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Automation Engineering Team Supervisor

2 months ago

Lititz, Pennsylvania, United States Apex Systems Full time

Apex Systems is collaborating with a prominent player in the Consumer Health Products sector to find an Automation Engineering Team Supervisor. This role is designed for an individual who will lead the Automation Engineering efforts within the organization.

Position Overview:

The Automation Engineering Supervisor will offer Technical Leadership to the Systems Engineering division. This role encompasses the management of business and manufacturing systems along with their associated infrastructure. Key responsibilities include the planning, execution, and support of manufacturing, administrative, packaging, facilities, utilities, and laboratory systems technologies.

Key Responsibilities:

  • Ensure adherence to quality and compliance in all operations.
  • Participate in GMP training sessions as scheduled.
  • Maintain strict compliance with established procedures relevant to the position.
  • Demonstrate the highest level of integrity in all tasks.
  • Promptly identify, report, and rectify any deviations observed in the workplace.
  • Foster a culture of employee engagement and commitment to excellence.
  • Comply with the Environmental Health and Safety (EHS) Program and ISO 14001 standards.
  • Support organizational operations through effective and economical use of information technology across various departments.
  • Develop and implement strategic and tactical business plans aimed at continuous improvement in information technology utilization.
  • Oversee the preparation, administration, and management of the Systems Engineering budget.
  • Provide Systems Engineering and technical assistance to all relevant departments.
  • Manage the creation and review of departmental standard operating procedures (SOPs) and work instructions to align with company requirements.
  • Stay informed about advancements in computing technology, manufacturing automation, and communication systems related to regulatory compliance.
  • Assess and recommend new technological solutions to enhance operational efficiency and regulatory adherence.
  • Lead the development and execution of a framework for Computerized Systems Validation (CSV) in accordance with Good Manufacturing Practices (cGMPs).
  • Oversee projects to ensure successful and timely completion.
  • Recruit, hire, evaluate, supervise, and, when necessary, discipline team members.
  • Encourage the professional growth of team members to maximize their potential and align their efforts with company objectives.
  • Supervise project work involving the planning, execution, validation, and support of computerized systems that support plant operations.
  • Ensure all aspects of assigned engineering projects are managed effectively, including:

Assessment of new systems and equipment.

Preparation of justifications and funding requests.

Conducting financial analyses.

Managing external engineers and consultants.

Identifying and preparing necessary permits while ensuring regulatory compliance.

Selecting contractors and coordinating project activities.

Ensuring the completion and approval of project documentation, including qualification and validation protocols.

Controlling capital and expense fund expenditures within the approved budget.

Providing training on process and equipment operation.

Following up to ensure project objectives are achieved.

  • Deliver technical support to various technical areas.
  • Prepare reports for management presentations and communicate findings as required.
  • Review and approve all computer validation documents within the organization.
  • Monitor the Data Center to ensure optimal operation of manufacturing servers and related equipment.
  • Approve Validation Master Plans, Periodic Reviews, and System Audit Trails for computerized systems.
  • Manage the Systems Vault to ensure compliance with established procedures.
  • Establish and monitor Key Performance Indicators (KPIs) for the Systems Engineering team.

Qualifications:

  • Bachelor's Degree in Engineering; a Master's Degree is preferred.
  • A minimum of six years of experience in automated/control systems within the pharmaceutical industry.
  • Project Management Professional (PMP) certification is preferred.