Manufacturing Automation Engineer

The Engineering Lead, Automation will provide Technical Leadership to the Systems Engineering group. Responsible for the overall business and manufacturing systems and related infrastructure. Responsibilities include the planning, implementation and support to manufacturing, administration, packaging, facilities, utilities and laboratory systems technologies and remote locations. Provide leadership in the development and implementation of a framework and methodology for Computerized Systems Validation (CSV) in compliance with current Good Manufacturing Practices (cGMPs). Complies with safety and environmental regulations to ensure execution, compliance, and proper reporting.

Responsibilities: Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and policies, procedures and guidelines, this position:

• Attends GMP trainings on the schedule designated for the role.
• Adheres to strict compliance with procedures applicable to the role.
• Exercises the highest level of integrity in the tasks performed.
• In a timely and prompt manner, identifies reports and seeks correction for deviations noted in the workplace.
• Embraces a behavior of employee involvement and commitment to doing the job right the first time.

People Managers:

• Ensures employees under the scope of responsibility are trained in required procedures for the execution of their role and maintains current with training requirements during the year.
• Promotes an environment of employee involvement in the workplace.
• Seeks prompt identification, reporting and correction of deviations in the workplace as noted by employees.
• Assures trainings in the assigned curricula have been completed prior to execution.
• Acts in accordance with the principles expressed in Our Credo in all negotiations and activities within and outside the company and assures these are met.

Environmental, Health and Safety (EHS):

• Comply with the requirements established in the Environmental Health and Safety (EHS) Program and the ISO 14001 Standard, including:
• Complies with EHS trainings, policies and procedures.
• Maintains a safe area and work environment by following and encouraging the following rules and procedures.
• Promotes employee participation in the activities and requirements of the site’s Environmental
• Management System (ISO 14001), Process Safety Management and other initiatives in the EHS program (applies to management level).
• Participates in the site’s waste reduction and recycling program.
• Participates in energy reduction and other initiatives to protect and promote environmental protection.
• Guarantees his/her behavior is safe in the work area.
• Actively participates to achieve the organization’s EHS goals/objectives.
• Monitors the EHS performance within the work area (applies to supervisors and managers).
• Adheres to the EHS business plan for the work area.
• Notifies and/or initiates corrective action plans for unsafe working conditions or risks in the work area.
• Immediately notifies the supervisor of any incident or accident that occurs in the company, including injury and/or occupational illness. The supervisor/manager submits an Incident Report within 24 hours of the accident.

Actively participates in the Ergonomic Exercise Program of the work area.

• Provides the necessary resources and assures to complete on time any safety related matter (applies to supervisors and managers).

Area Responsibilities: Manages System Engineering at the Manufacturing Plant.

• Support Company operations through the efficient and cost-effective deployment and use of information technology at the manufacturing, administration, utilities, facilities and QA Laboratory areas.
• Develops and implements both strategic and tactical business plans to ensure continuous improvement in the use of information technology throughout the business.
• Prepares, administers, and controls System Engineering forecast and department budget.
• Provides Systems Engineering and technical support to all the Lititz Plant departments, 24 hours a day/ 7 day a week.
• Manages the development and review of department standard operating procedures (SOPs) and works instructions to meet company requirements in the areas of control, security and baseline functions.
• Stays up to date of technological advances in computing technology, manufacturing automation, and communication systems related to regulatory issues.
• Evaluates and recommends new technological solutions to improve business operational efficiency, productivity, and regulatory compliance.
• Provides leadership in the development and implementation of a framework and a methodology for computerized systems Validation (CSV) in compliance with current Good Manufacturing Practices (cGMPs).
• Manages projects to ensure their success and timely completion.
• Recruits, hires, evaluates, supervises, rewards, and, when required, disciplines assigned staff.
• Plans and encourages the professional development of assigned staff to ensure their talents and abilities are developed to their fullest potential and are applied enthusiastically to the achievement of company goals.
• Responsible for the oversight of project work involving the planning, implementation, validation, and support of cGMPs computerized systems that fall under the category of Plant Support Systems: such as, Supervisor Control and Data Acquisition (SCADA), Laboratory Information Systems (LIMS), programmable Logic Controller software applications, Building Management System and Plant Security Systems.
• Assure all aspects of assigned engineering projects, including:
• Evaluation of new systems and equipment.
• Writing of justifications and appropriation requests.
• Performing financial analyses.
• Managing outside engineers and consultants.
• Identifying/preparing required pe1mits and ensuring compliance with applicable regulations.
• Coordinating project activities.
• Ensure completion and approval of project documentation, including qualification and validation protocols, standard operating procedures, work instructions and calibration/preventive maintenance procedures.
• Controlling expenditures of capital and expense funds within approved budget. • Training on process / equipment operation.
• Following up to ensure that project objectives are met.
• Provides technical support to the technical areas.
• Prepares reports for presentation to management and makes presentations to various levels of management as required.
• Responsible for the review and approved process of all computer validation documents within the plant. Review drawings, layouts, specification, and conceptual designs as required.. Responsible for the Data Center monitoring for the adequate operation of manufacturing servers and related equipment.
• Approve Validation Master Plan, Periodic Reviews and System Audit Trails that are generated for the computerized systems.
• Responsible for the management of the Systems Vault to ensure compliance with procedures.
• Establish and monitor KPI’s for the Systems Engineering group. IV.

Requirements:

• Education: Bachelor Degree in Engineering
• Master’s Degree preferred.

Experience:

• Eight to ten years of experience in automated / control systems in the pharmaceutical industry.
• Knowledge, Skills and Abilities: excellent verbal, writing and technical writing skills in both languages.
• Ability to interpret and apply current Good Manufacturing Practices. Mathematics skills and analytical ability.
• Knowledge in client /server architecture and connectivity concepts. Knowledge in computer system validation.
• Basic computer knowledge (Microsoft Office software - Excel, PowerPoint, Word).
• Must be able to make decisions based on available facts while meeting established deadlines and priorities.
• Demonstrated leadership.
• Well versed in the latest quality assurance techniques.
• Able to work with minimum supervision and under pressure.
• Takes initiative and makes good judgment in the performance of duties.
• Ability to communicate effectively with personnel.