+ **Job Title:** Computer System Validation (CSV) Engineer

+ **Location** : Rockville, MD

+ **Job Type:** Can be either Contract to Hire - or - Direct Hire

+ **Rate/Salary:** Commensurate with experience


This client is changing the way we make and distribute medicinesby providing them to anyone, anywhere, anytime. They are creating innovative manufacturing platforms to enable our vision to produce critical medicines at the point of care and to secure the pharmaceutical supply chain. As a young organization, they offer an exciting opportunity for passionate team members to make a difference in the world while developing career paths for advancement.


The Computer System Validation Engineer will report directly to the Validation Manager, and work across teams, including Operations and Quality, to help ensure that direct impact computerized systems are qualified and maintained in a qualified state. The engineer will also lead the effort to commission no impact computerized 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)

+ Support third-party qualification and commissioning efforts

+ Contribute to System Classification and System Risk Assessment activities

+ Lead efforts for Periodic Review of Qualified Equipment

+ Support the creation and execution of Change Controls and CAPAs

+ Systems include:

+ IT Infrastructure

+ GMP Network

+ Custom-developed LabView applications

+ Programmable Logic Controllers (PLCs)

+ Human Machine Interface (HMI) for filler, Building Management System (BMS), Environmental Monitoring System (EMS)

+ Enterprise Software such as a Computerized Maintenance Management system (CMMS), Quality Management System (QMS), and an electronic Validation platform (Kneat)


**Required Skills:**


+ 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.


**Preferred Skills:**


+ Computer System 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


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.


**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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.