Lead Compliance Engineer
DescriptionJohnson & Johnson is currently recruiting for a Lead Compliance Engineer to be located in Athens, GA.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 https://www.jnj.com/.For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential. At Johnson & Johnson, we all belong.Responsible for the compliance and monitoring of facilities/engineering systems related to Good Manufacturing Practices (GMPs) of the Facilities and Utilities Operations thru the Integrated Facilities Management model, that includes the Hard and Soft Services (i.e. Utilities, janitorial, pest control and landscaping, Light maintenance and Security services. Responsible for Facilities Quality Systems, Investigations, CAPAs, trainings, SOPs, and internal/external audits compliance. Seasoned individual contributor in a scientific/technology field. Assesses new methods and strategies for facilities engineering schematics and layouts, as well as subsequent comprehensive supply chain outputs, in close alignment with departmental key performance metrics, goals, and objectives. Works collaboratively with management to develop and progress quality engineering strategies and methods to produce innovative customer-tailored engineering final work.The Lead, Infrastructure Assurance will provide quality oversight within the Tools and Infrastructure space. TQ&C guides teams throughout the building and execution of quality into enterprise-wide infrastructure tools, services through the end-to-end lifecycle (design, develop, implement, maintain, retire).Key Responsibilities:
• This role must ensure that all J&J quality and EHS&S standards and global regulatory requirements are being met.
• This role ensures that building execution activities include early involvement of quality in the design and development activities, building quality into the work product, building controls within the application/solution, and use of automation whenever feasible.
• This individual will lead the quality approach for systems and ensure teams are accountable for delivering on an end-to-end support model for systems in scope.
• Leads, under general direction, procedures for reviewing and ensuring ongoing monitoring of all Facilities Engineering project budgets, costs, and schedules to ensure customer-specific requirements are satisfactorily delivered within the customer’s required budget parameters.
• Confers with management on Facilities Engineering status updates and alignment to key completion timelines, relative to engineering layouts, project installation, and operational customer-specific requirements.
• Resolves issues outside contractors as required to successfully achieve project goals in accordance with applicable rules and regulations, with specific attention to issues of contractor safety and budgetary constraints.
• Helps establish rules to ensure that Facilities Engineering processes and procedures are in compliance with governing state and federal regulatory, safety, and quality protocols and standards.
• Coaches more junior colleagues in techniques, processes, and responsibilities.
• Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.
• Oversight of FM Service Provider daily performance and Site operational opportunities participating in the Tier 1, Tier 2, and Supervisor meetings as applicable. Identify recurrent opportunities in Site assets/ systems impacting Quality. Assign a root cause and create plan to mitigate/ eliminate the opportunity.
• Support developing, managing, and controlling the budget of the area of responsibility.
• Provide technical support to maintain the operating procedures up to date and oversight for strict compliance.
• Support participating in FM Governance Meetings and Processes including monthly SMT, inspections and similar.
• Supports major process including Instrumentation and facilities projects, including conducting project team.
• Supports in the installation, qualification, and validation of production equipment to be incorporated into the Manufacturing and/or Engineering Department.
• Organizes, maintains, and updates drawings of physical plant, mechanical, electrical, and equipment manuals for further reference when repairing the equipment.
• Ensures compliance with the ISO14001 Standards by reviewing the operation.
• Responsible for communicating business related issues or opportunities to next management level.
QualificationsEducation:
• Four to six (4-6) years of related experience and a University/Bachelor’s or equivalent degree in Computer Science, Information Systems, Business Administration, Engineering, or another related Technology/ Scientific field or a high school diploma and six to eight (6-8) years of related experience required
Experience and SkillsRequired:
• Basic management & supervision of both in-house and contracted personnel.
• Comprehensive knowledge in Investigations, CAPA, and RCA.
• Excellent communication and interpersonal relation skills.
• Must be a self-starter, able think creatively, challenge the norm and inspire change.
• Experience in change management and ability to collaborate and build strong partnerships internally & externally with customer focus.
• Prior experience in end-to-end technology qualification programs supporting infrastructure and enabling tools.
Preferred:
• Process improvement experience.
• Additional certifications are a plus.
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.For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
Pharmaceutical Manufacturing
Management and Manufacturing
Full-time