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A Range of Possibilities

Validation Engineer Principal-Ridgefield, NJ

date posted 02/11/2019
contract type Full time
job id R2493154
location Ridgefield, New Jersey

JOB DESCRIPTION

  • Assists in the change management for validated processes.
  • Assists in development and management of Validation Programs/Processes.
  • Generates and maintains project Validation Plans.

BASIC QUALIFICATIONS:

  • Bachelor degree with minimum of 10 years related experience.

  • Effective organization and project management skills.
  • Effective troubleshooting and problem solving skills.
  • Proven skills in managing major Validation projects.
  • Ability to maintain gowning requirements as needed to access controlled areas.
  • Ability to manage multiple projects simultaneously.
  • Ability to work both independently and in conjunction with a team.
  • Develop and implement creative solutions to problems.
  • Proficient knowledge with MS Office.
  • Proficient knowledge of GMP regulations and validation guidelines.
  • Proficient knowledge and experience in writing protocols and following procedures.
  • Experienced with validation tools such as Kaye Validator.
  • Excellent oral and written communication skills demonstrated through interactions internally and externally.
  • Manages re-qualification schedules/activities.
  • Manages schedules and coordinates Validation activities with cross-functional teams.
  • Manages and generates protocols/reports and executes Validation activities for the following:
    • GMP Manufacturing Facilities;
    • Temperature controlled environments (Warehouse, Stability Chambers, Incubators, Freezers, Refrigerators, etc);
    • Injectable aseptic manufacturing equipment (Fillers, Bulk Tanks, etc.);
    • Utilities (WFI, Purified (USP), Clean Steam, Gases, etc.);
    • Sterilization equipment (Autoclaves, Dry Heat Ovens, Steam in Place (SIP), Isolators, etc.);
    • Cleaning Validation (Clean in Place (CIP), Parts Washer);
    • Laboratory Information Management Systems (LIMS);
    • Shipping Validation;
    • Packaging Equipment;
    • Process Validation (Phase I, II and III (Continuous Process Validation))
  • Manages and provides guidance and technical expertise in cycle development initiatives and activities.
  • Manages and provides guidance and technical expertise in cleaning and process development/commercial activities.
  • Collaborates with Management personnel as needed.
  • Participate in audits and follow up on corrective actions.
  • Train mentor and supervise junior associates in validation principles.
  • Perform other related duties as assigned.

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.

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: #LI-GZ

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.

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