Manager, Mechanical Services at Sharp Packaging Solutions, part of UDG Healthcare plc

Allentown, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

13 Feb, 26

Salary

0.0

Posted On

16 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Mechanical Engineering, Electrical Engineering, Controls Engineering, Mechatronics, Human-Machine Interface, Process and Instrumentation Diagrams, Programmable Logic Controllers, Allen Bradley PLCs, Siemens Apogee Insight, Technical Troubleshooting, Root Cause Analysis, Good Manufacturing Practices, Occupational Health and Safety, Continuous Improvement, Customer Interaction, Technical Documentation

Industry

Pharmaceutical Manufacturing

Description

SUMMARY: The Manager, Mechanical Services will function as the lead technical expert supporting all Equipment within multiple equipment trains located in that building. The primary responsibility of this position will be to ensure continuous safe and efficient operation of all equipment within the defined area of responsibility. Maintains a cGMP production environment and standards throughout the production area(s). Adheres to workplace environmental, health and safety (EHS) guidelines and procedures while actively promoting and enforcing adherence. This is a customer-facing role and customer interaction will be a part of daily activities. Essential Duties will require a close-knit integration with various departments including Quality, Validation, Engineering, etc., and the extended team comprised of non-Sharp employees. New business and continuous improvement team member duties, including root cause analysis, corrective action and risk assessment team involvement. ESSENTIAL DUTIES AND RESPONSIBILITIES: The following is a list of minimum responsibilities related to the Manager, Mechanical Services position. Other duties may also be assigned. Function as the technical expert for all equipment within the defined area of responsibility, leads technical troubleshooting and problem-solving efforts when required. Ensure continuous safe and efficient operation of equipment according to established parameters. Actively participates and ensures adherence to Company policies and programs on occupational health, safety and good manufacturing practices (GMP) procedures. Provide leadership in technical skills and workmanship in conjunction with mechanical supervisors and lead mechanics. Ensures established training process for mechanics on the operation of equipment, good manufacturing practices, safety regulations, waste reduction and production standards. Develop, manage and maintain Mechanical Services budget for area of responsibility by partnering with Ops/QA and procurement to ensure critical parts and supplies are on hand to minimize any downtime while simultaneously demonstrating fiscal accountability. Work closely with Customers, Sales, Account Management and Operations to understand customer requirements, forecasts, order anomalies and/or patterns and establish appropriate staffing and maintenance plans. Function as the Subject Matter Expert (SME) for technically related processes/questions within the scope of responsibilities. This includes, but is not limited to: Work closely with Sharp’s business partners to ensure that our client’s goals are met or exceeded. This may include supporting equipment testing, product sample coordination, and implementing upgrades per continuous improvement initiatives. Author technical documents such as Change Controls and WRKI’s, Review MPR’s etc. Technical analysis of root cause and corrective action establishment during event investigations. Ability to take ownership and drive corrective actions including documentation updates, Change Control development, and equipment system upgrades. The ability to travel internationally as part of an extended team to support new equipment purchases when necessary. Manage site Technicians and external service contractors to ensure timely corrective and planned maintenance activities are completed as required. This position will work closely with the Facilities Team to align all facilities-related functions. Included are maintenance schedules, preferred contractors and BAS requirements. Recommend measures (CI) to improve production methods, equipment performance and quality of product. Establishes or adjusts work procedures to improve quality, productivity and meet production schedules. Analyzes and resolves work problems or assists workers in solving work problems through participation in continuous improvement activities. Foster effective internal partnerships with site Quality and Production Planning personnel. During internal and external (FDA) audits the candidate will field auditor questions and will be required to provide an overview of the technical functions in question. This role requires a great deal of interaction and support where the work takes place in the actual production rooms. Candidate must be well versed in reading and understanding equipment drawings (electrical and mechanical) and be willing to assist site Technicians during troubleshooting activities. QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. SUPERVISORY RESPONSIBILITIES: Directly manages mechanic supervisors and mechanics over a three-shift basis. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, training employees, planning, assigning, directing work, appraising performance, rewarding, disciplining employees, addressing complaints and resolving problems. PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE: Candidate must possess at minimum an associate degree in mechanical, Electrical, and/or Controls Engineering. Extensive related experience of greater than 10 years in a food/nutraceutical/cGMP industry will be considered as an equivalent. Must have prior experience in manufacturing engineering. Specifically, demonstrated strengths in Mechatronics, Human-Machine Interface (HMI), Process and Instrumentation Diagrams (PNID) & Programmable Logic Controllers (PLCs) Familiarity with Allen Bradley PLC’s and Siemens Apogee Insight (Building Automation System) or similar is a requirement. Candidate must have at least five years of experience in a production environment. Pharmaceutical experience is a plus. Must have a strong internal locus of control and high emotional intelligence (people skills). Must be able to write legibly, be able to verbally communicate clearly and concisely, and follow procedures. Must be flexible in executing responsibilities. This is a minimum 40-hour a week job that will require flexibility and off-hour support during technical breakdowns and maintenance activities (on call). PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to stand, walk; use hands to finger, handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and ability to adjust focus. WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly exposed to moving mechanical parts. The noise level in the work environment is usually moderate. DISCLAIMER: This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice. Sharp Packaging Services works across the world to create unique commercial and clinical packaging solutions for the pharmaceutical and biotechnology industry. We are made up of two dynamic international divisions, Sharp Packaging Solutions and Sharp Clinical Services. Together our 1,600-strong team works from state-of-the-art facilities in the United States, United Kingdom, Belgium and the Netherlands. We’ve built an exceptional global reputation for the design, serialisation and production of innovative, cost-effective compliance packaging for even the most complex products. Our extensive range includes blister packs, bottles, pouches and stick packs, but our expertise goes far beyond, enabling us to support your product through every stage of design, development, manufacture and delivery. Our clinical services division is one of the world’s leading providers of innovative clinical supply chain services, with a talented and highly experienced team that can handle every aspect of your supply chain. Our work spans everything from drug development and manufacturing to clinical supplies packaging, labelling, distribution, Qualified Person auditing and comparator sourcing.

Responsibilities

The Manager, Mechanical Services will lead technical support for equipment within multiple equipment trains, ensuring safe and efficient operations. This role involves close collaboration with various departments and managing mechanical supervisors and technicians.