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Senior Automation Operations Leader

2 months ago

Petersburg, United States Civica Full time
Job Title: Associate Director AutomationCompany: Civica

Key Responsibilities:

  • Formulate and implement the automation framework for the organization.
  • Oversee the Automation Engineering team, ensuring the integrity of critical automation systems in the production of both commercial and clinical products.
  • Responsible for the operational systems that facilitate site commissioning, validation, safety, compliance, and quality assurance in manufacturing.
  • Lead and mentor a team of automation engineers, fostering collaboration with departments such as IT, Quality, Validation, Manufacturing, Engineering, and Technical Services.
  • Provide strategic guidance and support to Manufacturing and Operations, addressing challenges and ensuring effective solutions.
  • Set strategic priorities for the technological landscape, including the management of new facilities and validation lifecycle strategies.
  • Build and nurture a high-performing team that promotes a culture of innovation, quality, compliance, and accountability.
  • Ensure readiness for inspections and audits while adhering to cybersecurity protocols.
  • Guide, coach, and assess automation engineers to enhance their skills and performance.
  • Establish automation policies in line with industry regulations and standards.
  • Supervise the creation and review of Standard Operating Procedures (SOPs) and system support documentation.
  • Examine operational process challenges and propose corrective measures.
  • Collaborate with cross-functional teams and external vendors to advance automation objectives.
  • Initiate and sustain continuous improvement initiatives.
  • Act as a Subject Matter Expert during regulatory inspections.
  • Exhibit strong leadership, motivation, and team-building capabilities.
  • Manage departmental budgets and allocate resources judiciously.
  • Promote a culture of continuous improvement and best practices, prioritizing safety.

Basic Qualifications:

  • Bachelor's degree or equivalent technical qualification is required.
  • Over 10 years of experience in automation within the pharmaceutical sector.
  • At least 5 years of experience in automation execution.
  • Proficient in developing software test plans, user requirements, and system design documentation.
  • Strong expertise in programming and troubleshooting Rockwell or Siemens PLCs.
  • In-depth knowledge of compliance regulations and standards.
  • Experience in various phases of engineering projects, from design through to commissioning and ongoing improvement.
  • Ability to collaborate across departments to devise solutions that align with business objectives.
  • Exceptional planning, organizational, project management, and time management skills.
  • Excellent verbal and written communication abilities.

Preferred Qualifications:

  • Familiarity with Database/Historian technologies (SQL, AVEVA PI).
  • Understanding of virtualization technologies and basic networking.
  • Experience with Allen Bradley PLC platforms, SCADA systems, and Industrial Ethernet networks.
  • Knowledge of Data Integrity principles in the Biotech sector and experience with regulatory inspections.
  • Experience in managing and delivering large-scale capital projects.
  • Expertise in Computerized Systems Validation (CSV) and methodologies for continuous improvement.