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Lead Automation Engineer

2 months ago

lititz, United States Apex Systems Full time

Apex Systems is partnering with our client, a leader in the Consumer Health Products space. We are looking for an Automation Engineering Team Lead. This position will sit in Lititz, PA. It is a contract-to-hire role, with expectation to convert permanent after 6-12 months. There is flexibility for a hybrid work schedule but it will need to be onsite multiple days a week in Lititz.


Summary:

The Automation Engineering Lead 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:

  • Ensures quality and compliance in all actions.
  • 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.
  • Comply with the requirements established in the Environmental Health and Safety (EHS) Program and the ISO 14001 Standard
  • 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 associated departments
  • 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 permits and ensuring compliance with applicable regulations.

Selecting contractors.

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.


Requirements:

  • Bachelor Degree in Engineering, Master’s Degree preferred.
  • Six or more years of experience in automated / control systems in the pharmaceutical industry.
  • PMP preferred