57 East Willow Street Millburn NJ USA 07041 Millburn, NJ 07041 US
This is a high visibility and demanding role, bringing with it the opportunity to learn about the company, shape global healthcare trends and have impact at the highest level.
Major accountabilities: Responsibilities include but not are limited to: Execute and/or review deliverables for the Site Remediation Project Plan, enabling overall strategic implementation of remediation activities according to the sites commitments to Health Authorities. Remediation activities are related to facility, equipment, quality systems, computerized systems, laboratory or products. Work in close collaboration with site-based SMEs to ensure the implementation of robust, high-quality deliverables, with clear alignment between inspection SMEs and site leadership. Provide engineering, validation and maintenance support to the commissioning and qualification (C&Q) of production and QC equipment, facility and utilities; help define and optimize equipment qualification strategy according to global standards Author relevant plans, protocols, summary reports and periodic reviews; own C&Q activities for remediation Authors and reviews project documentation, as needed. (URS, FRS, Technical and Functional Specifications) Manage calibration and PM of equipment including onsite support by vendors, as related to remediation activities. Work closely with Site Project Management to coordinate vendor on site support Define and plan agendas, deliver content and/or lead preparation for project governance meetings, as delegated by the Site Remediation Lead Responsible for routine reporting of the status of deliverables and risk to the Site Remediation Lead and delivering relevant content for governance meetings Reinforce the sites Inspection Readiness program for internal and external inspections Actively drive high quality deliverables at the site by promoting a high standard of Quality Culture. Helps build and drive a culture of compliance throughout the organization Inspire change management initiatives, control project scope to limit schedule changes, and capture changes of scope that may arise Partner with Site Engineering to ensure the Primary SME is trained and ready to deliver remediation evidence during regulatory inspections; final project handover, including Remediation Continuity Plan as needed
Key performance indicators:
- Successful and timely completion of the sites Remediation Plan deliverables, meeting strategic objectives of AAA Global Remediation Task Force
- Successful Health Authority Inspections
- Financial responsibility: (Budget, cost, sales, etc.) Adhere to established budget and costs
- Impact on the organization:
- High; significantly contributes to success of AAA RLT objectives by ensuring cGMP-Compliance with focus on Successful Health Authority Inspections & correct, cGMP compliant decisions as part of critical Quality Issues (e.g. market actions).
- B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field or related field with 5 years relevant experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations
- Ability to read/interpret engineering drawings and design documents
- Excellent technical writing and verbal communication skills
- Working knowledge of FDA regulations and GMP systems, particularly 21 CFR part 11, 210, 211; and experience providing engineering support in a highly regulated or pharmaceutical / biotech facility.
- Strong understanding and operating awareness of working in a pharmaceutical company. Experience in regulatory agency and partner/collaborator inspections
- Demonstrated ability to problem solve and mediate complex issues. Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere
- Strong communication, leadership and team working skills. Project management capabilities preferred
- Effective in prioritizing, shows the appropriate sense of urgency around prioritized tasks. Flexibility and ability to prioritize and manage multiple tasks simultaneously
- Creative thinker in ways in which we can ensure better compliance and systems (A risk-based approach to Quality and Compliance)
- Demonstrated excellence in written and verbal communication. Ability to effectively communicate at all levels in the organization - oral and written
- Demonstrated ability to work cross-functionally
- Highly motivated, driven and have a passion to be part of a fast-paced team
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.