Senior Engineer

QRC Group•Aibonito, PR

About The Position

Provide a wide range of work to fully support the manufacturing processes and products. Implement, plan, and coordinate inter- departmental activities related to process improvements and product support. Responsible for the diverse range of project activities related to process and product development, introduction, studies development process, investigations, and validations.

Requirements

BS in Engineering or Science Field and 3-5 years related experience in manufacturing or project engineer in a closely related industry or MS in Engineering and 1-2 years related experience in manufacturing or project engineer in a closely related industry.
Bilingual (Spanish and English) written and verbal.

Responsibilities

Participate in multi-functional projects to contribute with plant manufacturing strategies.
Use standards and advance technical principles to analyze and resolve process-related issues.
Works under minimal supervision to identify manufacturing problems and respond to production requests for assistance.
Plan, coordinate and execute validation activities. Provide documented evidence of validated submissions, equipment, control systems and manufacturing processes.
Present and defend to FDA (and all other regulatory bodies) validation protocols, results, and documentation.
Clear understanding of company validation approach for equipment/process and computer software systems.
Capable of recognizing the complexity of posed problems and providing appropriate technical recommendations.
Manage resources to clearly set workload priorities to support the manufacturing areas effectively.
Interact with Divisional and International Facilities, outside Consultants and Suppliers to provide the best available technical support.
Coordinate process or product transfer activities from Divisional or International facilities to the manufacturing areas.
Coordinate Change Controls, product, or process validations, by acting independently to achieve desired goals.
Perform and assist in the implementation of new product introductions, existing product design modifications, manufacturing improvements giving direct support on change process as change control owner and /or action owner on local or divisional projects.
Perform statistical and analytical analysis on process or product related conditions. Use Six-sigma engineering tool.
Maintain contact with Divisional or International Offices on a consistent basis.
Strong negotiation skills required, ability to work with minimal supervision and under pressure.
Promote a zero-harm workplace and assure that required EHS resources are available and that all applicable EHS practices and rules are being followed by supervised employees.
Observe data privacy and confidentiality rules at all time.
Work as a team player in the implementation of a capital project in the plant.
Write, execute and/or support SAT, FAT, IQ, SQ, OP and PQ.
Write and review URS documents.
Provide aid and support to Manufacturing Department. in the selection and/or implementation of V.l.P. Projects.