We are seeking an experienced Validation Engineer to provide technical expertise in equipment validation within a laboratory support environment.
This role involves directing and troubleshooting validation projects, applying advanced engineering principles, developing innovative solutions to complex validation challenges, and leading initiatives for data security and data integrity assessments.
Responsibilities: Generate and execute Commissioning and Qualification protocols (IQ, OQ, PQ, as needed) for Laboratory Instrument and Equipment.
Equipment includes Analytical Balances, pH meters, HPLCs, PCR systems, Spectrophotometer (UV-VIS), Water Bath, Particle Counters, Air Samplers, TOC Analyzers, Mini Gel Tank / Roller, Densitometer / Scanner, Microplate Reader, Sonicator / Branson and LabX.
Coordinate work with engineers and/or technicians.
Employ advanced validation engineering techniques and adapt approaches for related assignments.
Collaborate with manufacturing, process development, utilities, facilities, labs, and quality assurance to define requirements and recommend solutions for complex projects.
Work with project managers to meet validation responsibilities within schedule, budget, and quality constraints.
Knowledge & Skills: Validation Expertise: Proficient in laboratory equipment qualification.
Problem-Solving: Develop innovative and practical solutions to complex technical problems.
Collaboration: Effectively interact with internal teams and external stakeholders, representing the organization on technical matters.
Guide successful completion of deliverables.
Technical Skills: Advanced knowledge of validation engineering principles.
Competencies: In-depth understanding of validation processes and regulatory requirements.
Effective communication and collaboration with diverse teams.
Strong problem-solving and analytical skills.
Requirements Education: Bachelor's degree with 5+ years of related experience.
Preferred Qualifications: Hands-on experience with analytical instruments.
Proven ability to manage multiple projects simultaneously.
Strong skills in negotiation, decision-making, conflict resolution, and leadership.
Expertise in vendor and contractor management.
Knowledge in Kneat Paperless Validation program (preferred, not a must) Shift: Standard shift; available for extended time depending on protocol execution