Overview
Part Time
Accepts corp to corp applications
Contract - W2
Contract - Independent
Contract - 20 day((s))
Skills
Process Engineer
Job Details
Sr Process Engineer
Hybrid (East Coast Travel Req)
Phone + Skype
Job description:
Hybrid (East Coast Travel Req)
Phone + Skype
Job description:
This role will be traveling to various sites, with some overseas travel required.
This role is responsible for providing technical support regarding the execution of 4 Process Performance Qualifications (PPQ) by visiting the tech transfer receiving sites and evaluating the current state of operational readiness through the execution of pFMEA for each site.
General Process Engineering Responsibilities:
Develop and execute current state operational readiness assessment pFMEAs
Report findings with recommendations and escalate critical risks/gaps identified timely
Support resolution of identified gaps, identifying root causes and defining corrective/preventive actions with equipment, processes and automated systems
Possess demonstrated technical skills and knowledge with biopharmaceutical operations specifically Monoclonal Antibody (Manufacturing)
Possess understanding of engineering drawings, SOPs, vendor documentation, and other technical documentation
Efficiently and effectively manage assigned projects and initiatives
As required by group, assist Senior and Principle Engineers on more complex projects/initiatives
Requirements:
Support resolution of identified gaps, identifying root causes and defining corrective/preventive actions with equipment, processes and automated systems
Possess demonstrated technical skills and knowledge with biopharmaceutical operations specifically Monoclonal Antibody (Manufacturing)
Possess understanding of engineering drawings, SOPs, vendor documentation, and other technical documentation
Efficiently and effectively manage assigned projects and initiatives
As required by group, assist Senior and Principle Engineers on more complex projects/initiatives
Requirements:
Bachelor's degree in engineering or equivalent field
6 to 10 years or role specific experience required
Advanced experience executing pFMEAs, PPQs and assessing and reporting on the current state of Operational Readiness.
Ability to assess and report on process validation activities involving cross-functional teams including Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others
Comfortable walking through all areas of the production module (CNC space, ISO classified rooms, grey space).Knowledge of the product flow through the various production areas.
Strong Understanding of process fundamentals and qualification/validation requirements for the following:
o Small molecule chemical synthesis
Advanced experience executing pFMEAs, PPQs and assessing and reporting on the current state of Operational Readiness.
Ability to assess and report on process validation activities involving cross-functional teams including Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others
Comfortable walking through all areas of the production module (CNC space, ISO classified rooms, grey space).Knowledge of the product flow through the various production areas.
Strong Understanding of process fundamentals and qualification/validation requirements for the following:
o Small molecule chemical synthesis
Monoclonal antibody or protein biomanufacturing
Cell therapy and regenerative medicine
Sterile drug product fill/finish
Analytical QC laboratories
Computer System
Packaging
Ability to interact directly and communicate concisely with senior management
Advanced Microsoft Project capabilities.
Familiar with regulatory audit process and capable of assessing provided supporting documents
Proficient in computer skills and MS Office applications.
Cell therapy and regenerative medicine
Sterile drug product fill/finish
Analytical QC laboratories
Computer System
Packaging
Ability to interact directly and communicate concisely with senior management
Advanced Microsoft Project capabilities.
Familiar with regulatory audit process and capable of assessing provided supporting documents
Proficient in computer skills and MS Office applications.
("Believe you can and you're halfway there.")
Theodore Roosevelt
Yogesh Sharma | Lead Tech Recruiter
E:
P: +1 |
Job description :
Location Marysville, OHIO
Key Responsibilities:
Develop and modify Yaskawa robot programs based on project specs.
Diagnose and troubleshoot robotic issues.
Collaborate with engineering and production for system integration.
Perform system testing and validation.
Provide technical support and training to team members.
Maintain documentation for robotic systems and programming changes.Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.