Preferred Qualifications:
Experience in validation and in aseptic room classification. Knowledge in Media Fills and Air Visualization studies is desirable.
Functions:
Establish validation policies for a major segment of the company. Interpret, execute, and/or recommend modifications to company-wide policies. Apply advanced technical principles, theories, and concepts in the development of new principles and concepts. Perform work that involves in-depth investigation of subject area, definition of scope, selection of areas of investigation, and development of novel concept. Conceive plans and conduct engineering research/investigation in areas of considerable scope and complexity. Lead efforts with manufacturing, process development, utilities, facilities, labs, and /or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications. Expert validation knowledge (equipment qualification, cleaning, sterilization). Provide technical validation solutions to a wide range of difficult problems through individual efforts as well as strategic leveraging of outsourced personnel. Works under consultative direction toward predetermined long-range goals and objectives. Develops advanced technological ideas and guides their development into a final product. Has full responsibility for interpreting, organizing executing and coordinating assignments. Essential to the completion of corporate wide initiatives and programs.
Expected to be capable of managing complex project objectives or multi-tiered organization. May be expected to directly supervise staff or project resources. Serves as organization spokesperson on advanced projects and/or programs. Acts as advisor to management and customers on advanced validation engineering studies and applications.
Education:
Doctorate degree and 2 years of Validation experience or Master’s degree and 6 years of validation experience or Bachelor’s degree and 8 years of validation experience.
Note:Position is for a first shift, but flexibility is required as necessary for the 2nd and 3rd shift on occasions related to validation process that may need to be covered in all shifts.
Job Type: Contract
Experience:
Media Fill & Air Visualization Studies: 8 years (Required)
Process Validation: 5 years (Required)
Education:
Bachelor's (Required)
Language:
Spanish & English (Required)
Contract Length:
More than 1 year
Full Time Opportunity:
No
Additional Compensation:
Other forms
Schedule:
Monday to Friday
Night shift
Overtime
Other
