Location: Mahwah, NJ
Company: Sean Ryan Associates
Engineering jobs encompass various roles focused on designing, developing, and maintaining structures, machines, devices, systems, and materials. These positions require a strong foundation in STEM (Science, Technology, Engineering, Mathematics) and often involve problem-solving, creativity, and technical expertise. Typical engineering disciplines include civil, mechanical, electrical, and chemical engineering, among others. Engineers work in diverse industries, from automotive to aerospace, construction to computing. Characteristics of engineering jobs include a blend of theoretical knowledge and practical application, a commitment to safety and efficiency, and the likelihood of collaborating across multidisciplinary teams.
of medicine. We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company. The Site Head of Operations develops and implements a variety of strategies to maximize revenue while maintaining the highest level of quality, as well as working on improving the manufacturing operation to positively impact cost, quality and delivery time.
The Site Head of Operations provides oversight and guidance to subordinates as well as timely feedback to department leaders on operations-related issues, demonstrating a thorough knowledge of the company's services, clients projects in addition to regulations and industry
best practices. ESSENTIAL FUNCTIONS AND RESPONSIBILITES Directly accountable for the Manufacturing, Engineering and Facilities Operations, Environmental Health and Safety, Supply Chain, Validation, Manufacturing Science and Technology, Project Management and Human Resources for the site operations.
Indirectly accountable for the Quality Assurance and Quality Control, from a business direction, informational respect and regulatory guidance. Develops and implements operational strategy for the site including (but not limited to) appropriate budget, investment, staffing and accurate reporting of billable and non-billable hours for all client projects. Assists the Technical Operation head
and the Leadership team in the implementation of Quality and Business processes required to assure compliant c GMP (current Good Manufacturing Practices) manufacturing of clients products in either a clinical or commercial setting on time and within budget.
Monitors manufacturing capacities and communicates capabilities to the Business Leaders and Business Development for future opportunities. Assures staff has the proper training, skill set, and personal development opportunities to assure their ability to carry out assigned tasks in compliance with HCATS procedures and policy as well as local, federal and global regulations and industry standard. Assists in the development, execution and monthly tracking and reporting of assigned operational metrics.
Works collaboratively with Quality Assurance, Quality Controls and Regulatory Affairs, Process Development, Global MSAT and Business Development, to ensure site and corporate goals are met. Develops and implements a continual Audit of the site for GMP, Safety, good housekeeping and compliance. Support EHS (Environmental, Health, and Safety) Manager to assure environmental and OSHA (Occupational Safety and Health Administration) compliance by developing appropriate safety, compliance, quality, and other relevant policies, procedures, goals and metrics.
Accountable for ensuring the assigned plant consistently meets all c GMP and other regulatory requirements. Assures operations area is kept in a c GMP state of repair through coordination of preventive maintenance and cleaning activities with the Facilities department. Develops site recapitalization plan to ensure the site operations is stable and profitable. Responsible for ongoing development and improvement of the infrastructure necessary for the assigned plant to effectively and efficiently deliver against its vision, strategy, plans and objectives.
Builds a world-class team, develops talent and ensures a robust succession plan is in place, at all times for key positions in the plant. Develops a continuous improvement culture within the team. Drives and oversees regular and ad hoc risk backssment and mitigation planning and management. Leads and/or participates in various cross-functional teams or committees, e. g. Quality Task Force, S&OP (Sales and Operations Planning) and, Revenue & Resource. Develops and executes plans to meet or exceed manufacturing efficiency targets for clients. Interfaces with senior managers, peers and direct reports to maintain mutual understanding of productdesign needs, regulatory and production requirements.
Works closely with internal and exteal colleagues on projects of existing and new products to ensure appropriate capacity, improve quality, adequate sourcing of critical components. Works to assure annual revenue targets are met by overseeing financial responsibilities which are within the positions control such as staffing, line item expense, capital requirements, capacity utilization. Support MSAT Process Development, Product Stewardship and Manufacturing Support groups to ensure smooth tech transfer of new products.
Responsible for the initiation and deployment of site process improvement objectives and build the foundations to drive continuous, sustainable, flawless execution and performance through the application of operational excellence principles. Competencies/Candidate Profile Highly intelligent, perceptive individual who possesses excellent conceptual, analytical, and problem-solving ability. Ability to effectively interface with peer group in the company and work collaboratively to achievecompany goals. Collaborates with other team members and demonstrates outstanding interpersonal skills.
Ability to work autonomously in an entrepreneurial, fast paced environment. Strong business acumen Ability to think strategically and tactically (detail-oriented)Flexible and able to adapt to company growth and evolving responsibilities. Supervisory Responsibility This position requires the management of personnel from Sr. Director Level and below. Working Environment The job requires communication with the site leadership during and after working hours as well as working with challenging clients, contractors and advisory personnel. Physical Requirements While performing the duties of this job, the employee is occasionally required to stand; walk; sit; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear.
The employee must frequently lift and /ormove up to 15 pounds and occasionally lift and/or move up to 50 pounds Direct Reports Manufacturing Leader Supply Chain Leader Facilities Operation Leader Human Resources manager Project managers Validation managers MSAT Leader EHS officer Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job.
Duties, responsibilities, and activities may change at any time with or without notice. Shift Details: Monday-Friday, Day Shift (8:00AM-4:30 PM)
and maintains policies and procedures to comply with safety laws, regulations and standards. - Works with environmental specialist and industrial hygienist to implement and maintain policies and procedures to comply health and environmental laws, regulations and standards.
Drive incident investigations to identify root cause and corrective/preventive actions - Develops and maintains safety management policies and procedures necessary for the plant. - Coordinates and supports plant safety, health and environment management program and initiatives. Be a visual presence on the production floor and provide counsel, advice and support to other functions on all safety, health and environmental
and security related matters. - Identifies at risk behaviors and eliminate and/or mitigate. - Leads and participates in environmental, health and safety inspections, backssments and audits and track corrective actions to closure.
- Liaison between the company and safety related governmental authorities, agencies, committees or professional services. - Supports the management of change (MOC) process as a change owner, subject matter specialist (safety) and change action owner. - Coordinate and conduct EH&S required training in accordance with Du Pont, local, state and federal regulations. Minimum Qualification - Minimum University Degree in Safety Sciences, Engineering or related major.
- Minimum Five years professional experience in manufacturing or industrial setting.
- Organizational priority-setting skills, attention to detail, follow-through, effective written and verbal communication skills in English. - Ability to build consensus and influence a diverse group of associates in safe behaviors and practices - Ability to work independently, contribute within a team, and actively engage and partner with manufacturing and technical associates - Ability to work off-shift hours, if needed, and local travel up to 10% Training Identified General Employee Orientation Ethics People Treatment HR Policy Soft Skills Communication Skills Presentation Leadership Supplemental Microsoft Office Applications SHE Specific Project implementation OSHA Safety Regulations (OSHA 30-hour training preferred)This location is in growth mode - going to expand and build a new plant 259 employees and 60 contractors Candidates need to come out of chemicals or oil/gas
products and solutions that aim to improve clinical results and optimize workflows. Every day we collaborate to make a true difference for our customers - and to save more lives. Are you looking for an inspiring career? You just found it. Lead and coordinate efforts for engineering support to the manufacturing areas in equipment design, process improvements, cost improvements, process troubleshooting and compliance efforts.
The qualified applicants will be responsible for the following: Coordinate projects and lead junior engineers in the development, qualification, and implementation of new or modified products or processes. Prepares technical reports, analysis, recommendations and
presentations reflecting the status and results of projects in progress on a regular basis Draft protocols and manage all phases of equipment and process validations.
Lead efforts for re-design, repair or replacement of in-process production program equipment and tooling. Develop processes, methods, tooling and production controls for new equipment. Evaluates internal and external technologies to solve complex problems. Prepare capital appropriation requests providing required evaluation, analysis and supporting justification. May supervise other technicians and engineers. This is not an inclusive list of job responsibilities. The ideal candidate must have: This position requires
a Bachelor's degree (or equivalent) in Chemical, Mechanical, or Biomedical Engineering or other related technical degree.
A Master's degree in Engineering is preferred. A minimum of 5 years in manufacturing and/or process engineering required or Master's degree plus 3 years. Seven to ten years' experience in the medical device, medical, textile or other FDA regulated industry is ideal. Previous experience in the Class III implantable industry would be a definite plus. Required Knowledge, Skills and Abilities: Previous working knowledge in the following areas is required: design control, remediation, manufacturing process support, and process development.
Experience with design and process FMEAs is highly desirable. Working knowledge with continuous improvement processes, Kanban, equipment design, re-tooling, re-engineering and automation of production processes is a plus. Position requires a sound statistical background. Must have experience performing various types of statistical analysis and be able to demonstrate expertise and leadership in the use of statistical analysis techniques. Experience with DOEs is highly desirable. Ability to manage complex projects and multiple priorities is required. Must be able to drive results and work effectively in a team setting.
Previous supervisory experience is a plus. Must demonstrate effective verbal and written communication and the ability to make presentations to all levels of the organization. Must demonstrate sound judgment, be well organized, take initiative, and be flexible. Must demonstrate ability to work well under pressure, work effectively with both employees and management and be able to facilitate resolution of fairly complex issues. Proficiency with Microsoft Office, Solid Works, Mini Tab or equivalent software applications is preferred. Previous working knowledge of SAP or equivalent system is highly desirable.
Salary Range: $95k - $125K Remote Work: 1-2 days Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: Health, Dental, and Vision insurance benefits 401k plan with company match Paid Time Off Wellness initiative & Health Assistance Resources Life Insurance Health and Dependent Care Flexible Spending Accounts Commuter Benefits Parental and Caregiver Leave Getinge is on an exciting transformation journey constantly looking for new ways to innovate together with our customers to meet the healthcare challenges of the future.
Our passionate people hold our brand promise 'Passion for Life' close to heart. Interested candidates please apply. Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. We look forward to receiving your application. If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application.
We hope you will join us on our journey to become the world's most desired medtech company. INDLGPDN-9adbc-9798-a1e3cb921c55
a strong safety and productive culture. This role leads the site Maintenance, Reliability, and Automation and Process Control organizations. The primary role of the Site Maintenance Leader is to provide area leadership to ensure integration of Technology, Production, Maintenance, Capital, and Contract organizations as it relates to the maintaining of the facility (assets).
Their secondary role is to ensure alignment of all personnel placed under their charge to perform all maintenance and reliability activities for those assets. The Maintenance and Reliability Leader ensures maintenance work is performed in compliance with safety, health, and regulatory requirements. RESPONSIBILITIES:
Accountable for leading the organization, collaborating with other resources and work processes, and delivering Safety, Reliability and Maintenance cost optimization results Leverages the Global Maintenance Work Process and Sub-Processes across multiple operating units (leverage across site)Responsible for developing and leading the facility maintenance strategy.
Accountable for implementing Equipment Maintenance Strategies. Accountable for the overall application of the Maintain Facility Work Process and overall alignment to the business' needs. Ensures effective linkages with other processes Responsible for implementation and ongoing support of the Maintenance Procedure Use Policy at
the facility. Executes the performance management system Drives emergence of culture and desired behavior analyzes and audits work process results Responsible for Site Reliability Metrics and Business Reliability Metrics Accountable for the development and implementation of a Quality Control plan for repair of critical equipment including repair specification, inspection plan and startup procedure Promotes the Leveraging of most effective technology through partnership with the Businesses and functions Demands use of the Management of Change for value added improvements Optimizes the interface to other work processes within the business, area or site Liaison between business and site maintenance organization collaborating on strategy implementation and respective metrics.
Initiates and participates in Facility Condition backssments to ensure consistency of approach. Defines necessary technology Equipment Maintenance Strategies and collaborates with Sites on definition and implementation of strategies. Leads collaboration with Global Improvement Leader(s) within the Business Technology Center to develop the comprehensive asset strategy which integrates maintenance, investment, and technology deployment to meet the business strategy Leads Contract Administration QUALIFICATIONS: BA/BS degree in Engineering, a masters degree is preferred.
Other BA/BS degrees considered. Minimum of 5 years of manufacturing experience or related fields. Strong Microsoft Office skills (Excel, Power Point, etc. )Good problem-solving ability/ Teamwork oriented Demonstrated skill in verbal and written communications, planning and organizing. Strong Project Management skills and the ability to manage/balance a large workloadis an equal opportunity employer. Qualified applicants will be considered without regard to race, color, religion, creed, interaction, interactionual orientation, gender identity, marital status, national origin, age, veteran status, disability or any other protected class.
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