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22 days old

Equipment Validation Engineer -- Great opportunity

Kelly Services
Rockville, MD 20851
Kelly has been providing outstanding employment opportunities to the most talented individuals in the marketplace for more than 70 years. We are proud to offer a permanent opportunity with a pharmaceutical company that is on the cutting edge of technology. They are looking for Equipment Validation Engineer for their facility in Maryland.


This job offers competitive pay, comprehensive benefits and relocation assistance.


The Equipment Validation Engineer will report directly to the Validation Manager, and work across teams, including Operations and Quality, to help ensure that direct impact equipment is qualified and maintained in a qualified state. The engineer will also lead the effort to commission no impact equipment systems as needed.


**Duties/Responsibilities**


+ Participate in development of User Requirements, Installation, Operational, and Performance Qualification Protocols

+ Execute IQ/OQ/PQ protocols

+ Knowledge of Good Documentation Practices

+ Knowledge of the equipment delivery standards such as 21 CFR Part 11 Compliance, Data Integrity, and ASTM2500

+ Assist in the writing of Standard Operating Procedures (SOPs)

+ Lead direct impact equipment validation efforts

+ Lead no-impact equipment commissioning efforts

+ Support Cleaning Validation and Process Validation as necessary

+ Support third-party qualification and commissioning efforts

+ Contribute to System Classification and System Risk Assessment activities

+ Assist the Research and Development (R&D) engineering and chemistry teams in defining requirements and reviewing Engineering Turnover Packages (ETOPs)

+ Lead efforts for Periodic Review of Qualified Equipment

+ Support the creation and execution of Change Controls and CAPAs

+ Systems include:


+ Clean rooms

+ Aseptic Filler

+ Air Handlers

+ Steramist sanitizer


+ Vision inspection

+ Filter integrity testing

+ Climet particle counters

+ Dispensing Powder-Containment hood

+ Dispensing Scales


+ Custom-made in-house equipment

+ Nitrogen Distribution System

+ Biosafety Cabinet

+ Formulator


**Preferred Skills/Abilities:**


+ Equipment Validation experience within the medical device, laboratory, or pharmaceutical industries

+ Good understanding and application of Current GMPs, regulatory requirements, and Good Engineering Practices.

+ Excellent communication / interpersonal skills

+ Be a motivator and leader within the team

+ Attention to detail


**Education and Experience:**


+ Bachelors degree in science/engineering/computer systems as a minimum.

+ At least 5 years of experience in delivering validation projects

+ Experience with any of the following is a huge plus: ISPE C and Q, 21 CFR part 210/211, ICH Q 8, 9, 10, and/or GAMP5


**Required Skills/Abilities:**


+ A Can do problem solving attitude and approach.?

+ Effective communication skills and an ability to work efficiently across multi-disciplinary teams to help achieve organizational objectives?

+ Excellent analytical and problem-solving skills.?

+ Excellent written and verbal communication skills.?

+ Excellent organizational skills and attention to detail.?

+ Adept at navigating and building strong and professional relationships with all ODP personnel and partners.?

+ Sets an example by modeling the required behaviors and holding other employees and peers accountable for their actions by identifying and acting on behavior which is inconsistent with company and safety standards.?

+ Able to multitask and adapt quickly to new requests and needs.?

+ Contributes to a work environment where performance management, continuous quality improvements in service and professional practice are pursued.?


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


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**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 (plus, did we mention we provide a ton of benefits ?). 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2022-06-03 Expires: 2022-07-04

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Equipment Validation Engineer -- Great opportunity

Kelly Services
Rockville, MD 20851

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