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11 days old

Validation Engineer

Kelly Services
Bryan, TX 77808
**Validation Engineer**

**Salary: $100-128,000**


**MISSION OF THE POSITION:**

The Validation Engineer will be a team player in a small company environment in this highly cross functional role. He/She will be responsible for all activities for the validation department, including the scheduling and execution of qualifications and validations of manufacturing facilities, utilities, equipment, and processes and overseeing the site Master Validation Plan.


**WORK LOCATION:**

The Validation Engineer position is located in Bryan, Texas.


**DUTIES & RESPONSIBILITES:**


+ Oversee the site Master Validation Plan, using input from internal and external resources for continuous improvement.

+ Creates, coordinates, and enforces Validation systems, policies, and procedures Responsible for periodic assessment and requalification program, PPQ (Process Performance Qualification), Cleaning and CSV (Computer System Validation) Manage validation department personnel; hire, train, coach, and develops staff within the Validation team Monitor the performance of the validation department by tracking appropriate metrics and reporting the results to management. Responsible for the day-to-day activities conducted by the Validation Department; establishes priorities to ensure that deadlines are met and budgets are not exceeded

+ Liaise with outside vendors as a representative of validation and supervises the activities of external validation contractors

+ Oversee development and approval of Validation SOPs and validation-specific documents

+ Support commissioning activities, projects, and validation functions by performing, preparing and reviewing/approving validation protocols and other documentation.

+ Generate validation final reports as needed Act as the Validation SME for manufacturing operations

+ Assess change controls with an accurate understanding of the bigger picture implications of changes

+ Communicate validation activities and schedules to other departments as required

+ Work closely with cross functional teams to ensure all work is completed to high quality in a timely and scientifically rigorous manner


**KNOWLEDGE, SKILLS, & ABILITIES:**


+ Working knowledge of validation and GxP requirements for biologics manufacturing

+ Working knowledge of requirements for aseptic manufacturing

+ Familiarity with multi-product manufacturing facility

+ Ability to operate Kaye (or other) validation equipment and interpret resulting data and discussing validation policies and philosophies during audits/inspections by internal and external entities

+ Ability to interpret cGMP requirements

+ Ability to forecast and manage and prioritize multiple projects or assignments at one time, including the ability to follow assignments through to completion and meet deadlines

+ Must have strong organizational skills and excellent communication (verbal and written) skills Problem-solving skills and ability to make quality decisions based on technical facts and sound risk assessments is required


**EDUCATION & EXPERIENCE:**


+ Bachelor's degree or equivalent in related technical discipline required

+ 2-4 years of relevant experience in validation in the biotech/pharmaceutical industry required


\#P2


**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.
Posted: 2022-09-23 Expires: 2022-10-24

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Validation Engineer

Kelly Services
Bryan, TX 77808

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