- Work with QA management in development and implementation of efficient software/computer validation program for GLP environment
- Identify computerized systems validation needs through in-house assessments or by coordinating needs assessments to be conducted by external team
- Partner with business and validation team for site computer validation projects
- Development of Software/Computer validations protocols and final reports as well as to coordinate and perform activities per protocols
- Maintain site Master Validation Schedule and periodic review of validated systems.
- Assist QA in the process of auditing vendors of cGMP related software and hardware.
- Evaluate Vendor validations, adding company specific protocols as required to complete validation
- Provide technical council on issues and concerns regarding validation plans and protocol designs. Provide input on the design of the specifications and/or functional specification requirements for equipment's facilities and systems
- Train company as needed on SOPs
- Other duties as assigned
- Minimum: bachelors or equivalent
- Experience: 5-10 years' experience in Computer System Validations
- Knowledge of GxP
- Level of proficiency necessary for competence in the position as identified by the department training website
- Knowledge of GLPs (21 CFR Part 11) and other federal regulations relating to information technology
- Advanced understanding of laboratory operations and data collection
- Ability to work effectively under time constraints
- Adaptability/Flexibility
- Conflict Resolution
- Critical Thinking
- Resilience
- The person filling this position will spend approximately 80% in an office setting and 20% in the laboratory. There will be exposure to animal pathogens and chemicals. There will be handling of, and/or exposure to animal tissue and zoonotic organisms.
- Ability to don and wear personal protective gear, including N95 masks and respirators.
- Physical requirements: Ability to lift and carry up to 50lbs. Occasionally ascend/descend ladders and stairs.
- Ability to work beyond typical work schedule including but not limited to evenings, weekends, extended shifts with short notice.
-
Computer Validation Specialist
2 weeks ago
Piper Companies Spring Lake, United StatesPiper Companies is seeking a Computer Validation Specialist to join a contract research organization located in Spring Lake, MI. · Responsibilities of the Computer Validation Specialist include: Work on development and implementation of validation programs for GLP environment, ...
-
Computer System Validation Specialist
3 weeks ago
Medix Norton Shores, United StatesPosition Summary · The Computer Validation Coordinator (CVC) will play a pivotal role in orchestrating validation initiatives for computer systems, both hardware and software, with a particular focus on laboratory environments, ensuring the integrity of processes. Responsibilitie ...
-
Computer System Validation Specialist
3 weeks ago
Medix Muskegon, United StatesPosition Summary · The Computer Validation Coordinator (CVC) will play a pivotal role in orchestrating validation initiatives for computer systems, both hardware and software, with a particular focus on laboratory environments, ensuring the integrity of processes. Responsibiliti ...
-
Computer System Validation Specialist
1 week ago
Northern Biomedical Research Norton Shores, United StatesRole Summary · The Computer Validation Specialist (CSV) will be engaged in coordinating validation efforts for computer systems, hardware and software, especially in the lab setting, to ensure process quality. The CSV Specialist responsibilities include managing computer validat ...
-
Validation Specialist Perrigo Holland
4 weeks ago
OSI Group Holland, United StatesPerrigo Company plc, a leading global healthcare company, delivers value to its customers and consumers by providing Quality Affordable Healthcare Products. Founded in 1887 as a packager of home remedies, Perrigo has built a unique business model that is best described as the con ...
-
Sr. Validation Engineer or Specialist
3 weeks ago
Grand River Aseptic Manufacturing Grand Rapids, United StatesQuality, Service, Collaboration, Courage. Do you exhibit these values and wish to be around others that do too? Are you interested in making a difference in your community and the world? Are you looking for a place where you can grow and learn in a diverse, community-minded cultu ...
-
Auto Technician
1 week ago
Global Autoworks Grand Haven, United StatesAre you passionate about cars and skilled in diagnosing and repairing premium vehicles? Imagine industry-leading pay as a full-time Auto Technician - C Level, with fantastic benefits, and no weekend work · Pay: $25 - $30 per hour, depending on experience, plus bonus program · Ben ...
-
Automotive Technician
2 weeks ago
Global Autoworks Grand Haven, United StatesJob Description · Job DescriptionAre you passionate about cars and skilled in diagnosing and repairing premium vehicles? Imagine industry-leading pay as a full-time Automotive Technician - Auto Mechanic, with fantastic benefits, and no weekend work · Pay: $60,000 - $80,000 per ye ...
-
convenience store lead
1 week ago
D&W Fresh Market Grand Haven, United StatesAt SpartanNash, we deliver the ingredients for a better life through customer-focused innovation. We do this for our supply chain customers and U.S. military commissaries, retail store guests and, most importantly, our Associates. In fact, we see a day when each will say, "I can ...
-
Sr. CSV Engineer
2 days ago
Cognizant Fruitport, MI, United StatesSr CSV Engineer Cognizant Technology Solutions in LSMG is seeking for a Sr CSV Engineer who could join our team of Engineering professionals in a permanent role. Our strength is built on our ability to work together. Our diverse set of backgrounds offer different perspectives and ...
-
Engineer I
2 days ago
Cognizant Fruitport, MI, United StatesSr CSV Engineer Cognizant Technology Solutions in LSMG is seeking for a Sr CSV Engineer who could join our team of Engineering professionals in a permanent role. It encourages lively discussions, inspires thought leadership, and helps us build better solutions for our people and ...
-
Automotive Customer Consultant
3 weeks ago
Preferred Ford Grand Haven, United StatesProduct Specialist · Is this the right opportunity for you? · Preferred is looking for the right person to teach and grow as a Product Specialist. We provide an excellent training program to help you build a career in the auto industry. The right person will be motivated, outgoin ...
-
Shipping, Receiving
4 weeks ago
RAMI Grand Haven, United StatesJOB SUMMARY · The Shipping, Receiving, and Inventory Specialist is responsible for tracking inventory, keeping accurate records, packaging, and weighing items, printing shipping labels and postage, inspecting goods received for damage, and distributing products to other departmen ...
-
Fleet Mechanic
3 weeks ago
DTE Energy Muskegon, United States** Fleet Mechanic - Transportation Leader - Muskegon** · Location: Muskegon, MI, US · Company: DTE Eng Corp Svcs LLC Job ID: 7834 DTE is one of the nations largest diversified energy companies. Our electric and gas companies have fueled our customers homes and Michigans progres ...
-
Environment, Health and Safety Manager
3 days ago
La Colombe Coffee Roasters Muskegon, United StatesThe selected candidate will provide overall leadership for the environmental, safety and health programs for the entire La Colombe organization that includes: 3 Manufacturing locations (Norton Shores MI, Tioga St and Solmon ST in Philadelphia, PA), warehouses, sales offices and 3 ...
-
Experienced Floorcare Specialist
2 days ago
West Michigan Janitorial Grand Rapids, United States Full time· Experienced Floorcare Specialist · We are actively recruiting for a floor care specialist. This person will report directly to the floorcare manager. The responsibilities include using using a ride-on floor cleaner. Experience is preferred but we are willing to train the right ...
-
HVAC Specialist
3 weeks ago
Brio Living Services Grand Rapids, United States Full time 30-40 HOURS/WEEKHVAC Specialist · Status: Full – Time, 40 hours per week · Schedule: M-F 8:00 - 4:30. On call for emergencies during weekends. · Porter Hills Village | Environmental Services · Req#: 8239 · Why Brio Living Services? · Make a real impact in the lives of older adults · Medical, ...
-
Bilingual Youth Development Specialist
1 week ago
Bethany Christian Services Grand Rapids, United StatesBilingual Youth Development Specialist · Requisition # : req13296 · Location: Grand Rapids, MI · Hours: Full-time (40 hours/week) · Bethany is changing the world through family. We began our work by serving one child more than 75 years ago. Today, Bethany is an international C ...
-
Reset Specialist
1 week ago
Columbia Distributing Kent, United States Full timeWorking Locations · KentPay Range · $ $22.50/hrJob Details · Summary · Reset specialists play a critical role at Columbia Distributing, working with Sales Teams and Retail Partners to set schematics and execute resets. Additionally Reset Specialists assist Sales teams with a wid ...
-
B2B Water Specialist
4 days ago
Culligan Kaat's Water Conditioning Grand Rapids, United StatesB2B Water Specialist · Here at Kaat's Water Conditioning, Inc. · dba Culligan, we are continually growing and are in need of a Sales Representative for our innovative bottle less water purifier. · This person is responsible for developing new customers and maintaining relationsh ...
Computer System Validation Specialist - Spring Lake, United States - Northern Biomedical Research Inc
Description
Job Description
Job DescriptionRole Summary
The Computer Validation Specialist (CSV) will be engaged in coordinating validation efforts for computer systems, hardware and software, especially in the lab setting, to ensure process quality. The CSV Specialist responsibilities include managing computer validation project activities and creating computer system planning documents and testing protocols. The position is also responsible for reviewing test results and identifying areas for improvement and implementing changes. Other duties include providing technical expertise to team members and other departments while communicating the validation plan and creating protocols. This position is responsible for ensuring the systems and process are compliant with GxP, GAMP and Code of Federal Regulations.
This is an exempt position with no supervisory responsibilities. This person can sit at either our Norton Shores or Portage, MI location.
Role Responsibilities
Role Requirements
Behavioral Expectations
Special Requirements
