Process Engineer / Validation Engineer

Responsibilities may include the following and other duties may be assigned. Provides technical and engineering support in a manufacturing area. 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. 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.  Deep knowledge of the validation lifecycle.  TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills. DIFFERENTIATING FACTORS Autonomy: Entry-level individual contributor on a project or work team. Works with close supervision. Organizational Impact: Delivers work of complex projects or related activities. Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident. Makes minor changes in systems and processes to solve problems. Communication and Influence: Communicates with internal and external contacts.  Contacts others to gather, confirm and convey information. Leadership and Talent Management: N / A – job at this level is focused on self-development. Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education. Requires a Baccalaureate degree in Engineering (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A),

This position is needed to work with two new products for the Ponce site.  Experience in validations is a must.  Resource must be fully bilingual, must be capable of troubleshooting equipment and process and must have great teamwork skills. 

What are the top 3 things you are looking for in a candidates experience:

1. Validations experience (Generate, Execute and Close:  IQ, DOE/OQ, Gage R&R, PQ, etc)
2. Equipment/Process troubleshooting
3. Root Cause Analysis 

Education Required:  Engineering Degree

Years’ Experience Required:  2 Years Minimum

Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.

Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.