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Senior Computer Systems Validation Engineer
Location:
The Woodlands, TX
Description:
"Bridging Innovation to Cure" D eveloping and Manufacturing your cell therapies from benchtop to bedside Position Summary Cellipont Bioservices is growing, and we are looking for an Senior Computer Systems Validation Engineer (CSV) who believes in the potential bridging client's discoveries to patient cures and who wants to challenge the status quo and take Cellipont and its clients to the next level. The Senior Computer Systems Validation (CSV) Engineer supports the Validation Director by ensuring effective implementation and maintenance of the Computer Systems Validation (CSV) program. Ensures compliance with applicable US regulations, guidance, industry standards, and Cellipont policies/procedures supporting the commercial GMP manufacturing of biological drug substances and drug products. Serve as a CSV subject matter expert, and track and report action plan status/ completion as relates to validation systems improvement efforts. Responsible for the development and execution of qualifications, validations, re-qualifications, and re-validation for facilities, utilities, systems, and equipment (FUSE), focusing on the computer validation aspects of the systems. The Role Thorough knowledge of validation life cycle, validation protocols (IQ/OQ/PQ) generation and execution of manufacturing and laboratory equipment, clean process utilities and classified facilities Fundamental understanding of validated computer systems and change management in the commercial pharmaceutical/biotech industry, including training others. GMP compliance knowledge including knowledge of 21 CFR Parts 210, 211, 11, GAMP 5 and ISO 13485:2003 requirements, among others. Generates and executes (as applicable) User Requirements, Design Specification, Functional Specification and Traceability Matrix. Produces Validation Plans, IQ/OQ/PQ Protocols, test scripts, and SOPs as required to meet 21 CFR Parts 210, 211, 11, GAMP 5 and ISO 13485:2003 requirements among others. Works with CSV Gap Assessments and Remediation Plans with an understanding of applying risk management principles. Supports regulatory and client audits as CSV subject matter expert. Able to work independently (author protocol, execute studies, analyze data, author reports). Advanced knowledge of discipline; able to discuss regulatory expectations for validation activities, program and documentation. Able to handle some larger and more complicated project work with minimal supervision/oversight. Demonstrated ability to plan and organize validation activities amongst cross functional groups; capable of providing and maintaining status updates for CSV activities related to day-to-day operations or project work. Capable of independently discussing validation philosophies in the presence of the Validation Director, during customer audits or regulatory inspections. Able to correctly answer questions about day-to-day activities that would be most likely posed by other departments and Jr. Validation Engineers. Participates in the initial assessment of change controls for process, laboratory, classified facilities and clean process utilities. Assessment primary focus being in the CSV portion of the system/equipment Able to correctly assess large and complex change controls with an accurate understanding of the bigger picture implications of changes. May still need some review and oversight or feedback. Provide CSV support for deviations related to Engineering, Facilities, Automation, IT, Quality Control and Validation Generates CSV Assessment Forms for new equipment and existing equipment (if applicable) Develops/Maintains Develops/Maintains CSV Facilities, Utilities, Systems and Equipment (FUSE) Master List Performs validated equipment/systems periodic review. Generates review reports. Support the Risk Management Program to evaluate and mitigate risks associated with equipment and facilities as appropriate using tools such as Failure Modes Effects and Analysis (FMEA), Fault Tree Analysis (FTA) or other available risk management tools. Serve as the QA-CSV resource for expansion projects which includes construction of cleanrooms, commissioning, and qualification of utilities such as HVACs, Process Gases, Water for Injection (WFI), automation systems and fill lines Review and approve Standard Operating Procedures (SOPs) Participate in site and corporate quality and process improvement initiatives. Support client and regulatory audits. The Candidate Bachelor's degree in a Science or Engineering field with 8 years of experience or Master's degree with 6 years of experience in pharmaceutical, biotechnology, or related industry. In-depth knowledge of FDA guidelines and Global cGMPs relevant to 21 CFR Part 11 compliance requirements and Global Computer System Validation and ISPE GAMP guidelines Experience performing/supporting computer systems validations associated with IQ, OQ & PQ for software systems (SCADA, PI Historian, BMS, EMS, TrackWise, etc.) Able to work in a team setting and independently under minimum supervision. Knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks Experience with Facility Expansion and Data Integrity Remediation programs are a plus Position Benefits Opportunities for career growth within an expanding team Defined career path and annual performance review & feedback process Cross-functional exposure to other areas of within the organization Robust benefit package designed for unique Health & Wellness needs, including coverage for your furry family members 401K strong employer match Tuition Reimbursement Employee Referral Bonuses Flexible work schedules and PTO based on role/level, increasing 1 PTO day each year and paid holidays Gain experience in the cutting-edge cell therapy space "At Cellipont Bioservices, we look for candidates with an innate desire to serve. Our "family" approach ensures you will get the mentorship you need to develop a satisfying career here!" Notice to Agency and Search Firm Representatives Cellipont Bioservices is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Cellipont Bioservices employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Cellipont Bioservices. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Company:
Cellipont Bioservices
Posted:
May 1 on ApplicantPro, TalentPlusHire
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More About this Listing: Senior Computer Systems Validation Engineer
Senior Computer Systems Validation Engineer is a Engineering Validation Engineer Job at Cellipont Bioservices located in The Woodlands TX. Find other listings like Senior Computer Systems Validation Engineer by searching Oodle for Engineering Validation Engineer Jobs.
Senior Computer Systems Validation Engineer is a Engineering Validation Engineer Job at Cellipont Bioservices located in The Woodlands TX. Find other listings like Senior Computer Systems Validation Engineer by searching Oodle for Engineering Validation Engineer Jobs.