Website Goodwin Biotechnology

Scope of Function: Plan and execute validation of GMP systems including utilities, controlled temperature chambers, process and lab equipment and instruments, and utilities systems according to cGMP guidelines.  Work with end users, facilities/calibration group and quality assurance to ensure that the facility and equipment are in compliance with Validation Master Plan and GMP guidelines.  Provide guidance in defining requirement specifications with technical staff and end users.  Represent the validation function in internal and external audits.

Reports to: Associate VP Manufacturing

Specific Duties:

  1. Plan and execution of validation and qualification of GMP equipment and facility.
  2. Review qualification protocols and summary reports for qualification activities executed by outside vendors.
  3. Demonstrate a compliant validation strategy for client projects at various time points from early clinical through process performance qualification and registration batches.
  4. Assess resource requirements for managing workload including internal and external support.
  5. Work closely with all departments including quality assurance to ensure the ongoing operation of a validated environment according to GMP guidelines and other regulatory requirements such as EMA.
  6. Manage the process for the creation of documentation and requirements to include but not limited to the following:
    1. Computer Systems Validation Plans
    2. Equipment Validation Plans
    3. Cleaning Validation Plans
    4. Utility/Facility Validation Plans
    5. Environmental Monitoring Validation Plans
    6. Quality Control Validation Plans
  7. Represent Goodwin as an SME in internal and external audits.
  8. Manage all facets of assigned validation projects while maintaining strong communication with client representative and senior management on project status and assistance needed.

Education and Skills Required:

BS in Engineering or other technical degree, 5-10 years of experience in GMP Pharmaceutical/Biotech environment, mechanical aptitude and good documentation skills.

Interacts with:

Facilities, Manufacturing, Process Development, QC and QA at Goodwin Biotechnology, outside contractors, clients and government agencies.