Johnson & Johnson is seeking a highly qualified and motivated individual to join our team as a Senior Process Engineer located in Añasco, PR. 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 Med Tech, 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 https://www.jnj.com/.   The Engineer handles most aspects of a project or initiatives. Role is responsible for problem identification, reporting, root cause analysis, project management, financial analysis, efficiency or productivity improvement, reporting, and problem resolution. Role interfaces directly with other departments, sites, and corporate functional groups to drive and/or support critical business goals/objectives within GMP/ISO compliance. Lead/Support continuous improvement activities to ensure business key performance indicators are met. Lead groups of Engineers or Technicians on projects or special assignments. Creates and presents CAR for the Projects responsible. Key Responsibilities: + Leads and executes projects and/or programs of moderate to high level of complexity ensuring safety, regulatory compliance, company standards, operation requirements and business needs. + Drive the optimization of process output and throughput, equipment utilization, equipment downtime, waste reduction/yield improvements, budget management, standard cost, and capital investment management in a creative manner. + Provides technical support to peers and production areas in evaluating process deficiencies, process changes, modifications, and equipment failure. Defines, analyzes, reviews, and evaluates problems for prompt solutions. + Sets the engineering standard and direction for the group and is recognized as the source for mentorship in a field. + Financial management and scheduling – Prepare project estimates for design, equipment, installation, labor, materials, and other related costs. Prepare project forecast, schedules, and tracks costs. + Challenges the “status quo” on a routine basis and develops new ideas within incoming processes. + Drive phases of work with different site functions and with other divisions. + Technical support for Non-conformance issues in the manufacturing area generating investigation reports and corrective action identification (Coordinates and participates on Multi-functional Investigation). + Supports manufacturing in the day-to-day troubleshooting of equipment’s to ensure increase production outputs and increase operation team capabilities. + Follows Standard Operating Procedures (SOP), Good Manufacturing Practices (GMPs), Company Policies and Federal, State and Local Government Regulations. + Revise and maintain engineering, equipment’s, and process procedure. + Support the GMP audits as subject matter guide for product and processes. + Coordinates communications and interfaces within end users and machine manufacturers or suppliers. + Lead or participates in projects involving other departments and activities. + Evaluates process trends (Ex. Yield, OEE) to drive improvements of business results. + Daily monitoring and support to manufacturing lines + Provide training on process and validation requirements to operators and engineers + Writes, develops, and execute validation strategies. + Works independently. Plans and develops own methods. Takes actions in the absence of specific instructions. Develops and presents new or improved methods. Solves manufacturing problems in a timely manner. **Qualifications** + Bachelor’s Degree in Engineering is required. + Minimum of 2 years of related work experience is required. + Experience in a maintenance manufacturing environment, R&D or Process Development, preferred. + Experience working at medical device industry or pharmaceutical, preferred. + Demonstrated experience in Project Management, preferred. + Knowledge in Control Systems, Automation and familiar with Vision Systems, preferred. + Experience in Computer Systems Validation, preferred. + Proven experience with validation cycle (FAT, IQ, OQ and PQ), preferred. + Performed Design Reviews with vendors on automated equipment. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.