Associate Director of Process Validation

Location
Lexington, Massachusetts (US)
Posted
May 09, 2018
Required Education
Doctorate/PHD/MD
Position Type
Full time

The Associate Director of Process Validation oversees process validation activities required for the validation of a process run in a cGMP manufacturing facility. This individual assures validation activities are performed in conformance with applicable Standard Operating Procedures (SOPs), WAVE standards, industry best practices, and regulatory requirements.  The individual writes and helps executing validation related activities such as VMP, DOE, FMEA, PPQ, and QbD.

Responsibilities:

May include some or all of the following:

  • Manages or oversees validation projects which may involve: defining validation scope, risk assessments, strategy, validation plan, and validation schedule
  • Generates final reports
  • Resolves protocol discrepancies and deviations
  • Generates deviations, CAPAs, root cause analysis, and assists with deviation investigations
  • Participates in the reviews and approvals of internal and external SOPs as they relate to validation
  • Develops or revises validation master plans and reports
  • Responsible for the generation of complex protocols using a risk based approach that meets current regulatory requirements and industry practices
  • Will be part of a larger team, need to work well with other team members internally and externally (CMOs).

Education / Experience:

  • PhD Degree in engineering, science or a related field preferred
  • Minimum of 7 years of process validation experience in a cGMP manufacturing environment (or Master’s Degree and 9 years of experience)

Skills / Pre-requisites:

  • Familiar with data logging systems and statistical analysis
  • Basic knowledge of cGMP quality systems preferred
  • Practical knowledge of cGMP regulations required
  • Must be proficient with MS Office Word, Excel, Visio, and Project
  • Excellent oral and written communication and presentation skills
  • Ability to effectively manage time and prioritize tasks independently
  • Excellent organizational skills
  • Ability to manage both day-to-day operations, as well as, project work in a fast-paced environment
  • Ability to effectively manage several tasks simultaneously
  • Must be self-motivated, able to work independently, and have a proven ability to work in a team environment
  • Must be able to work in a laboratory and cGMP manufacturing environment while wearing appropriate personal protective equipment

Training:

  • Trained in cGMP Quality systems such as Change Control, CAPA, and Deviation preferred
  • Previous training on cGMP regulations required
  • Trained on risk based validation approaches that meet current regulatory requirements, and industry practices preferred