Process & Validation Engineer ll*Hybrid Schedule (must be from Biopharma or Cleanrooms environment)

Biotechnology Boston, Massachusetts United States


Primary Responsibilities

· Responsible for analyzing production and supporting other areas as needed, identifying problems, developing countermeasures and implementation.

· Manages data through data collection, data modeling, data analysis, cost/benefit analysis, process mapping and/or problem analysis.

· Conduct risk assessments such as PFMEA, FMEA, 5WHYs, etc.

· Assist development and execute validation protocols for new and in use equipment and processes.

· Systematically interacts with process owners and users to obtain feedback and to verify performance.

· Manages the optimization of resources and processes in compliance with company policies/procedures.

· Writes SOPs and training documents to establish standard work and develops initial documents for new processes and systems.

· Troubleshoot equipment and hardware issues, as required.

· Performs other duties as assigned.

Required Experience (One+ Year - education will be considered)

· Experience in regulated environments (FDA or ISO 9001 preferred)

· Experience in GMP Manufacturing environments.

· Direct applicable experience

· Project management

· MS Office Suite

Preferred Experience (Two+ Years)

· Biopharma manufacturing processes, Cleanroom experience

· Advanced software application skills (IE. Access / Visio / Minitab)

· Knowledge of Lean Manufacturing practices and the Toyota Production System (TPS).(TPMS).

· Knowledge of Six Sigma process improvement methods (Green Belt preferred)

Minimum Education

· Bachelor's degree in Industrial Engineering, Chemical Engineering, Mechanical Engineering or related


The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment ranges with typical noise level equivalent to office functions but exposed to warehouse traffic and fork truck noises. Work is primarily conducted in office spaces, clean rooms, or warehouses. Exposure to non-climate-controlled environments is expected. Employees are provided with information about workplace safety and health issues and receive periodic safety training. The training covered potential safety and health hazards. All employees are expected to maintain a safe work environment, obey safety rules and exercise caution in all work activities.

DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.