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22 days old

Sr. Validation Engineer

Kelly Services
Windsor, CO 80550
Note: This is a full-time, direct-hire,No C2C, 3rd party or H-1B at this time. This position is ONSITE in Windsor, CO (80550). We appreciate all of our applicants, but we are not able to sponsor at this time. Pay up to112k.



Responsible for the development, execution, review and coordination of validation activities including, commissioning, qualification, and validation (CQV) of facility, utilities, manufacturing process equipment, and cleaning validation for product manufacturing facilities.



**Essential Duties & Responsibilities**




+ Responsible for the change management for validated processes and equipment.

+ Develops validation strategies for complex validation projects.

+ Prepare and maintain site and project Validation Plans.

+ Maintain and manage re-qualification schedules.

+ Plan and coordinate specific validation activities for projects.

+ Provide validation input to Engineering and Maintenance in equipment purchase requirements.

+ Generate protocols and perform execution in the following validation areas;

+ Temperature mapping of warehouses and temperature controlled chambers.

+ Aseptic manufacturing equipment IQ and OQ

+ Non-sterile manufacturing equipment IQ and OQ

+ Utility system IQ and OQ

+ Laboratory equipment IQ and OQ

+ Automated systems qualifications

+ Sterilization process PQ (Autoclaves, Dry Heat Ovens, Process SIP, VPHP)

+ Cleaning validation (CIP/COP)

+ Aseptic media simulations

+ Product Process Validation




+ Interface with Engineering, Facilities, Regulatory, and Manufacturing personnel as needed.

+ Review and approve cycle development initiatives and activities.

+ Perform other related duties as assigned.



**Knowledge, Skills & Abilities**




+ Good technical skills and the ability to understand technical documentation such as equipment manuals or drawings.

+ 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.

+ Effective organization and project management skills.

+ Effective troubleshooting and problem solving skills.

+ Ability to maintain gowning requirements as needed to access controlled areas.

+ Ability to manage multiple projects simultaneously.

+ Ability to work effectively both independently and in conjunction with a team.

+ Develop and implement creative solutions to problems.

+ A valid drivers license and acceptable motor vehicle record required.

+ Ability to train junior associates in validation principles.



**Core Values**




+ The Senior Validation Engineer is expected to operate within the framework of Tolmars Core Values:

+ Consistently operate with the highest standards of ethics and compliance.

+ Take ownership of your actions, success and setbacks.

+ Respect each other and understand that honest collaboration is at the heart of our company success.

+ Go the extra mile to make things happen.

+ Be committed to all we do and the patients we serve.

+ Embrace change with enthusiasm.

+ Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.



**Education** **& Experience**




+ Bachelors degree in Engineering or Science related field.

+ Five or more years experience in the pharmaceutical industry, minimum four years in validation required.

+ Demonstrated experience in four or more validation areas.



**Working Conditions**




+ Working conditions are normal for an office environment.

+ Work may require occasional weekend and/or evening work.

+ Work inside manufacturing clean rooms where gowning is required.



**Qualifications**



**Required**



Bachelors or better in Engineering or related field.



**Required**



Experience in four or more validation areas.



**5 years:** Experience in the pharmaceutical industry, minimum four years in validation required.









If interested directly email resumes to jenh374@kellyservices.com




**Why Kelly** **** **?**



Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity, and professionalism. Whether you seek the variety and flexibility of working on short-term project engagements or prefer contract-to-hire or direct-hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.
Posted: 2019-11-15 Expires: 2019-12-16

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Sr. Validation Engineer

Kelly Services
Windsor, CO 80550

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