Qualification & Validation Engineer II - capital projects

Summary:
Commissioning and Qualification (C&Q) contracted services to support capital projects for the Engineering department of a pharmaceutical manufacturing industry in Puerto Rico.

Responsibilities:

• Provide technical leadership for commissioning, qualification, and computer system validation activities, including:
  • Leading and executing end-to-end qualification and lifecycle management of facilities, utilities, manufacturing equipment, process systems, and computerized systems.
  • Planning, coordinating, and delivering qualification and validation project milestones within scope, timeline, and budget constraints.
  • Developing, reviewing, approving, and executing validation lifecycle documentation, including Validation Master Plans, User Requirements Specifications (URS), Functional and Design Specifications, Risk Assessments, Commissioning Plans, IQ/OQ/PQ protocols, and summary reports.
  • Directing protocol execution activities, including data collection, field sampling, data trending, statistical analysis, deviation assessment, root cause investigations, and implementation of corrective actions.
  • Monitoring, tracking, and communicating validation project status, risks, and deliverables to project teams and leadership.
• Develop and scientifically justify validation strategies, acceptance criteria, sampling plans, and protocol designs based on risk management principles, process understanding, and industry best practices.
• Evaluate and document the impact of change controls on qualified systems, validated processes, facilities, utilities, and computerized systems, ensuring compliance with site and regulatory requirements.
• Lead and support investigations, deviations, and CAPAs, providing technical expertise to resolve complex quality, validation, and manufacturing issues.
• Develop, implement, and continuously improve validation procedures, standards, policies, and lifecycle management practices aligned with regulatory expectations and industry trends.
• Maintain compliance with current global regulatory requirements and industry guidance, including but not limited to:
  • 21 CFR Parts 210, 211, and 11
  • EU GMP Annex 11 and Annex 15
  • ICH Q8, Q9, and Q10
  • ISPE Baseline Guides and GAMP 5
  • Applicable domestic and international regulatory standards
• Manage multiple high-priority projects simultaneously, balancing competing demands while consistently meeting aggressive timelines and business objectives.
• Perform other duties and special projects as assigned.

Requirements:

• Bachelor's degree in Engineering, Biology, Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
• 3-5 years’ experience in pharmaceutical or regulated manufacturing environment; ideally, the candidate will have previous Oral Solid Dose (OSD) manufacturing experience.

Work Methodology:

• Professional services agreement (independent contractor)
• Full time job
• Full on site job in Vega Baja, Puerto Rico
• Languages: Spanish and English
• Type of industry: Pharmaceutical
• Expected hiring date:  August 2026
• Project term: 6-12 months with potential extensions
• Amount of openings: 4
• Administrative shift, wiling to support non-admin hours