JOIN OUR TEAM! 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. What we offer: Competitive salaries Ability to earn additional income based on hours worked (Biweekly basis) Free High-Quality webinars provided by experts from around the world Committed to keeping our consultants in project continuity Referral Program Wellness Program Recognition Program (for employees only) Service Award Program (for employees only) Discount Program (for employees only) An administrative team that is oriented to providing excellent service that pursues satisfying the needs of our consultants. For our projects in the US, we cover travel/lodging/transportation expenses (employees only) General Description: PharmaLex Puerto Rico is seeking an experienced consultant who can provide support as Commissioning, Qualification (CQ) in Utilities Specialist for a variety of projects. Each qualified candidate will be responsible for coordinating commissioning, qualification and validation activities across all operational areas and ensuring activities are conducted promptly by cGMP and appropriate regulatory expectations for a regulated industry located in Manati, Puerto Rico. SUMMARY: Designs and develops production layouts for the manufacturing operations to increase productivity and quality standards. Their main duties include reviewing current production schedules and processes to find potential improvements, designing the layouts of the facilities, operations, and estimating production costs. ROLE AND RESPONSIBILITIES: Establish engineering policies for a major segment of the company. Interpret, execute, and recommend modifications to company-wide policies. Develop organizational budgets or project budgets encompassing all disciplines for large or complex project. 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. Plan, organize and coordinate work of a staff of engineers and/or technicians. Lead efforts 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 or process modifications. Established a corporate Engineering resource, specializing in more than one area of engineering. Designs, executes, implements and directs engineering or process projects which significantly contribute to attaining high priority goals QUALIFICATIONS: Working knowledge of pharmaceutical/biotech processes Familiarity with validation processes Familiarity with documentation in a highly regulated environment Ability to operate specialized laboratory equipment and computers as appropriate. Ability to interpret and apply GLPs and GMPs. Ability to apply engineering science to production Able to develop solutions to routine technical problems of limited scope. Demonstrated skills in the following areas problem-solving and applied engineering. o Basic technical report writingo Verbal communication Comprehensive understanding of validation protocol execution requirements. Required: Multiple years of experience in filling process validation, characterization or commercial support. Experience in Process Characterization and Data analysis. Availability to support non-standards shift that may include extended and/or weekend shifts as per business needs PharmaLex is an Equal Opportunity Employer. Job Types: Full-time, Contract 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. Powered by JazzHR
