Sotera Health Company Taylorsville , UT 84084
Posted 4 weeks ago
The Sr. Software Validation Specialist role is an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for computer systems and processes to support both clinical and commercial requirements in a GXP environment. This role with develop CSV gap assessments and remediation plan with an understanding of applying risk management principles. This role will also provide oversight of qualification and validation activities including data or document review and approval as needed. This role will be responsible for reviewing and approving qualification protocols, reports, and any associated documentation in support of computer systems validation, facility qualification, and data integrity for computerized systems as well as non-computerized systems. This role will support audits as the CSV subject matter expert and develop CSV gap assessments.
Essential Duties:
and processes to support both clinical and commercial requirements in a GMP environment
the Software Validation team to complete validation activities
approval of qualification protocols, reports, retirement, and any associated documentation in
support of computer systems validation and data integrity of computerized systems
summary reports and associated data for conformance to regulations, SOPs, specification,
and other applicable acceptance criteria
qualification/validation execution and ensure effectiveness of related actions
Software Development Life Cycle (SDLC) strategies and documentation
compliant state for all site systems
procedures, templates, and forms
applicable policies, industry standards, and global regulations
Assess equipment/systems for 21 CFR Part 11, GAMP 5 and Annex 11 requirements
Works with IT and global compliance partners to ensure configuration and documentation of
computerized systems to meet the requirements of CFR21 Part 11
Technical positions proactively to assess, and guide in the deployment of Computerized
systems
requirements
risk management principles
appropriate parties
Supports regulatory and client audits as CSV subject matter expert
Drive continuous improvement
Other duties as necessary
Regulatory Compliance
Competencies of this position
Strong interpersonal and written/oral communication skills
Ability to quickly process complex information and make critical decisions with limited
information
Ability to work independently and be responsible for a portfolio of ongoing projects
Ability to pay attention to details and follow procedures closely
Must be highly organized and capable of working in a team environment with a positive
attitude under minimal supervision
Detail oriented and flexible in a dynamic working environment
Strong proficiency with using Microsoft Office applications
Work Environment:
This job operates in a professional office and laboratory environment. This role routinely uses standard
office equipment such as computers and phones.
Travel requirements.
Occasional travel during the business day. Some out-of-the area and overnight travel may be
expected.
Physical requirements:
Must be able to stand/walk for 10% of the day and 90% of the day sitting at a desk or on the
computer.
Must be able to occasionally lift a maximum of 45lbs.
Education and experience requirements:
Bachelor's Degree in Computer Science or equivalent technical discipline
5+ years relevant work experience
Prefer experience working in a regulated facility, ideally in quality assurance, manufacturing
compliance, or clinical quality
Quality assurance experience in Pharma or Medical Device industry preferred
Knowledge of GxP regulations and FDA/EU guidance related to GMP manufacturing of
pharmaceuticals and/or preclinical biocompatibility assessments (FDA or OECD GLP) preferred
ANNEX 11, GAMP 5 Validation Lifecycle, Business Analysis and Computer Systems (ranging
from validated Excel spreadsheets, critical applications, software, IT infrastructure (hardware)
AUX1060 Rev 4
regulations and guidance (GAMP, OECD 17, OECD 22) or interest in becoming familiar
Experience in cGMP regulatory body audits
Experience reviewing/auditing GMP documentation
Ability to identify and assess possible gaps and work collaboratively to address such issues
Sotera Health Company