Sr. Engineer - 33294

mirus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the involved project management.Job Description

• Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
• Develop engineering policies and procedures that affect multiple organizational units.
• Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
• Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
• Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
• Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area
•  Application of mature engineering knowledge in planning and conducting projects.
• Other functions may be assigned
• Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
• Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.
• Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
• Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
• Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.

• Doctorate degree or Master degree and 3 years of Engineering experience or Bachelor degree in Engineering and 5 years of Engineering experience

• Excellent written and verbal communication skills
• Technical writing experience
• Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment.
• Working knowledge and experience with Quality Risk Assessments such as FMEA and/or QRAES
• Experience with change control, nonconformance, corrective and preventative actions, and validation practices
• Experience with Maximo
• Capable of working and/or submitting Purchase Orders (PO)
• Experience working and escorting vendors
• Capable of handling multiple tasks, projects and/or priorities at the same time
• Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration
• Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.

Skills

• Problem Solving and applied engineering
• Basic Technical  Reports.
• Comprehensive understanding of validation protocol execution requirements.
• Verbal communications

This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.