Senior Validation Lead

6 days ago


Lenoir, North Carolina, United States Exela Pharma Sciences Full time

Job Title: Senior Validation Lead

About Exela Pharma Sciences:

We are a leading provider of specialty pharmaceutical products and services. Our mission is to improve patient outcomes by providing innovative solutions in the biotech and pharmaceutical industries.

About the Role:

We are seeking an experienced Senior Validation Lead to join our team. This role will oversee the validation program for production equipment and processes used to support manufacturing of aseptic and terminally sterilized products.

Key Responsibilities:

  • Plan, perform, and coordinate validation projects to ensure timely completion.
  • Responsible for drafting and providing technical guidance for the validation program, policies, and SOPs.
  • Support Engineering and Manufacturing in the development of critical process parameters and provide technical leadership for deviation investigations.
  • Analyze data to provide recommendations for improvements in the manufacturing process and equipment.
  • Assess new and existing processes (including Equipment IOPQ, Process, etc.) against cGMP and requirements for validation.
  • Develop and implement strategies for equipment IQ/OQ/PQ, process validation, computer system validation, and calibration.
  • Perform functional and process risk assessments in conjunction with Quality and Manufacturing subject matter experts.
  • Oversee development and execution of validation protocols and review objective evidence for inclusion in validation reports.
  • Assist with the technical assessment and resolution of deviances and variances that occur during production or validation.
  • Work with Quality, Manufacturing, Regulatory, and subject matter experts to prepare for FDA and other agency audits.
  • Ensure site/system validation program meets FDA, ISO, and EU requirements.
  • Collaborate with peers and stakeholders to identify opportunities for process improvement.
  • Facilitate communication and implementation of consistent processes across various product teams and global manufacturing sites.
  • Provide updates to Senior Management on site validation status activities.
  • Provide validation training to staff on validation protocols and standard operating procedures.
  • Support investigations and implementation of CAPAs, as needed.

Requirements:

  • Bachelor's, Master's, or Ph.D. in Biochemistry, Biology, or related science field.
  • Demonstrated knowledge and application of FDA cGMP/GCP regulations, ANSI/ISO/IEC/ASQC standards, and 21 CFR Part 11 in a manufacturing setting.
  • Demonstrated application of FMEA, Risk Analysis, Validation principles, guidelines, and industry best practice.
  • Demonstrated history of team management and effecting cross-functional change with strong analytical problem-solving and interpersonal skills.
  • Excellent verbal and written communication/documentation skills with a demonstrated ability to clearly present technical topics to a non-technical audience.
  • At least 8 years' experience in the biotech/pharmaceutical industry in validation, quality management, process controls, and continuous improvement in an FDA-regulated environment.
  • A minimum of 4 years' experience with aseptic and terminally sterilized products.

Salary: $120,000 - $150,000 per year, depending on experience.



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