Engineering and Maintenance Technician IV

Lantheus is headquartered in Bedford, Massachusetts with a state-of-the-art radioactive and non-radioactive manufacturing campus in North Billerica, MA. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.

Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone’s health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.

Job Summary

This role will report to the Associate Director of Manufacturing Technical Services within the Manufacturing Engineering organization to provide in-person high-level technical support to manufacturing to ensure product manufacturing schedules are met. Major systems in scope include Vial Filling, Inspection, and Labeling, support systems such as CIP and SIP systems, Parts Washers, Autoclaves and clean utilities such as clean compressed air, vacuum skids, RO and WFI water systems, and Clean Steam. The primary focus of this lead technical role will be support of the Isolated Vial Filling line and providing in person support on 2nd shift during manufacturing campaigns (20 runs per year, typically M-W 1800 – 0600 and R 1800 – 2200).

Key Responsibilities / Essential Functions

· Possesses all process understanding and troubleshooting skills associated with Engineering & Maintenance Technician III in addition to the following area specific responsibilities.

· Acts as liaison for Process Support in the support, development and implementation of capital projects within the manufacturing environment through technical input and resource management.

· Manages/Supports all non-capital based projects designated to the Process Support Team ensuring effective scope development, planning, implementation and close-out.

· Continuously monitors manufacturing processes with the focus on sustainability and reliability. Escalates high risk equipment related concerns to the appropriate action plans.

· Partners with Product Support, Process Engineering and Validation to maintain cross functional working relationships and to maintain a pulse on operations as it pertains to product and customer impact resulting from equipment performance.

· Writes, reviews, and updates job plans, preventive maintenance tasks and procedures. Initiates maintenance procedure development and implementation, updates standard operating procedures as needed.

· Provides emergency response to all production related events within the realm of responsibility for Process Support that cannot be resolved through on call responders.

· Is heavily involved with the production support team focused on line balancing, lean manufacturing and making necessary equipment/design improvements to eliminate downtime and yield loss

· Capitalizes on personal emergency response events as a development tool and applies a lesson learned type approach.

· Demonstrates subject matter expert level knowledge of manufacturing processes and equipment and is capable of leveraging these traits to support the development of other team members.

· Provides direct technical support to manufacturing processes in a JIT environment taking necessary actions to fully support manufacturing schedules, meet product delivery goals and ensure product compliance.

· Proactively monitors systems performance through application of process performance tools (SIC, Metrics etc.), Identifies opportunity for improvements in reliability, repeatability and efficiency. Effectively communicates and applies improvements with full compliance to MA DPS, OSHA, cGMP, FDA and NRC regulations utilizing standard practices/ procedures for documenting changes and testing.

· Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety and environmental hazards.

· Actively demonstrates the Lantheus values of accountability, collaboration, customer service, efficiency, quality, and safety.

· Demonstrates excellent attention to detail, organizational skills, and rigorous process discipline

Basic Qualifications

· BS in Mechanical or Electronics Engineering or an AS with > 15 years related experience in a highly regulated manufacturing environment. Equivalent work or military experience will be considered in lieu of formal education.

· Ability to operate a wide variety of test equipment, power and hand tools for the mechanical/electrical diagnosis, repair and/or fabrication of systems and components.

· Ability to read and modify electrical schematics. P&ID and mechanical drawings.

· Ability to perform complex alignment and/or integration between parallel and cascading production processes to ensure precise material or process flow.

· Ability to manage Integration between control systems and processes.

Other Requirements

· Prior experience using a CMMS system as a work tracking and documenting system.

· Previous experience with PLC’s, HMI’s, Control Systems with the ability to design, install, program and apply as a troubleshooting tool. Experience should include knowledge of systems such as Allen Bradley, Siemens, Modicon and Wonderware.

· Excellent planning, organizing and project management skills.

· Possesses a high skill level in working in hazardous and controlled environments including radiological spaces, confined areas, elevated heights, clean rooms, steam plants etc.

· Possesses the minimum of a Massachusetts 2nd Class Fireman’s License.

· Possesses specific detailed knowledge of all areas within manufacturing operations (e.g. sterilization, pharmaceutical utilities, process simulation, component manufacture etc.)

· Proven performance record in a radiochemical/radiopharmaceutical support or development environment.

· Broad in-depth knowledge of automated processes and operations.

· Broad understanding of scientific principles related to existing processes and new process technologies.

· Demonstrated ability to continuously improve the manufacturing operation through innovative problem solving and proactive enhancements effectively utilizing appropriate monitoring tools within the confines of a regulated environment. Collects and analyzes equipment performance data to drive a continuous improvement culture.

· Demonstrated ability to communicate information effectively to all levels of the organization in a manner that drives performance and promotes productive relationships.

· In-depth knowledge of cGMPs, OSHA and site safety policies, radiation safety techniques and regulations.

· Demonstrated ability to lead projects and/or teams for highly complex activities.

· Demonstrated ability to lead and work independently with cross-functional groups in a complex, changing, and diverse environment.

· Possesses a high-level understanding of validation principles and methodology.

· Demonstrated ability to perform the duties of a Study Director for development or validation protocols.

· Support the development of design, startup and validation documents such as commissioning plans, User Requirement Specification (URS), Functional Requirement Specification (FRS) and Installation / Operational / Performance Qualifications (IQ, OQ, PQ)

· Ability to adapt quickly to changes in daily work plans and unplanned issues on equipment, maintaining a focus on productivity without compromising safety or quality.

· Utilizes manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues.

· Provide engineering and automation support related to the installation, commissioning, qualification, operation and maintenance of process automated equipment and systems within the pharmaceutical manufacturing facility.

· Utilizes the Computerized Maintenance Management System (CMMS) to effectively manage work activities as well as the maintenance work backlog. Coordinates the execution of maintenance work with calibrations of equipment or instruments.

· Interfaces with the appropriate departments to address deviations from the norm, out of specifications, potential product concerns related to maintenance issues. Defines and implements effective corrective actions and monitors post-implementation effectiveness

Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Lantheus is an E-Verify Employer in the United States. Lantheus will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at talentacquisition@lantheus.com.