Validation Engineer I, Northborough, MA

Job description

**Monday-Friday- 8-4:30pm (With flexibility)**

Validation Engineer I, Northborough, MA

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Department Description:

The Northborough (NBO) Validation department reports in through the NBO Quality Organization and is responsible for the qualification / validation of all facility-related equipment, critical utilities and processes in compliance with industry practices and regulatory requirements. Customer Groups include: Logistics/Warehouse Groups, Supply Chain, QCRM, Stability, Validation, Label &Pack, Facilities

Responsibilities include project support for new equipment/systems, as well as maintaining compliance of the routine Requalification (RQ) program, ensuring systems are maintained in a validation state, and ensuring uninterrupted business continuity.

Overview of Department Responsibilities:

·  Controlled Room Temperature (CRT) Warehousing Spaces
·  Temperature Controlled Environmental Rooms & Chambers
·  Critical Utilities / Facility, including EMS
·  Label & Packaging Secondary Packaging Equipment
·  Transportation Validation (Temperature Controlled Trucks)
·  Cold Chain (Active and Passive Shippers)

Position Overview with Key Responsibilities:

·  Perform validation activities in a GMP biotech warehouse, raw material hub, and secondary packaging facility.
·  Ensure adherence to world-wide regulatory requirements and corporate standards.
·  Ensure assigned requalifications (RQs) are completed on-time.
·  Write and execute validation protocols (DQ, IQ, OQ, PQ, PV, RQ) as well as write comprehensive final reports containing thorough resolution of protocols discrepancies and deviations.
·  Provide technical assistance to less experienced technicians/engineers
·  Work as part of a team to ensure that validation activities are completed on-time and correctly.
·  May manage small size validation projects and change control based qualification/validation activities.
·  Perform SOP revision, review and approval.
·  Generate deviations, CAPAs, perform investigations and root cause analysis.
·  Present and defend validation studies during regulatory inspections and internal audits.
·  An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
·  Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.
·  Being honest and treating people with respect and courtesy.
·  Constantly striving to make Sanofi a great place to work, and a company respected for the quality of its people and products.
·  Acting as role models for our fellow employees by acting responsibly, fairly and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

·  Associates degree with 3+ years of experience, Bachelor's degree in engineering/science (preferred) and 2+ years (or high school degree with 5+ years experience) of hand-on validation experience in Biotech, Pharmaceuticals, or Medical Device Operations, including protocol development and field execution.
·  Knowledge of Validation Lifecycle Approach (DQ, IQ, OQ, PQ, PV, and RQ).
·  Basic knowledge of applicable US and worldwide regulatory requirements (e.g. GMP, GDP)
·  Ability to develop protocols using design documents and user requirements
·  Ability to perform basic statistical analysis of validation test results
·  Excellent technical writing and verbal communication skills.
·  Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project and Visio.

Preferred Qualifications:

·  Proficient in use of GE/Kaye Validator and/or wireless datalogger systems.
·  Ability to read/interpret engineering drawings and design documents.
·  Basic troubleshooting of system failures.
·  Experience of working across organizations in highly matrixed/team environment.
·  Experience with Cold Chain Validation and/or Secondary Packaging Equipment

Special Working Conditions:

·  Ability to lift 20 lbs.
·  Ability to gown for entry into classified spaces.
·  Work (protocol execution) may be required in locations that have temperature, chemical, or pressure/noise hazards. Areas such as cold rooms, freezer rooms, laboratories, and mechanical/utility areas. Appropriate PPE and caution is required.
·  This position may require some off-shift availability (i.e. 2nd or 3rd shifts), when necessary potentially including weekends and holidays (typically 5-10% of the time.
·  This position may require some travelling (typically 5-10% of the time and typically limited to inter-site travel within the Massachusetts network).

Grade:

L1-1

If you want to learn more about compensation grades, please go to our grade guide via the following link:

http://mysanofi.sanofi.com/sites/HR-Corporate/Pages/eEdiPrVI/Global_Grading.aspx

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 achieves its mission, in part, by offering rewarding career opportunities which inspire employee growth and development. Our 6 Recruitment Principles clarify our commitment to you and your role in driving your career.

Our people are responsible for managing their career

Sanofi posts all non-executive opportunities for our people

We give priority to internal candidates

Managers provide constructive feedback to all internal interviewed candidates

We embrace diversity to hire best talent

We expect managers to encourage career moves across the whole organization

A few practical tips:

Be sure to regularly update your Workday profile to simplify the application process

Be aware of any applicable eligibility criteria in the country to which you are applying

Before applying, inform your manager so they may support your career development goals

Sanofi careers - it all starts with you!

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.

#GD-SG

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.