  • Proven ability to solve complex technical challenges using a rational, scientific approach.
  • Understanding of quality systems such as change control and discrepancy investigations.
  • Ability to work with people at all levels
  • Project management experience
  • Must be proficient with Microsoft Office, particularly Word and Excel
  • High degree of initiative and self-motivation.
  • Ability to strategically evaluate, manage and meaningfully advance multiple validation projects to schedule.
  • Strong interpersonal and communication skills.
  • Experience solving ambiguous problems.
  • Experience creating technical, written content.
  • This position requires mobility and some physical ability to set up and work with equipment.

 

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