Facilities Engineer - Compliance (Grecia, Costa Rica)

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Supply Chain Engineering Job Sub Function: Facilities Engineering Job Category: Scientific/Technology All Job Posting Locations: Grecia, Costa Rica Job Description: "Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.” About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech About Orthopaedics Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech We are searching for the best talent for Facilities Engineer - Compliance. Purpose: Contributes to the Facilities team as an experienced individual contributor supporting engineering compliance, technical documentation, Facilities systems, projects, and continuous improvement activities within a regulated manufacturing environment. The position applies practical engineering knowledge and compliance principles to evaluate Facilities activities, systems, documentation, and changes against applicable quality, regulatory, technical, and operational requirements. Works with moderate supervision and supports risk-based decision making, investigations, change implementation, qualification activities, audits, and inspection readiness. Collaborates cross-functionally to maintain safe, reliable, compliant, and effective Facilities operations. You will be responsible for: In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines, this position: Leads Facilities engineering compliance activities within assigned areas of responsibility, ensuring Facilities systems, utilities, maintenance activities, engineering changes, and associated documentation are managed in accordance with applicable regulatory, quality, and Company requirements. Owns the development, review, revision, implementation, and lifecycle maintenance of Facilities procedures, forms, technical standards, records, and controlled documentation, ensuring appropriate technical content, traceability, and document control. Leads and documents technical risk assessments and quality impact evaluations for Facilities systems, projects, maintenance interventions, equipment failures, process changes, deviations, and operational events, determining appropriate compliance actions and escalation requirements. Provides Facilities technical compliance assessment for engineering and change control activities, defining applicable qualification, validation, documentation, testing, and implementation requirements necessary to maintain the qualified or validated state of impacted systems. Leads or provides Facilities technical expertise during investigations of deviations, nonconformances, system failures, recurring events, and compliance issues; supports root cause determination and develops technically sound corrective, preventive, and remediation actions. Coordinates and provides technical oversight of qualification, requalification, validation, commissioning, monitoring, and lifecycle compliance activities for applicable Facilities systems, critical utilities, cleanrooms, and controlled environments. Evaluates maintenance strategies and interventions for critical Facilities assets and utilities to ensure preventive and corrective maintenance activities remain aligned with quality requirements, system criticality, qualification commitments, technical risk, and the established state of control. Analyzes Facilities compliance and engineering data, system performance, maintenance records, deviations, monitoring results, and recurring events to identify adverse trends, systemic gaps, emerging technical risks, and opportunities for corrective or preventive improvement. Drives Facilities inspection readiness by assessing compliance status, identifying and remediating gaps, ensuring availability and accuracy of supporting evidence, and representing Facilities during applicable internal audits, external audits, inspections, and compliance assessments. Provides compliance oversight for Facilities engineering projects, system modifications, equipment replacement, commissioning, and operational readiness activities to ensure regulatory and quality requirements are incorporated throughout planning, execution, turnover, and implementation. Ensures Facilities records and technical data within the assigned scope are complete, accurate, attributable, traceable, and maintained in accordance with applicable documentation and data integrity requirements. Partners with Quality, Engineering, EHS, Manufacturing, Validation, Maintenance, and other applicable functions to resolve complex Facilities compliance issues and ensure that technical decisions appropriately consider product, process, regulatory, operational, and business impact. Serves as a Facilities compliance subject matter expert within assigned areas, providing technical guidance to Facilities personnel, service providers, contractors, and cross-functional teams on applicable compliance requirements, engineering controls, and documentation expectations. Identifies compliance vulnerabilities and opportunities to strengthen Facilities quality systems, engineering practices, maintenance controls, documentation, qualification strategies, and inspection readiness, and drives assigned remediation and continuous improvement initiatives to completion. Escalates significant compliance gaps, technical risks, recurring failures, adverse trends, or conditions that may affect the qualified or validated state of Faci