Validation Engineer

sgs-job-5803

Engineering
 California
cGMP Regulations
Equipment Qualification
Validation
QC Laboratory
Qualification Protocols

Contract - 12 Months

Location : Vacaville, CA 95688. Support and execute QC laboratory equipment qualification activities under direct supervision while maintaining compliance with current cGMP regulations, quality policies, standards, and established validation procedures. Coordinate qualification requirements with laboratory personnel, vendors, and support teams; author, review, and execute equipment qualification protocols; identify quality and compliance gaps; and support continuous improvement initiatives within QC laboratory operations.

Job Responsibilities:

  • Perform qualification of QC laboratory equipment in accordance with established equipment qualification policies, plans, and procedures.
  • Coordinate with laboratory personnel to define equipment qualification requirements and acceptance criteria.
  • Author, review, and execute equipment qualification protocols and related documentation.
  • Coordinate equipment qualification activities with equipment vendors and internal support organizations.
  • Ensure qualification activities are performed in compliance with current cGMP regulations and applicable quality standards.
  • Review qualification documentation for accuracy, completeness, and compliance.
  • Identify business, quality, operational, and compliance gaps associated with laboratory equipment and qualification activities.
  • Support resolution of qualification-related issues and coordinate appropriate corrective actions.
  • Maintain accurate and timely validation and qualification records.
  • Sign and approve documentation for activities within authorized responsibilities and applicable company procedures.
  • Work closely with QC laboratory personnel and cross-functional stakeholders to ensure equipment is qualified and ready for intended use.
  • Support continuous improvement initiatives that enhance laboratory compliance, operational efficiency, and cost effectiveness.
  • Assist with scheduling and prioritizing qualification activities to meet business objectives.
  • Communicate qualification status, issues, risks, and required actions to appropriate stakeholders.
  • Provide technical and operational support to QC laboratory activities as assigned.
  • Perform additional validation, qualification, and laboratory support duties as requested by management.

Skills:

  • cGMP Regulations
  • Equipment Qualification
  • Equipment Validation
  • QC Laboratory Validation
  • Validation Protocols
  • Qualification Protocol Authoring
  • Protocol Execution
  • Validation Documentation
  • Pharmaceutical / Biopharmaceutical Manufacturing
  • Quality Compliance
  • GMP Documentation
  • Quality Systems
  • Compliance Gap Identification
  • Continuous Improvement
  • Laboratory Equipment
  • Vendor Coordination
  • Cross-Functional Collaboration
  • Technical Documentation
  • Problem Solving
  • Project Coordination
  • Scheduling and Prioritization
  • Verbal and Written Communication

Education/Experience:

  • Bachelor's degree (BS/BA), preferably in a relevant scientific discipline.
  • Experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience.
  • Knowledge of current cGMP regulations or equivalent applicable regulations.
  • Minimum 2 years of experience in validation or equipment qualification is desired.
  • Experience supporting QC laboratory equipment qualification activities preferred.
  • Ability to author, review, execute, and maintain equipment qualification documentation.
  • Strong understanding of quality and compliance requirements in a regulated laboratory environment.
  • Ability to make sound decisions regarding scheduling, priorities, and qualification activities.
  • Flexible approach to problem-solving and ability to provide direction when required.
  • Strong verbal and written communication skills with the ability to effectively influence stakeholders at different organizational levels.
  • Ability to build trust-based and effective working relationships with laboratory personnel, vendors, and cross-functional teams.
  • Strategic thinking with the ability to translate objectives into actionable plans.
  • Strong ownership, accountability, and results-oriented approach.

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