Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
true
Engineer
Posted: 09/03/2024
2024-09-03
2024-10-12
Employment Type:
Contract
Job Category: Engineering
Job Number: 614222
Is job remote?: No
Country: United States
Job Description
Target PR Range: 29-39/hr
*Depending on experience
The Engineer, in Physical Methods, is responsible for engineering activities required for the development /
qualification / validation and transfer of physical GMP test methods for combination products, devices,
primary containers, and secondary packaging parts. The Engineer shall have the ability to work on
multiple projects at one time that may involve changes or new product, processes, tooling or equipment
introduction to improve quality and reliability and reduce cost. Phases of projects include: developing
combination product test methods, providing key experienced support for qualification, validation, transfer,
and life cycle support of methods for manufacturing, new product introduction, training, and production
support.
Responsibilities:
• Develop, qualify, and validate GMP physical test methods for vials, prefilled syringes, and
injection devices.
• Work in teams to transfer new combination product test method and assembly
requirements to manufacturing, by developing six sigma processes and compiling
documentation for manufacturing assembly requirements.
• Develop, qualify, validate, and transfer new equipment, software, systems, and methods.
• Implement projects per Final Product Technologies and company procedures to ensure
projects are completed on schedule and within established budget.
• Provide experienced support for investigations as well as new process development
required to improve manufacturing operations.
• Coordinate test method development and delivery with selected contractors.
• Ensure that qualification parameters are met for product assembly requirements.
• Support development of cost estimates for new processes, gauges and equipment
development used in generation of capital request documentation.
• Generate procedures necessary to support department and new process equipment.
• Provide experienced training to individuals in the operation and maintenance of processes,
test methods and equipment introduced to Quality Control and/or the manufacturing
department (i.e. production operator, mechanics, process engineers).
• Participate in and assume responsibilities of team functions as assigned (i.e. Product
Improvement Teams).
• Generate/author and be responsible for the Test Method documents.
Gather test method requirements that result in equipment that operates safely and
considers ergonomic factors in the design
• Perform other duties as required by the Group Manager
• Align with the requirements, responsibilities, and authority as required
• Maintains integrated timelines collecting appropriate multi-functional details and work which
are aligned with the functional and project work
• Networks internally to ensure alignment, commitment to project objectives and timelines as
well as to ensure effective execution of projects
• Networks with manufacturing, quality and regulatory organizations both internal and external
• Drives the multi-functional communication and integration of information to optimize
decision making, issue resolution and change management throughout project lifecycle
• Excellent verbal and written communication skills are applied to communicate project
status and risks associated with integrated timelines to leadership
• Collaborates with other functional leaders to ensure project success, momentum and
commitment
• Proactively identifies issues and/or risks and develops mitigation options to resolve or
increase efficiently
• Integrates partner/vendor timelines with timelines as appropriate
Preferred Qualifications
• M.S. in Mechanical Engineer, Chemical or Biomedical Engineering, or Chemistry
• Excellent written and verbal communication skills
• Ability to work in a highly matrixed team environment
• 2 years of experience in the biotechnology/pharmaceutical industry
• 2 years of experience in equipment, method, and mechanical design
• Technical writing experience
• Experience with SolidWorks (or other 3D-CAD software)
• Experience with combination products and regulatory requirements
• Experience applying Minitab (or other statistical software packages)
*Depending on experience
The Engineer, in Physical Methods, is responsible for engineering activities required for the development /
qualification / validation and transfer of physical GMP test methods for combination products, devices,
primary containers, and secondary packaging parts. The Engineer shall have the ability to work on
multiple projects at one time that may involve changes or new product, processes, tooling or equipment
introduction to improve quality and reliability and reduce cost. Phases of projects include: developing
combination product test methods, providing key experienced support for qualification, validation, transfer,
and life cycle support of methods for manufacturing, new product introduction, training, and production
support.
Responsibilities:
• Develop, qualify, and validate GMP physical test methods for vials, prefilled syringes, and
injection devices.
• Work in teams to transfer new combination product test method and assembly
requirements to manufacturing, by developing six sigma processes and compiling
documentation for manufacturing assembly requirements.
• Develop, qualify, validate, and transfer new equipment, software, systems, and methods.
• Implement projects per Final Product Technologies and company procedures to ensure
projects are completed on schedule and within established budget.
• Provide experienced support for investigations as well as new process development
required to improve manufacturing operations.
• Coordinate test method development and delivery with selected contractors.
• Ensure that qualification parameters are met for product assembly requirements.
• Support development of cost estimates for new processes, gauges and equipment
development used in generation of capital request documentation.
• Generate procedures necessary to support department and new process equipment.
• Provide experienced training to individuals in the operation and maintenance of processes,
test methods and equipment introduced to Quality Control and/or the manufacturing
department (i.e. production operator, mechanics, process engineers).
• Participate in and assume responsibilities of team functions as assigned (i.e. Product
Improvement Teams).
• Generate/author and be responsible for the Test Method documents.
Gather test method requirements that result in equipment that operates safely and
considers ergonomic factors in the design
• Perform other duties as required by the Group Manager
• Align with the requirements, responsibilities, and authority as required
• Maintains integrated timelines collecting appropriate multi-functional details and work which
are aligned with the functional and project work
• Networks internally to ensure alignment, commitment to project objectives and timelines as
well as to ensure effective execution of projects
• Networks with manufacturing, quality and regulatory organizations both internal and external
• Drives the multi-functional communication and integration of information to optimize
decision making, issue resolution and change management throughout project lifecycle
• Excellent verbal and written communication skills are applied to communicate project
status and risks associated with integrated timelines to leadership
• Collaborates with other functional leaders to ensure project success, momentum and
commitment
• Proactively identifies issues and/or risks and develops mitigation options to resolve or
increase efficiently
• Integrates partner/vendor timelines with timelines as appropriate
Preferred Qualifications
• M.S. in Mechanical Engineer, Chemical or Biomedical Engineering, or Chemistry
• Excellent written and verbal communication skills
• Ability to work in a highly matrixed team environment
• 2 years of experience in the biotechnology/pharmaceutical industry
• 2 years of experience in equipment, method, and mechanical design
• Technical writing experience
• Experience with SolidWorks (or other 3D-CAD software)
• Experience with combination products and regulatory requirements
• Experience applying Minitab (or other statistical software packages)
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