This position will be in charge of leading the execution of equipment qualifications, test method validation and process validation changes for new product development.
A self-motivated engineer with attention to detail and strong organizational and collaboration skills will be best suited to this role.
This person will be working closely with process experts to create documentation and move it through the change order process.
Critical thinking will be important to make sure the data is appropriately documented and able to be used to support validation efforts.
Education Required: Bachelor's Degree.
Years' Experience Required: 4 Yrs Minimum.
HM's Top Needs:
Ability to lead their own work, think critically, and communicate clearly.
TMV and IQ/OQ/PQ Experience.
Previous work leading change orders, preferably in Agile, but other systems are also acceptable.
Responsibilities:
Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products.
Integrates equipment and material capabilities to meet process module target specifications and technology target specifications.
Reviews product development requirements for compatibility with processing methods to determine costs and schedules.
Interacts with product design and development personnel to ensure that processes and designs are compatible.
May develop and conduct statistical analysis or recommend additions to document work.
Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations.
This can include scouting and feasibility work, material selection, process and equipment selection, tooling / fixture and equipment installation and assessment of inputs, outputs and alignment to requirements.
Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems.
Ensures processes and procedures are in compliance with regulations.