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Company Contact Info
3661 Horseblock Road
Medford, NY 11763
- Susan Norcott
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Senior Manager, Manufacturing Engineering
Chembio Diagnostic Systems Inc. • Medford, NY
Posted 13 days ago
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We Improve Lives—that’s what drives us. It’s what makes us better, more innovative, more compelled to work harder. What we do is develop superior point-of-care rapid testing solutions for healthcare providers around the world; what we help create is healthier lives and communities.
Chembio Diagnostic Systems, Inc. is seeking a motivated Senior Manager, Manufacturing Engineering to join our fast paced Engineering Department.
Position Summary: The Senior Manager, Manufacturing Engineering is responsible for managing and leading a broad set of Automation, Tech Transfer, Validation and other Engineering activities.
Duties & Responsibilities include but are not limited to:
- Manage activities associated with Automation, Qualification and Validation efforts for New Products and Processes, Equipment, Systems, and Facilities. This includes new product transfer into Manufacturing, scale up activities, process validation, equipment qualification, and computer systems validation.
- Manage transfer activities from R&D and/or Manufacturing to Chembio OEM partners, as well as contract manufacturing organizations (CMOs). This includes training to external partners in the manufacture of Chembio technology to established procedures and specifications.
- Manage the facility, utility, system and equipment cleaning and other validation activities for the site and manage validation projects from initiation through to completion. The position is expected to have a solid understanding of industry standards, engineering design and validation compliance requirements and is required to supply support/technical knowledge for the development/refinement and implementation of validation standards.
- Technically independent and maintains up-to-date knowledge of engineering and validation standards and regulatory compliance requirements and contributes to the development of new validation standards.
- Under the guidance of the COO, manage the Master Validation Project list based on priorities, allocating resources to projects, managing timelines for projects, budgets and developing the teams. Establishes priorities and long range project plans with consultation with supervisor.
- Assists with facility inspections, FDA/EU inspections, internal audits, and startup activities.
- Contributes validation input and represents the Validation / Tech Ops function on cross-functional teams. Manage compliance of validation activities with other departments to meet established validation policies and procedures, cGMP requirements, and industry standards.
- Provide technical oversight and participate and/or lead troubleshooting efforts related to manufacturing equipment and processes.
- Review and approve nonconformances and product / process changes in compliance with Chembio’s policy for change control, nonconformance handling, and risk management.
- Lead equipment procurement process by authoring URS, DQ, and executing FAT and SAT.
- Generate risk documentation such a pFMEA.
- Participate and manage continuous process improvement and lean manufacturing initiatives.
- B.S. Degree in a Scientific or Engineering discipline, such as Chemical or Mechanical Engineering, Chemistry, Biochemistry, Microbiology preferred.
- Minimum of 5-10 years of experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.
- Strong knowledge of GMP, SOPs and quality systems.
- Experience with FDA (or Notified Body) inspections.
- Comprehensive understanding of qualification or validation protocols, with ability to develop new more robust risk based qualification approaches for risk reduction.
- A solid understanding of industry standards, engineering design and validation compliance requirements.
- Skilled in the use of statistical techniques to analyze data.
- Ability to work on multiple assignments in collaboration with various departments.
- Good project and personnel management skills.
- Ability to communicate and work independently with scientific/technical personnel.
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
- Excellent writing and editing skills.
- Advanced Skills with MS Office applications Word, Excel, Access, as well as Adobe Acrobat.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
Full benefit package including:
401(k) with company match
Company outings and much more!
Chembio Diagnostic Systems, Inc. is a public company serving the increasing global demand for rapid tests needed for the effective prevention and treatment of infectious diseases and other conditions.
Located minutes off the Long Island Expressway in Medford, NY, Chembio operates a research and manufacturing facility that is registered with the US FDA.
For immediate consideration, please send a resume and salary requirements. Chembio is an Equal Opportunity Employer.
For more information about Chembio Diagnostic Systems Inc., please visit our website at www.chembio.com