Computer Systems Validation SpecialistKatalyst HealthCares & Life Sciences • Triangle, NC
Computer Systems Validation Specialist
Katalyst HealthCares & Life Sciences • Triangle, NC
[job_card.30_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]
Roles & Responsibilities:
Roles & Responsibilities:
- Support implementation of a new MES for drug substance manufacturing operations.
- Contribute across multiple phases including electronic equipment tracking, electronic batch records, and release-by-exception functionalities.
- Support the Quality Engineering workstream to ensure the site is prepared to adopt and sustain MES capabilities within routine production.
- Review and support execution and documentation of the CSV Program in accordance with the full CSV lifecycle, Documentation requirements, Validation plans and risk assessments, Functional requirements, Configuration specifications, Testing activities, Change control documentation.
- Validation and compliance reviews.
- Ensure project deadlines and quality performance standards are met for all CSV-related activities.
- Maintain up-to-date knowledge of applicable regulatory requirements impacting CSV.
- Review and approve computer systems in the field, including manufacturing and automation systems.
- Partner with Automation Engineering and system owners to resolve deviations identified during testing.
- Provide timely responses to management and end users regarding project or system inquiries.
- Deliver frequent status updates on CSV activities and project progress.
- Collaborate with project teams, contractors, system owners, and site operations staff.
- Report key activities and issues to the Senior Manager of Quality Engineering.
- + years of MES experience (required).
- Prior experience with Syncade MES strongly preferred.
- Hands-on knowledge of CSV within GxP-regulated pharmaceutical manufacturing environments.
- Ability to work effectively in a fast-paced, open-office setting with frequent distractions.
- Strong communication skills and ability to work in a matrixed team environment.
- Ability to coordinate multiple priorities and meet established deadlines.
[job_alerts.create_a_job]
Computer Systems Validation Specialist • Triangle, NC
[internal_linking.similar_jobs]
The Senior Validation Engineer is a subject matter expert in the Commissioning and Qualification program and provides leadership and mentorship in the qualification of equipment, utilities, and pro...[show_more]
Title: Senior Systems Admin - Z/OS.Role will be upgrading, 3rd party, Mainframe, patching, working w/ DBAs.If interested please send your updated resume to.If you know of anyone in your sphere of c...[show_more]
Information Technology-SOM-420401.Is this an internal only recruitment?:.Technology Support Analyst - Journey.Full-time/Part-time Permanent/Time-Limited:.To learn more about the pay band for this b...[show_more]
We require the skills of a Controls Test Engineer who is knowledgeable of PLC design and State Machine Controls Software.BD is one of the largest global medical technology companies in the world.Ad...[show_more]
The Director, Clinical Systems owns the Systems' solution architecture, interoperability, governance, and performance of Velocity's clinical technology ecosystem - including but not limited to CTMS...[show_more]
Once an aircraft launches off a carrier, pilots depend on their jet's complex electronic systems to operate all areas of their craft and complete their mission.There is zero room for failure.That's...[show_more]
Primarily responsible for ensuring adherence to computer validation standards and procedures for computer related systems.Responsibilities include participation in system design, preparation of tes...[show_more]
Senior Systems Analyst This Jobot Job is hosted by: Adrionna Roy Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Salary: $140,000 - $140,000 per year A b...[show_more] Viral Vector Core Director - Open Rank.Dependent on Experience and Qualifications.A global higher education leader in innovative teaching, research and public service, the.University of North Carol...[show_more] 
We have an exciting opportunity fora.Senior Standards Project Specialist (Fast-Track).This is a hybrid opportunity based in one ofour office locations:Ottawa, CAN; Evanston, IL; Raleigh-Durham, NC....[show_more]
We require the skills of a Controls Test Engineer who is knowledgeable of PLC design and State Machine Controls Software.BD is one of the largest global medical technology companies in the world.Ad...[show_more]
Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world.We leverage our proprietary computational ...[show_more]
Information Technology Professional (IT/CTN/IS).Information Systems Technicians, Cryptologic Technician Networks, and Intelligence Specialists keep the Fleet connected, informed, and secure by oper...[show_more]
Position Summary: The Associate Clinical Sales Specialist is specifically responsible for obtaining and maintaining expert knowledge of Stryker Joint Replacement product portfolio including the Mak...[show_more]
At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community.No matter where your talents lie, join us and disc...[show_more]
Competitive weekly pay (inquire for details) .AlliedTravelCareers is working with Lancesoft Inc.CT Tech in Chapel Hill, North Carolina, 27514!.We are currently seeking qualified candidates for CT T...[show_more]
Job Description Job Description Addiction Specialist - ACT Team Full-Time | Cambridge, MD & Salisbury, MD Schedule: Monday-Thursday 36 hour, 4-Day Work Week Salary Range: $40,000-$55,000 annually P...[show_more]
Senior Validation Engineer (CSV), Biotechnology - (JP15063).Only qualified candidates need apply.Standard Working Hours 8:00AM - 5:00PM.Senior Validation Engineer (CSV), Biotechnology.Primarily res...[show_more]
Senior Validation Engineer
Novartis Group Companies • Durham, NC, United States
[job_card.full_time]
[last_updated.last_updated_1_day] • [promoted]
Senior Systems Admin - Z/OS
Two95 International Inc. • NC, US
[filters.remote]
[job_card.full_time]
[filters_job_card.quick_apply]
[last_updated.last_updated_30]
Technology Support Analyst
InsideHigherEd • Chapel Hill, North Carolina, United States
[job_card.full_time] +2
[last_updated.last_updated_variable_days] • [promoted]
Control Systems Engineer/Robotics Test Validation
Becton, Dickinson and Company • Durham, NC, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Director, Clinical Systems
Velocity Clinical Research, Inc. • Durham, NC, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Aviation Electronics, Electrical & Computer Systems Technician
US Navy • Durham, NC, United States
[job_card.part_time]
[last_updated.last_updated_variable_days] • [promoted]
Validation Engineer Senior
Varite • Holly Springs, NC, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Senior Systems Analyst
Jobot • Durham, NC, US
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Viral Vector Core Director - Open Rank
InsideHigherEd • Chapel Hill, North Carolina, United States
[job_card.full_time] +3
[last_updated.last_updated_30] • [promoted]
Senior Standards Project Specialist (Fast-Track)
ULSE • Durham, NC, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Control Systems Engineer/Robotics Test Validation
Becton Dickinson & Company • Durham, NC, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Manager, QA Validation (Contractor)
Kriya Therapeutics • Research Triangle Park, NC, US
[job_card.full_time]
[filters_job_card.quick_apply]
[last_updated.last_updated_30]
IT Support Specialist
U.S. Navy • Fearrington Village, NC, US
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Associate Clinical Sales Specialist (A.CSS)
Crosslink • Timberlake, NC, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
COMPLIANCE SPECIALIST
Dukehealth.org • Durham, NC, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Travel CT Tech in Chapel Hill, NC
AlliedTravelCareers • Chapel Hill, NC, US
[job_card.full_time] +1
[last_updated.last_updated_30] • [promoted]
Addiction Specialist
HealthPort • Cambridge, Maryland, US
[job_card.full_time]
[last_updated.last_updated_1_day] • [promoted]
Senior Validation Engineer (CSV), Biotechnology
3 Key Consulting • Holly Springs, NC, United States
[job_card.permanent]
[last_updated.last_updated_variable_days] • [promoted]