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PharmaLex is a highly successful and growing consulting company for the Healthcare industry around the world.
PharmaLex offers professional development, plus a stimulating and collaborative work environment.
We are committed to providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm, and diligence.
General Description: PharmaLex Puerto Rico is seeking a experienced consultants who can Independently provide and/or direct the technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment for a Biotechnology industry located in Juncos, Puerto Rico.
KEY RESPONSIBILITIES AND ACTIVITIES Able to troubleshoot systemic validation issues.
Applies advanced and diverse validation engineering principles to the design and implementation of major system or process modifications and/or capital projects.
Develops, organizes, analyzes and presents interpretation of results for operational issues or validation engineering projects of significant scope and complexity.
Complete complex or novel assignments requiring development of new and/or improved validation engineering techniques and procedures.
Develop validation engineering policies and procedures that affect multiple organizational units.
Supervise, coordinate and review work of a small staff of engineers and/or technicians on an ongoing basis as well as on a project basis.
Employ advanced validation engineering techniques and/or modifications of advanced techniques within area of validation engineering expertise.
Apply knowledge of validation engineering principles and practices outside of area of expertise to broad variety of assignments in related fields.
Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
Work 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.
Work with project managers to complete the validation responsibilities of engineering projects within schedule, budget and quality constraints.
Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.
Prompt and regular attendance to the workplace.
Other functions may be assigned REQUIREMENTS Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience Shift: 8hrs shift - Due to the nature of the work (support to new product introductions, projects optimization and commercial manufacturing) non-standard shift might be required (coverage outside day shift such as second/third shifts, weekends, holidays) Preferred educational background: Engineering (any field) or scientific background (Biology, Microbiology, Biotechnology, Chemistry, etc.)
Previous experiences in regulated environment (Biotechnology, Pharmaceutical, Medical Devices, etc.).
Experience in Validation with preference in Process Validation.
PharmaLex is an Equal Opportunity Employer.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law.
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