Manufacturing Engineer

Job Title:                    Manufacturing Engineer

Department:               Engineering

Reports To:                TBD

Pay Classification:    Exempt

Position Summary:   The Manufacturing Engineering is responsible for managing and leading a broad set of Engineer, Trouble shooting, Tech Transfer, Validation and other Engineering activities. This includes technically supporting the IVD device manufacturing operation.  The Manufacturing Engineer works to support the transfer of new products into manufacturing and also provides support for continuous process improvement (CPI) for daily production operations.

Duties & Responsibilities include but are not limited to:

  • Provide daily floor support of an assigned business unit manufacturing line for real time resolution of issues and observations for CPI new initiatives
  • Analysis and reporting to management of Statistical Process Control (SPC) data from production operations in real time
  • Perform various engineering studies including DOEs, time studies and technical feasibility of new manufacturing process changes.
  • Preparation of Engineering Change Order (ECO) packages including BOM updates, standard operational procedure (SOP) updates, drawing updates, raw material specifications and batch records.
  • Completion of CAPA projects as assigned by supervisor
  • Manage collateral duties as assigned by Eng. Manager (examples: equipment calibrations or departmental training matrix updates)
  • Work with manufacturing operations to develop standards for existing and new products
  • Design of new tools and fixtures to improve manufacturing efficiency
  • Support IQ/OQ/PQ of new equipment and process transfers to manufacturing including writing of protocols and final reports
  • Manage outside vendor engineering projects as assigned by Engineering Manager such as new or upgraded existing mold tooling qualifications and contract manufacturing activities
  • Manage activities associated with 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 Engineering Team, 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.
  • 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.

Qualifications Required:

Education/Work Experience/Knowledge:

  • B.S. in Mechanical, Electrical, Chemical or Industrial Engineering.
  • Minimum 3-5 years’ experience working in a regulated manufacturing environment; Understanding of FDA and ISO regulations.
  • Strong knowledge of GMP, SOPs and quality systems.
  • Experience conducting equipment and process qualifications (IQ/OQ/PQ).
  • Demonstrated problem-solving and troubleshooting skills, including root cause analysis
  • Experience in completing assigned CAPAs, and Root Cause Investigations.
  • Green belt certification or experience utilizing Quality Engineering and Process Excellence tools is preferred. Advanced Quality tools include Risk Assessment, Failure Modes Effect Analysis (FMEA), SPC, Root Cause Analysis, Design of Experiments (DOE), Mistake Proofing / Poke Yoke, etc.
  • Demonstrated ability to effectively work cross functionally with other departments including R&D, Manufacturing, and QA/QC.
  • Excellent Interpersonal and communication skills
  • 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.
  • Strong technical team development skills and experience
  • 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.

For immediate consideration, please send a resume to 

Chembio is an Equal Opportunity Employer.