Sr. Validation Software Specialist

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:

• Provide quality oversight over the validation and qualification activities for computer systems

and processes to support both clinical and commercial requirements in a GMP environment

• Provide quality oversight on GXP computerized systems implementation and coordinate with

the Software Validation team to complete validation activities

• Provide oversight and review of qualification and validation activities including review and

approval of qualification protocols, reports, retirement, and any associated documentation in

support of computer systems validation and data integrity of computerized systems

• Reviews master and completed computer system(s) qualification and validation protocols,

summary reports and associated data for conformance to regulations, SOPs, specification,

and other applicable acceptance criteria

• Review and approve change controls, SOPs, deviations, and CAPAs associated with

qualification/validation execution and ensure effectiveness of related actions

• Provide expertise and solutions to issues regarding Software Quality Management and

Software Development Life Cycle (SDLC) strategies and documentation

• Provides guidance on industry best practices, and quality requirements for maintaining a

compliant state for all site systems

• Facilitates and collaborates in the development of computer system related policies, SOPs,

procedures, templates, and forms

• Develops and evaluates quality processes and system standards to ensure compliance with

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

• Interacts with Business System Analysts, Software Validation Specialists, other Quality and

Technical positions proactively to assess, and guide in the deployment of Computerized

systems

• Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP

requirements

• Develops CSV Gap Assessments and Remediation Plans with an understanding of applying

risk management principles

• Communicate all identified compliance and quality risks to his/her supervisor and all

appropriate parties

• Supports regulatory and client audits as CSV subject matter expert

• Drive continuous improvement

• Other duties as necessary

Regulatory Compliance

• Follow applicable regulatory requirements (GMP, GLP, ISO, etc.)
• Follow company policies and procedures

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

• Strong knowledge of GxP compliance as it applies to Computer Systems, 21 CFR Part 11, EU

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

• Knowledge of expectations on IT Cloud compliance requirements and emerging industry

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