Validation Engineer
Title: Validation Engineer
Location: North of Puerto Rico (Only for Puerto Rico Residents)
Experience / Qualifications:
• Bachelor's degree in Engineering, Biology, Chemistry, Pharmaceutical Sciences, or a related
scientific discipline.
• Senior Qualification & Validation Engineer: Candidate should have 7-10 years’ experience in
pharmaceutical or regulated manufacturing environment; ideally, the candidate will have
previous Oral Solid Dose (OSD) manufacturing experience.
• Qualification & Validation Engineer II: Candidate should have 3-5 years’ experience in
pharmaceutical or regulated manufacturing environment; ideally, the candidate will have
previous Oral Solid Dose (OSD) manufacturing experience.
• Validation Engineer I: Candidate should have 0-3 years’ experience in pharmaceutical or
regulated manufacturing environment; ideally, the candidate will have previous Oral Solid
Dose (OSD) manufacturing experience.
Key Competencies:
1. Provide technical leadership for commissioning, qualification, and computer system validation
activities, including:
a. Leading and executing end-to-end qualification and lifecycle management of facilities,
utilities, manufacturing equipment, process systems, and computerized systems.
b. Planning, coordinating, and delivering qualification and validation project
milestones within scope, timeline, and budget constraints.
c. Developing, reviewing, approving, and executing validation lifecycle documentation,
including Validation Master Plans, User Requirements Specifications (URS), Functional and
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Design Specifications, Risk Assessments, Commissioning Plans, IQ/OQ/PQ protocols, and
summary reports.
d. Directing protocol execution activities, including data collection, field sampling, data
trending, statistical analysis, deviation assessment, root cause investigations, and
implementation of corrective actions.
e. Monitoring, tracking, and communicating validation project status, risks, and
deliverables to project teams and leadership.
2. Develop and scientifically justify validation strategies, acceptance criteria, sampling plans, and
protocol designs based on risk management principles, process understanding, and industry best
practices.
3. 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.
4. Lead and support investigations, deviations, and CAPAs, providing technical expertise to resolve
complex quality, validation, and manufacturing issues.
5. Develop, implement, and continuously improve validation procedures, standards, policies, and
lifecycle management practices aligned with regulatory expectations and industry trends.
6. Maintain compliance with current global regulatory requirements and industry guidance, including
but not limited to:
a. 21 CFR Parts 210, 211, and 11
b. EU GMP Annex 11 and Annex 15
c. ICH Q8, Q9, and Q10
d. ISPE Baseline Guides and GAMP 5
e. Applicable domestic and international regulatory standards
7. Manage multiple high-priority projects simultaneously, balancing competing demands while
consistently meeting aggressive timelines and business objectives.
8. Perform other duties and special projects as assigned.
1. Support the execution of commissioning, qualification, and validation activities for manufacturing
equipment, facilities, utilities, and computerized systems.
2. Assist with the development, review, and execution of qualification and validation
documentation, including Validation plans, Risk assessments, Commissioning documents, IQ, OQ,
and PQ protocols, Test scripts, Final reports
3. Participate in protocol execution activities, including:
a. Data collection and documentation
b. Equipment testing and verification
c. Utility and environmental monitoring support
d. Sample collection
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e. Recording and compilation of results
4. Analyze test data, identify discrepancies, and assist in troubleshooting qualification and validation
issues under the direction of senior personnel.
5. Maintain validation documentation and ensure records are complete, accurate, and compliant
with data integrity requirements.
Basic understanding of cGMP regulations and pharmaceutical manufacturing principles