Validation Manager
Lubrizol Life Sciences Health's CDMO business is the leading CDMO for complex formulation development for the pharmaceutical industry, with over 20 years of successful experience and a solid base of clients ranging from the world s largest pharmaceutical and biotech companies to small VC backed start-ups.
As a member of the LLS Health team, you will be working for a company that is engaged in important, exciting, and socially relevant projects.
LLS Health is a fast-paced environment that features a variety of projects, technical challenges, and opportunities for growth.
To learn more about us, visit www.
particlesciences.
com and https:
//www.
lubrizol.
com/Life-Sciences.
At Lubrizol, our Validation Manager is responsible for managing all aspects of validation within the facility.
This will include the scheduling, writing and execution of validation activities for equipment, systems and processes used for the manufacture of various pharmaceutical products in clinical and commercial manufacturing.
The Validation Manager is responsible for ensuring client and business needs are met while providing highest quality of work.
Essential Duties &
Responsibilities:
- Provides day-to-day management of internal and external resources; plans and assigns work for Validation Specialists and/or contingents in order to meet the goals and deadlines set forth.
- Manages multiple and complex validation programs, provides status reports and coordinates with other departments and/or outside contractors/vendors to complete validation tasks.
- Prepares and executes installation qualification (IQ), operational qualification (OQ), performance qualification (PQ) and process qualification (PRQ) protocols for equipment, systems and processes.
- Prepares qualification summary reports (QSR) and validation summary reports (VSR).
- Prepares and/or reviews user requirements, specifications and data sheets for the purchase of new equipment and systems.
- Prepares and executes design qualification (DQ) and traceability matrix (TM) documents.
- Reviews and comments on vendor supplied equipment documentation such as (FRS, DDS, GA drawings, P&ID, etc.
). - Prepares, reviews and executes Factory/Site Acceptance Tests (FAT or SAT) for equipment.
- Prepares, edits and reviews change controls, SOPs, specifications and other related documents.
- Trains, mentors and advises less experienced validation team members.
Required Skills, Qualifications,
Experience:
- Bachelor s degree in Engineering or related scientific degree or equivalent education/training/experience
- 7
years related experience in the pharmaceutical industry with direct experience with equipment qualification and validation. - 2
years experience managing people and projects - Thorough knowledge and training in writing and execution of quality documentation such as IQ/OQ/PQ, SOP, etc.
- Thorough knowledge of cleaning and sterilization validations including CIP, SIP, autoclave, VHP, etc.
- Thorough knowledge of GLP/GMP requirements as they pertain to documentation, equipment, systems and processes
- Mechanical aptitude with the ability and disassemble and assemble process equipment.
- Ability to read and understand technical documentation such as mechanical drawings, P&I drawings, specifications, data sheets, etc.
- Knowledge of validation of 21CFR Part 11 compliant computerized systems and equipment.
- Knowledge and ability to use hand tools and test instruments such as Kaye Validator, multimeters, tachometers, ammeters, etc.
- Strong technical and analytical skills
- Excellent time management, team/people management, and communication skills
- Excellent knowledge and skills of MS Office applications, especially Word and Excel
Lubrizol Life Science Health's CDMO business is located in Bethlehem, PA, part of the Lehigh Valley region of Pennsylvania.
Lehigh Valley includes the cities of Allentown, Bethlehem and Easton.
The region is slightly over an hour to both Philadelphia and New York City, which places you right in the action.
Buzzing with business, culture, knowledge and entertainment, the Lehigh Valley is a vibrant place for people of all ages and walks of life to live, learn, work and play.
This region offers a little bit of everything for everyone - ethnically-diverse communities, affordable housing, award-winning schools and universities, world-class healthcare, ski resorts, museums, casinos, shopping, restaurants, sports and nightlife.
From the yearly Musikfest festival, to skiing in the Poconos, to hiking or biking through the many state parks, you can make it happen right here in the Lehigh Valley.
Lubrizol is an equal opportunity employer.
Qualified applicants will receive consideration for employment without regard to sex, race, color, national origin, citizenship, age, religion, marital status, military service, sexual orientation, genetic information, gender identity, or any other characteristic or trait protected by federal, state, or local law.
Do You Need Assistance?
Please let us know if you need an accommodation to proceed with your application for a posted job, or with any other aspect of the interview or assessment process.
You can either call 440-943-4200 and ask for Talent Acquisition or send an email to talentacquisition@lubrizol.
com.
Please note that this phone line and email address are not to be used for checking on the status of an already submitted application and not to be used by third party recruiters.
Estimated Salary: $20 to $28 per hour based on qualifications.
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