Job description: Facilities Sr. Validation Engineer
The Facilities and Validation Sr. Engineer will lead the planning, execution, and oversight of facilities infrastructure projects and equipment validation processes within a regulated manufacturing environment. This role involves managing capital projects, coordinating contractors, maintaining critical facility systems, and ensuring equipment validation (IQ, OQ, PQ) complies with industry standards. The ideal candidate will bring strong facilities' equipment validation, project management, technical expertise, and a proactive approach to driving operational excellence and facility reliability.
Key Responsibilities:
Validation & Compliance:
Execute validation protocols (IQ, OQ, PQ) for new and existing equipment and processes.
Ensure compliance with regulatory standards (FDA, ISO) and company SOPs.
Maintain accurate and up-to-date documentation of validation and facility system changes.
Interface with quality and regulatory departments during audits and inspections.
Project Management & Planning:
Prepare business cases and present project proposals to senior leadership.
Manage facilities and maintenance capital projects. Developing detailed project schedules, defining dates and milestones, and tracking deliverables.
Conduct bids, negotiate with vendors, and ensure timely procurement of equipment and materials.
Maintain rigorous cost control and budget tracking; prepare project cost estimates.
Monitor contractors to ensure adherence to timelines, scope, compliance, and quality standards.
Facilities & Maintenance Oversight:
Oversee construction and facility upgrade projects from initiation through completion.
Maintain and troubleshoot systems, including HVAC, cleanroom air control, sterilization systems, nitrogen plants, compressed air, water purification, water heaters, fire protection, and manufacturing equipment.
Conduct safety walks and inspections; enforce adherence to EHS standards.
Support facility stabilization and improvement initiatives to meet production and reliability goals.
Collaboration & Communication:
Facilitate communications across departments, contractors, and stakeholders.
Participate in validation design reviews, progress meetings, and issue resolution.
Coach and advise contractors and team members to uphold safety and compliance standards.
Provide technical support during shutdowns or holiday upgrades when necessary.
Qualifications:
Education:
Bachelor's degree in engineering or related technical field.
Experience:
5+ years in facilities engineering and validation in a regulated manufacturing environment.
Strong knowledge of facility systems (HVAC, compressed air, water systems, cleanrooms, etc.).
Experience with equipment validation (Risk Assessment, FAT, CSV, IQ, OQ, and PQ).
Familiarity with project management methodologies and capital project execution.
Technical Skills:
Proficiency in Microsoft Office (Excel, PowerPoint, Project, Word), AutoCAD.
Advanced Excel and PowerPoint skills are highly preferred.
Understanding of PMO processes and tools; experience with KPIs and reporting.
Soft Skills:
Strong analytical, organizational, and problem-solving skills.
Effective communicator in both written and verbal English.
Team player able to lead a cross-functional team when needed.
Certifications (Preferred):
PMP, Lean Six Sigma Black Belt, FPX training, or equivalent.