The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year.
Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.
Job summary:
The IT Software Validation Specialist position is responsible for developing, reviewing, and
executing validation documentation including Validation Plans/Reports, , Installation
Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ) and test results to maintain computerized systems and applications in a validated state.
Essential job functions:
- Design and implement validation deliverables / test plans and test cases, based on system understanding and analysis of user, functional and system specifications.
- Ensure new GxP software / computer systems and changes to existing systems are maintained in a state of control.
- Ensure accuracy and completeness of Software Development Lifecycle and/or IT Validation records (e.g., Validation Plan, IQ, OQ, PQ, Minor Change Record)
- Collaborate with business users and Business Analysts to understand user requirements and functional design specifications.
- Analyze test results and attach evidence to ensure acceptance criteria are adequately met; provide software QA approval to proceed with subsequent activities.
- Ensure test case failures or bugs are adequately investigated and resolved.
- Participate in release planning sessions to meet release schedule
- Ensure timely documentation of Protocol or minor change records and lifecycle documentation.
- Participate in process improvement efforts
- Perform other duties as assigned.
Regulatory & Compliance
- Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc.).
- Know and follow company policies and procedures.
Professional Development
- Complete required training on time.
Job requirements:
- Well versed with software lifecycle processes and methodologies, with an emphasis on quality assurance and testing best practices
- Proficient understanding of Pharmaceutical and Medical Device regulations including but not limited to 21CFR Part 11, 21 CFR Part 210/211, 21CFR Part 820, 21CFR Part 1271 and ISO 13485
- Demonstrated technical writing skills
- Working knowledge of MS Office applications
- Ability to multi-task and deal with changing deadlines
- Ability to troubleshoot complicated issues across multiple systems, regardless of architecture and driving the effort to a successful conclusion
- Ability to work with minimal supervision, managing own time effectively
- Demonstrated logic, problem solving, and decision making skills
- Regular and reliable attendance
Physical requirements:
- Must be able to stand/walk 10% of the day and 90% spent sitting at a desk or on the computer. Must be able to occasionally lift a minimum of 10lbs.
Education and experience requirements:
- BS degree in Engineering, Computer Science or Physical/Life Science; Associate degree or equivalent experience required.
- At least 2 years in a BA, QA, Laboratory or IT role
Sotera Health goes to market through its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries.
