Job Title and Overview: Computer Systems Quality Assurance

Reporting to the NIS Quality Leader, the Computer Systems Validation (CSV) Engineer will be responsible for computer systems validation activities at NIS, as well as providing backup cover for the Quality Leader. As well as having the primary responsibility for Computer System Validation, the job holder will also become familiar with all of NIS quality systems.

The job holder will contribute to the development, execution, and continued optimization of NIS’s CSV guidelines and procedures, which will underpin the validation of the facility’s various software systems and their ongoing connectivity. The role is key to ensuring the compliance of the facility’s quality, manufacturing, and engineering systems with current GxP and GAMP5 requirements.

The first priority for this new role will be the ongoing validation of the NETTE, and Appion systems, and provide ongoing validation support for NIS developed automation used for the analysis of characterization samples. In addition, there will be the requirement to oversee the further integration of these systems with the companies QMS systems and their validation, and an ongoing responsibility for qualification of all GMP hardware and software systems as they come on board.

Reports to: NIS Quality Leader

Responsibilities:

• To maintain consistent and documented compliance with all relevant Good Manufacturing Practice (GMP), Data Integrity (DI), quality and best practice requirements.
• To identify and document computer systems which impact upon GxP and aid in the performance of the validation of identified systems at NIS.
• Hold expertise in validation procedures and performance in line with GAMP5 guidance and how this is applied to highly complex automated systems.
• Oversee the installation and software testing processes planned for the install at NIS and provided by vendors.
• Manage the validation full lifecycle of the NIS software systems ensuring that they operate in compliance with GxP/ GAMP5 requirements.
• Author and support others in the generation of the lifecycle CSV deliverables for each computer system, including validation plans, risk assessments, software testing, summary reports, configuration testing and change control.
• Maintain appropriate validation documentation and files according to cGMP and CPI validation policies and procedures.
• Act as change owner for all digitally connected GxP systems within the facility, tracking changes through to completion, identifying risk and preparing mitigation plans.
• To provide technical guidance in CSV approaches and documentation to NIS, supporting these programs. Predicting and resolving issues / differences of opinion and style as they arise.
• To proactively support line management and the rest of the management team in the execution of their responsibilities.
• To provide regular, accurate and timely reporting of progress to the project sponsors and stakeholders.
• Take on the role of Subject Matter Expert during internal and external audits of the CSV lifecycle plans and validation documentation.
• When necessary, be able to provide backup cover for the NIS site quality leader.

Job Requirements:

● Bachelor’s degree in computer science or related technical fields, or equivalent professional technical experience in information technology

● Five or more years designing, implementing, maintaining, and documenting hardware, software and network computing systems in a pharmaceutical or life sciences company.

● Proven strong troubleshooting skills in information technology applications.

● Experience with client and or regulatory agency inspections. (FDA,EMA, ANVISA).

● Willingness to learn quickly and adapt to changes.

● Self-motivated and ability to excel in a fast-paced, collaborative environment.

● Excellent verbal and written communication skills.

Job Type: Full-time

Pay: $90,000.00 - $130,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Compensation package:

• Performance bonus

Experience level:

• 5 years

Schedule:

• Monday to Friday

Work Location: In person