Senior cGMP Manufacturing Consultant

Senior cGMP Manufacturing Consultant
 
PharmEng Technology is actively seeking a Senior cGMP Manufacturing Consultant to assist our team for open projects located in  Swiftwater, PA


Job Description:
  • Delivery of quality products within agreed upon time and budget targets.
  • Planning and development of staff needed to meet company manufacturing goals and support of company’s communication and culture objectives.
  • Identify and direct key activities so that approved products are manufactured and released on schedule, within quality standards and budget objectives, per plan.
  • Oversee and direct all particle manufacturing related functions and activities (raw material good receipts, consumable receipt, material movement, inventory, SAP transactions, manufacturing, etc.).
  • Develop and ensure updated back up plans exist to meet production targets during equipment downtime or vendor caused issues Oversight.
  • Oversee and coordinate various programs essential to manufacturing procedures (e.g., hiring of staff, training, scheduling, safety, housekeeping, cost reduction, budgeting, employee involvement, corrective action, etc.).
  • Work with client Engineering and Production leadership to identify improvements in manufacturing equipment/process to improve productivity and quality of current and future products while expecting cost reductions.
  • Workflow/Procedure Improvement
  • Establish workflow and procedures that enhance speed and efficiency without compromising product safety or integrity.
  • Supervise and provide direction to staff for current performance and career growth.
  • Determine and execute programs for development/training/succession planning for all staff.
  • Ensure area and personnel MBOs, budgets, KPIs, manning levels, and other business monitoring tools are developed and achieved on an annual basis.
  • Attend and participate on product development teams for new products and processes that will require manufacturing time and manufacturing resources.
  • Plan, budget, and implement initiatives for manufacturing of new products or with new processes.
  • Ensure all areas of responsibility (personnel and functional area) are audit ready. Site SME for particle manufacturing related audit issues.
  • Assist company officers and senior staff members in the development and formulation of long and short-range planning, policies, programs, and objectives.
  • Guide and/or develop processes under area of responsibility that provide and improve short-term and long-term sustainability.
  • Writing and/or review of test plans/reports, directing local contractors and service providers, interaction with federal, state and local authorities, etc.
 
 Job Requirements:
  • Minimum Bachelor’s Degree, preferably in Science or Engineering, or related discipline
  • 15+ years Sterile Manufacturing Management experience
  • Requires 10 (or more) years of experience working in the pharmaceutical manufacturing industry specifically with production quality and/or supply chain focus
  • Experience in qualification/validation of production suites
  • Strong understanding of analytics and its applicability to the Manufacturing Industry challenges
  • 10-15 years of experience managing a production team in a FDA regulated manufacturing environment (10+ years).
  • Strong understanding of cGMPs, and their application within a FDA governed manufacturing environment
  • Working knowledge of FDA, OSHA, ISO, and other bodies regulating requirements for manufacturing, production, and warehouse areas.
  • Demonstrated personnel management and/or proven record of project leadership and management skills; adherence to KPIs
  • Strong technical skills to fully understand and solve manufacturing related issues that occur in daily activities and projects/programs.
  • Demonstrated aptitude and ability to successfully manage production plans while meeting scheduled program/project deadlines
  • Works well as a member of a group Leader
  • Capable of working with multiple site teams.


Thank you for your consideration and application!  We review all resumes and submissions, however, due to the sheer volume of requests that we receive, only successful candidates will be contacte
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