Validation Engineer

Raleigh, USA

The Validation Engineer will be responsible for ensuring that systems, including equipment, facility, utility, laboratory systems, and computerized systems are installed, operate, and perform as specified. This individual is responsible for writing, executing, and summarizing validation protocols, assisting in the development and maintenance of specification documents (URS/FRS/CS/DS), traceability matrices, and development of validation plans. This position will also assist user groups in troubleshooting and analyzing of systems and lead the resolution of deviations noted during a systems lifecycle.

The Validation Engineer will author new or revise procedures based on established industry best practices and regulations/guidance. This role will also take part in the assessment of new regulations and guidance on the use of systems in a GMP environment and help revise programs to ensure continued compliance.

All activities will be performed in accordance with regulations and expectations, industry best practices, corporate policies, local governing procedures and divisional and site Environmental Health and Safety requirements. This individual will also provide support and some oversight of contract validation resources.

Published on November 19, 2019

RESPONSIBILITIES:

  • Implements and supports validation activities related to site start-up, commissioning, qualification and validation for GMP manufacturing facility, operations, equipment, utilities, computerized systems, etc.
  • Collaborates with project teams to support commissioning efforts and provide technical input as needed.
  • Write, execute, summarize and review qualification / validation protocols and commissioning documentation.
  • Lead the resolution of deviations noted during protocol execution.
  • Evaluates and analyzes validation data for accuracy and sufficiency.
  • Assist user groups in troubleshooting and analyzing systems for cGMP manufacturing and testing.
  • Authors and reviews validation project documentation as appropriate, such as Risk Assessments, Validation Plans, Change Impact Assessments, Design Specifications, User Requirements, Functional Requirements, Risk Assessments, Trace Matrices, IQ/OQ/PQ Protocols and Summary Reports.
  • Adheres to requalification and periodic review schedule for systems per procedure and established plans.
  • Follow departmental and company-wide SOPs and policies, including Site Validation Master Plan.
  • Review or author new validation, commissioning, and risk assessment procedures as required.
  • As needed, manage and serve as the information resource for contractors and vendors hired to support validation activities.
  • Indirect management of small to mid-sized validation project team.
  • Participates actively with MSAT and Validation team to establish the annual goals and desired culture.
  • Gathers on-going industry knowledge and stays abreast of new developments in the industry and in governmental regulations.
  • Other duties as required.

POSITION REQUIREMENTS:

  • Bachelor’s degree, preferably in a technical/science/mathematical field.
  • 3+ years of validation experience in a biotech/pharmaceutical environment. 
  • Direct experience working in cleanrooms and/or sterile facilities is required.
  • Prefer strong knowledge and experience in Process Validation (PPQ and CPV) or laboratory systems. Exposure to other validation areas including Utilities, Computerized Systems, Manufacturing Systems, and/or Process Validation.
  • Knowledgeable in the application and implementation of 21 CFR Part 11 and EudraLex 4 Annex 15 strategies and Data Integrity considerations.
  • Strong written and oral communication skills with ability to interact with various individuals and roles throughout the organization and with external consultants.
  • Technical writing background; able to read/analyze/interpret common scientific/technical documents.
  • Results oriented, self-motivated, self-starter with flexibility to adapt to changing priorities and ability to manage multiple projects/activities simultaneously.
  • Strong working knowledge of good documentation practices and FDA/EU regulatory requirements and guidance documents.
  • Good interpersonal, organizational and trouble shooting skills.
  • Strong ability and willingness to learn and work within a team environment.
  • Highly ethical and transparent, with professional sensitivity and care for confidentiality.
  • Excellent MS Office (Word, Microsoft Excel, and Power Point) required.
  • Ability to lift up to 20 pounds.