Validation Engineer

3 weeks ago

Carolina, United States Pulivarthi Group Full time
Job DescriptionJob DescriptionJob Title: Validation Engineer
Location: Remote
Duration: 12 monthsCompany Overview:
Pulivarthi Group is a premier global provider of staffing and IT technology solutions, renowned for delivering exceptional services tailored to each client's unique needs. With a steadfast commitment to excellence, we merge expertise with innovation, ensuring cost-effective solutions of the highest quality. Our diverse client base spans healthcare, finance, government, and beyond, reflecting our adaptability and proficiency across industries. Operating in the United States, Canada, and Mexico, we pride ourselves on aligning with clients' cultures, deploying top-tier talent, and utilizing cutting-edge technologies. Pulivarthi Group stands as a beacon of reliability, efficiency, and innovation in the realm of staffing solutions.Job Overview/Summary:
The Validation Engineer is a hands-on position responsible for providing support for maintenance, validation, and commissioning activities while ensuring current Good Manufacturing Practices (cGMP) are followed. The individual will be responsible for qualifying new equipment, maintaining regulatory compliance, and managing continuous improvements. The Validation Engineer will report to the Validation Manager and work collaboratively with a cross-functional team.Job Responsibilities:
Support all aspects of the equipment and facility validation life cycle from design through operation, release, continuous improvement, and retirement.
Responsible for commissioning and qualification of GxP instruments, equipment, utilities, and facilities.
Support the preparation of validation documentation such as qualification protocols, risk assessments, and periodic reviews.
Author, review, and approve technical documents needed for the qualification of equipment and processes.
Coordinate validation activities with other departments to ensure validation projects are carried out on time and produce minimal downtime.
Work collaboratively with internal stakeholders and, as necessary, external partners/vendors.
Work closely with equipment vendors to ensure thorough and accurate documentation is gathered during qualification processes.
Maintain engineering and validation records in both hard copy and electronic form.
Manage the design, specification, and installation of new/renovated process equipment and facilities modifications.
Identify and mitigate risks to ensure business continuity and protect the company from loss.
Collaborate and manage conflict in a fast-paced environment, working across functions.
Prepare documentation of activities, actions, and/or results.
Monitor records to ensure compliance with regulatory requirements.
Ensure proper documentation practices during job activities.
Answer compliance and process questions.
Communicate policies and procedures to employees.
Communicate priorities and progress to the team on a continuing basis.
Initiate appropriate action when process deviations occur.
Attend inter-departmental meetings to discuss matters involving the coordination of multiple departments.
Participate in cross-functional teams to meet strategic goals.
Read and interpret diagrams, drawings, and other schematics.
Comfortable in a fast-paced, collaborative company environment, working with minimal direction, and able to adjust workload based upon changing priorities.Other Duties:
Participate in troubleshooting activities.
Interact with regulatory agency personnel during audits and inspections.
Recommend and initiate activities to ensure the area and equipment are maintained in a state of compliance.
Recommend compliance resolutions to management.Minimum Qualifications:
Experience working in a regulated or cGxP environment.
Ability to identify and implement solutions.
Excellent oral and written communication skills with the ability to present results clearly and logically.
Demonstrated ability to work in a dynamic, fast-paced team environment and to meet timelines.
Capable of multi-tasking and good organizational skills.
Strong knowledge of cGMP Quality Systems.
Proficient in Microsoft (Excel, Word, Outlook).
Thorough understanding of cGMPs.
Must be able to wear appropriate clean room attire (i.e., surgical masks) and all Personal Protective Equipment (PPE).Preferred Qualifications:
3 years of experience supporting validation or quality in a Biopharma cGxP environment.
4-year degree in Engineering / Science or equivalent.
Background in Laboratory Equipment.
Use and knowledge of different data logging devices and software.
Experience with Computer System Validation/21 CFR Part 11.
Experience with Veeva document management and/or Blue Mountain Computerized Maintenance Management System.Equal Opportunity Statement:
Pulivarthi Group is proud to be an equal opportunity employer. We are committed to building a diverse and inclusive culture and celebrate authenticity. We do not discriminate on the basis of race, religion, color, national origin, gender, gender identity, sexual orientation, age, marital status, disability, protected veteran status, or any other legally protected characteristics.

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