Sharp Packaging Services
Director, Mechanical and Electrical Services
Sharp Packaging Services, Macungie, Pennsylvania, United States, 18062
Mechanical and Electrical Services Director
The Mechanical and Electrical Services Director provides strategic direction and technical leadership for the performance of a cGMP pharmaceutical production facility. Scope includes the overall responsibility for Mechanical and Electrical Services across the Sharp Services Allentown Campus and incumbent acts as the primary customer facing contact for technically related customer concerns. Maintains compliance with all procedures, policies, and regulations, ensures timely response to regulatory issues and inspection findings and ensures a skilled, versatile, compliant and flexible workforce is maintained within the operation. Essential duties and responsibilities include the following. Other duties may be assigned. Provide technical leadership at the Allentown Campus by developing strategies, processes, systems, procedures, and metrics to achieve a high level of equipment availability, reliability, and performance. Developing, and ensuring these requirements are met requires a strong background and understanding of current regulations, risk management and FMEA methodology, Good Engineering Practices, and guidelines and practices associated with CAPA and Quality Management Systems. Ensures alignment and coordination with other functions such as Project Engineering, Facilities Central Eng, Operations, Validation, Warehouse, Quality Assurance, Procurement, and Finance. Leads efforts of the organization across functional boundaries and works with peers across a matrixed organization. Represents the functional area to clients, auditors, and inspectors. Identifies technical and process solutions to improve Sharp's level of regulatory and quality compliance. Furthermore, providing support for technical solutions that can assist with ongoing continuous improvement efforts and solutions identified as part of an ongoing effort to reduce failures and errors. Provide leadership in technical skills and workmanship in conjunction with managers and supervisors. Ensures established training process for technical staff on the operation of equipment, good manufacturing practices, safety regulations, waste reduction and production standards. Develop, manage and maintain departmental budgets 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. Responsible for the development, execution, and management of the production facilities equipment Capital Plan and Site Master Plan. To include: - Development of Capital documentation as required - Vendor selection and management - Contractor and supplier management - Capital budgetary tracking and project management This position requires a strong analytical approach to risk, product quality, and resource management. The position requires collaboration with Customers, Sales, Account Management Quality and Operations to understand customer requirements, forecasts, order anomalies and/or patterns and understand and establish appropriate staffing and maintenance plans. Functions as the Subject Matter Expert (SME) for technically related processes/questions for the Allentown Site. This includes, but is not limited to: Works 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. Drives site level initiatives to improve production methods, equipment performance, quality of product, and resource usage across multiple departments and teams. Proactively manage across stakeholder groups to establish interdependencies, identify risks and resource constraints, and eliminate significant roadblocks in a timely fashion. Assess the current methodology and identify / rationalize gaps vs. best practices and continuously improve the process to support our aggressive production schedule. Provides direction for sites equipment maintenance in the production arena, ensuring maintenance is operating as per industry accepted best practices. This includes management of Equipment Management and Maintenance Repairs and Operating supplies (MRO) service providers. This position will work closely with both Facilities and the Central Engineering team to ensure alignment on all Site engineering related activities functions are aligned. Fosters effective internal partnerships with site Quality and Production Planning personnel. During internal and external (FDA) audits the candidate will field auditor questions and will hold ultimate responsibility for all technical functions on the campus, relative to compliance. Although this is not a "hands on" position, the candidate must be well versed in reading and understanding equipment drawings (electrical and mechanical), strong understanding of control systems, and be willing to assist site Managers during troubleshooting or process development activities. Work Hours: "Off-shift" and weekend work will rarely be required. However, as this position has final responsibility for all aspects of the Technical Group, expertise may be required. Travel: Travel between Sharp sites may be required in support of internal planning meetings. There may be an occasion to travel to a customer or equipment vendor site. All travel expenses will be reimbursed in accordance with company policy. Supervisory Responsibilities: Direct reports will consist of department managers and various engineering disciplines on a three-shift basis. Carries out management 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. Education and/or Experience: Degree in Mechanical, Electrical, and/or Controls Engineering discipline and 10 yrs of GMP/regulatory experience is preferred. An associates degree with the relevant experience may be considered. 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 or similar is a requirement. Candidate must have at least 10 years of experience in a pharmaceutical production environment. Must have a strong internal locus of control and high emotional intelligence (people skills). Must be able to author position papers, 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/or maintenance activities (on call). Interpersonal Skills: Strong collaboration and interpersonal skills. Must be willing to challenge the status quo while being collaborative to work with many functional departments. Strong organizational skills and planning skills required, able to juggle multiple priorities and deadlines. Calm under pressure - ability to work through obstacles and crisis effectively and calmly. Computer Skills: Knowledge of Microsoft Office Suite including Word, Excel and Project. Demonstrated strength in comfortably troubleshooting in a heavily Mechatronics environment.
The Mechanical and Electrical Services Director provides strategic direction and technical leadership for the performance of a cGMP pharmaceutical production facility. Scope includes the overall responsibility for Mechanical and Electrical Services across the Sharp Services Allentown Campus and incumbent acts as the primary customer facing contact for technically related customer concerns. Maintains compliance with all procedures, policies, and regulations, ensures timely response to regulatory issues and inspection findings and ensures a skilled, versatile, compliant and flexible workforce is maintained within the operation. Essential duties and responsibilities include the following. Other duties may be assigned. Provide technical leadership at the Allentown Campus by developing strategies, processes, systems, procedures, and metrics to achieve a high level of equipment availability, reliability, and performance. Developing, and ensuring these requirements are met requires a strong background and understanding of current regulations, risk management and FMEA methodology, Good Engineering Practices, and guidelines and practices associated with CAPA and Quality Management Systems. Ensures alignment and coordination with other functions such as Project Engineering, Facilities Central Eng, Operations, Validation, Warehouse, Quality Assurance, Procurement, and Finance. Leads efforts of the organization across functional boundaries and works with peers across a matrixed organization. Represents the functional area to clients, auditors, and inspectors. Identifies technical and process solutions to improve Sharp's level of regulatory and quality compliance. Furthermore, providing support for technical solutions that can assist with ongoing continuous improvement efforts and solutions identified as part of an ongoing effort to reduce failures and errors. Provide leadership in technical skills and workmanship in conjunction with managers and supervisors. Ensures established training process for technical staff on the operation of equipment, good manufacturing practices, safety regulations, waste reduction and production standards. Develop, manage and maintain departmental budgets 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. Responsible for the development, execution, and management of the production facilities equipment Capital Plan and Site Master Plan. To include: - Development of Capital documentation as required - Vendor selection and management - Contractor and supplier management - Capital budgetary tracking and project management This position requires a strong analytical approach to risk, product quality, and resource management. The position requires collaboration with Customers, Sales, Account Management Quality and Operations to understand customer requirements, forecasts, order anomalies and/or patterns and understand and establish appropriate staffing and maintenance plans. Functions as the Subject Matter Expert (SME) for technically related processes/questions for the Allentown Site. This includes, but is not limited to: Works 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. Drives site level initiatives to improve production methods, equipment performance, quality of product, and resource usage across multiple departments and teams. Proactively manage across stakeholder groups to establish interdependencies, identify risks and resource constraints, and eliminate significant roadblocks in a timely fashion. Assess the current methodology and identify / rationalize gaps vs. best practices and continuously improve the process to support our aggressive production schedule. Provides direction for sites equipment maintenance in the production arena, ensuring maintenance is operating as per industry accepted best practices. This includes management of Equipment Management and Maintenance Repairs and Operating supplies (MRO) service providers. This position will work closely with both Facilities and the Central Engineering team to ensure alignment on all Site engineering related activities functions are aligned. Fosters effective internal partnerships with site Quality and Production Planning personnel. During internal and external (FDA) audits the candidate will field auditor questions and will hold ultimate responsibility for all technical functions on the campus, relative to compliance. Although this is not a "hands on" position, the candidate must be well versed in reading and understanding equipment drawings (electrical and mechanical), strong understanding of control systems, and be willing to assist site Managers during troubleshooting or process development activities. Work Hours: "Off-shift" and weekend work will rarely be required. However, as this position has final responsibility for all aspects of the Technical Group, expertise may be required. Travel: Travel between Sharp sites may be required in support of internal planning meetings. There may be an occasion to travel to a customer or equipment vendor site. All travel expenses will be reimbursed in accordance with company policy. Supervisory Responsibilities: Direct reports will consist of department managers and various engineering disciplines on a three-shift basis. Carries out management 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. Education and/or Experience: Degree in Mechanical, Electrical, and/or Controls Engineering discipline and 10 yrs of GMP/regulatory experience is preferred. An associates degree with the relevant experience may be considered. 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 or similar is a requirement. Candidate must have at least 10 years of experience in a pharmaceutical production environment. Must have a strong internal locus of control and high emotional intelligence (people skills). Must be able to author position papers, 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/or maintenance activities (on call). Interpersonal Skills: Strong collaboration and interpersonal skills. Must be willing to challenge the status quo while being collaborative to work with many functional departments. Strong organizational skills and planning skills required, able to juggle multiple priorities and deadlines. Calm under pressure - ability to work through obstacles and crisis effectively and calmly. Computer Skills: Knowledge of Microsoft Office Suite including Word, Excel and Project. Demonstrated strength in comfortably troubleshooting in a heavily Mechatronics environment.