Sanofi Group Validation Specialist I-Ridgefield, NJ in Ridgefield, New Jersey
Summary of Responsibilities:
Perform a variety of moderately complex to complex tasks with minimal supervision in accordance with current cGMP, company, and departmental standards in a given protocol. This may include calibrating test instrument, qualifying equipment, and validating simple processes. Perform hands on qualification / validation execution work, e.g. Autoclave sterilization, Steam-In-Place, Clean-In-Place, VHP Decontamination, and Temperature Mapping studies. Generate qualification / validation protocols and reports, from a set template, for repetitive systems or assist in protocol development of new equipment or system.
This position is needed to work with minimal supervision or independently with direction, and the work will be reviewed for soundness of judgment and overall adequacy / accuracy. This position will also consistently require to make independent decision and to exercise independent judgment. In addition, the duties of this position require advanced knowledge in specialized field of learning , e.g. Moist Heat Sterilization, Isolator with VHP Decontamination, Stability Chamber / Temperature Control Unit, simple equipment and Laboratory Instrument, simple PLC control system…etc.
This position will also contribute to the completion of milestones associated with specific projects or routine technical tasks. Failures to achieve results or erroneous decisions or recommendation may cause delay in program schedule and may results in the allocation of additional resources. The position will be the primarily internal company contacts or infrequent inter organizational / outside customer contacts.
A minimum Bachelor's degree in Engineering or Science discipline with minimum 1 years of Pharmaceutical or Bio-tech manufacturing related experience OR
A minimum Bachelor's degree (other academic disciplines) with 2 to 3 years of Pharmaceutical or Bio-tech manufacturing related experience.
Good Verbal and Writing Communication skill – for scheduling qualification / validation studies.
Good Technical Writing Skill is a plus.
Experience in creating validation and qualification documents, based upon template document, is a plus
Knowledge of utilizing Kaye Validator and / or Valprobe software is a plus
Knowledge on operating an autoclave is a plus.
General Working Hour:
Normal working hour: 8:00 a.m. to 5:00 p.m. , M – Fr. This position might require working flexible hours, i.e. 2nd / 3rd shift, weekend, or holiday, based upon projects need.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
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