Senior Technical Lead

1 week ago

Indianapolis, Indiana, United States Lannett Company Full time
Senior Engineer Job Summary

The Senior Engineer plays a critical role in ensuring the efficient and effective use of our manufacturing and facilities equipment. This includes participation and direction of site Master Planning, as well as management of capital projects and associated activities.

Key Responsibilities:
  • Support Departmental Plans and Programs: Contribute to the development of plans and programs that align with the company's yearly and long-term objectives, including site Master Planning.
  • Future-Planning and Contingency Development: Develop and maintain future-plans and contingencies for construction and renovation projects.
  • Financial Planning and Budgeting: Assist in financial planning and budgeting for capital projects, ensuring alignment with company objectives.
  • Capital Project Execution: Execute capital project work as prescribed by the capital budget, ensuring timely and within-budget completion.
  • ROI and Cost Justification: Generate return on investment (ROI) and cost justification reports for ongoing systems upgrades and replacements.
  • Expense Budget Management: Support the department's expense budget, identifying and implementing cost savings plans and opportunities.
  • Budget Management for Capital Projects: Maintain budgets for assigned capital project work up to $1.5MM.
  • Contractor and Vendor Management: Supervise outside contractors and vendor OEMs for equipment installation, start-up, repair, and routine preventative maintenance.
  • Engineering, Safety, and Compliance Systems: Implement and manage engineering, safety, and compliance systems, including design and validation plans.
  • PLC and Instrumentation Expertise: Demonstrate understanding and interpretation of PLC and instrumentation issues.
  • Mentorship and SME: Mentor engineering technicians and department engineering staff, serving as a subject matter expert in multiple process and facility functional areas.
  • Site Equipment and Facility Drawings: Maintain site equipment and facility drawings, including reading and optimizing PID, arch, and MEP drawings.
  • Equipment Qualification Protocols and Training: Oversee development of equipment qualification protocols and training documents, maintaining and creating detailed specifications.
  • Quality Management System: Manage and document changes to equipment, project activities, and address CAPAs and Deviations within the site Quality Management System.

Requirements:

  • Bachelor's Degree: Required.
  • Engineering Experience: Ten years of engineering experience in the pharmaceutical manufacturing arena, with detailed knowledge of pharmaceutical mfg. equipment and facility systems desirable.
  • cGMP and Regulatory Knowledge: Solid understanding of cGMPs and other regulatory requirements.
  • Technical Expertise: Excellent technical (engineering) working knowledge across all pharmaceutical mfg. equipment types and in HVAC and utility areas.
  • Validation and Project Management: Strong working knowledge and experience with validation practices and project management.
  • Project Management and Prioritization: Ability to handle multiple projects and assignments with varying priorities in a manner that meets the company's goals.
  • Process Optimization: Capable of optimizing processes in respect to financial efficiency, system performance, or both.
  • Work Environment: Traditional office environment with frequent walking to other areas of the facility and exposure to outside elements; able to stand for long periods of time occasionally based on job demands.
  • Travel: Occasional business travel up to 3 weeks per year.

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