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Lead Manufacturing Coordinator

2 months ago

Chicago, Illinois, United States Sterling Engineering Full time

Position Overview:

As a key leader in our Fill Finish and Visual Inspection departments, you will play a vital role in managing our production operations. Your primary focus will be on ensuring the delivery of top-notch products that comply with all regulatory standards while supporting our strategic objectives.

Key Responsibilities:

  • Direct and oversee a production team, optimizing the use of machinery and materials to manufacture quality products in accordance with cGMP regulations.
  • Mentor and guide team members, providing constructive performance evaluations and fostering professional growth.
  • Ensure a safe working environment by adhering to company policies, environmental health and safety (EHS) standards, and relevant regulatory frameworks (cGMP, ISO 6, ISO 7, ISO 8).
  • Conduct training sessions for team members on equipment usage, operational processes, and Standard Operating Procedures (SOPs).
  • Manage packaging timelines, departmental budgets, and engage in project implementation.
  • Investigate production issues, identify root causes, and recommend enhancements for operational efficiency.
  • Participate in cross-functional project teams as required.
  • Contribute to ongoing improvements by reviewing and revising SOPs and related documentation.
  • Utilize data analysis tools to support reporting requirements and decision-making.
  • Oversee the final review of documentation to ensure compliance and establish clear deadlines.
  • Collaborate with team members to facilitate seamless product flow and share effective practices.

Candidate Profile:

The ideal candidate will possess a Bachelor's degree in Engineering, Pharmaceutical Sciences, or a related life science discipline, with a minimum of 5 years of relevant experience (or a Master's degree with at least 2 years of experience). Prior supervisory experience in aseptic processing is highly desirable.

Additional qualifications include:

  • Experience with manual visual inspection of pre-filled syringes and finished product packaging, preferably with serialization.
  • Thorough understanding of FDA cGMP regulations.
  • Exceptional communication, leadership, and analytical skills.
  • Strong technical writing abilities, with experience in developing SOPs and handling deviations.
  • Proven track record of leading and inspiring operational teams.
  • Ability to work collaboratively in a cross-functional environment.
  • Proficiency in MS Office applications.
  • A commitment to leadership and the professional development of team members.
  • Familiarity with current CFRs and a solid grasp of cGMP principles.