Validation Engineer II

Base Pay Range

$70,000.00/yr – $/yr

• Small Molecules
• Biologics
• Plasma
• Cell and Gene

• Job : R0166713
• Date posted: 11/12/2025
• Location:
  
  Social Circle, Georgia

This position will provide guidance in validation strategy to the site and global projects. The position will have engineering validation signatory responsibility for approval of cleaning cycle development and cleaning validation protocols and final report documents. This position is responsible for assessing and validating cleaning processes.

Primary tasks include development of protocols, coordination of validation activities, execution, preparing final reports and assembly of final validation packages; generation of project plans. Responsibilities will consist of both initial validation efforts as well as revalidation. Additionally, investigations of manufacturing challenges are conducted and process improvements are evaluated and implemented. Final documents are archived and may be included in or support regulatory submissions, and made available as needed during internal and external regulatory/compliance audits.

This position will provide interpretation of regulatory requirements.

This position will work in close cooperation with the manufacturing business units, Engineering, Regulatory, QC, and Quality Operations on a day-to-day basis.

• Applies thorough understanding of cGXPs, GAMP5 and 21
  
  CFR Part 11 (as applicable), relevant SOP curriculum, routine project procedures, and other training as appropriate.
• Performs a variety of projects/studies in several areas at the same time to support manufacturing and engineering.
• Handles projects that are more complex and broad in scope, which require team leadership and task prioritization. Must demonstrate competent and effective planning, coordination, and organizational skills.
• Review and assess change control requests with potential impact to validated state of validation elements, as applicable.
• Handles routine tasks with attention to detail, timely and accurately.
• Participate and interface with cross-functional project team members (Engineering, Manufacturing, Regulatory Affairs, Quality Operations, Quality Validation, Supply Chain, and other technical disciplines) representing the respective validation elements, as applicable, to determine validation strategy and system validation requirements based on concepts of life cycle: user requirements, functional specifications, design specifications, cycle development and validation. Emphasis is on ensuring accuracy and integrity on validation documentation meets regulatory guidelines and industry standards.
• Write protocols and reports, execute, interpret, and evaluate validation documents in terms of acceptability to industry standards (GMPs, FDA, EU and JP Guidelines), procedures, and regulatory requirements such as but not limited to (21 CFR Parts 210, 211, 600, ISO 14644, EC-Annex1, USP-NF, etc.).
• Guide peers in Validation and Engineering Departments to use sound, statistically based Quality Engineering approaches in project, test plans and in analyses and interpretation of test results.
• Utilize Quality-Engineering tools to problem solve/troubleshoot and assist in risk analysis (e.g., FMEA, Design of Experiments, QbD, SPC).
• Must be able to identify opportunities for optimization processes within the department or the site.
• Identify gaps related to validation requirements and Global Validation procedures. May drive and close compliance gaps as they are identified.
• Perform updates to element validation assessments and validation plans, as required.
• Assist / support, as required, in the investigation and closure of non-conformances/events, corrective actions and preventative actions.
• May participate in the generation and updating of standard operating procedures based on operations and validations to meet divisional and regulatory requirements.
• Participate in internal and/or external assessments and/or audits, as required. Support process with timely closure of observations/audit items.
• Assist with regulatory agency inspections, including interfacing with inspectors and corporate/division/internal auditors.…