The role
You will validate computerised systems — the evidence that software doing regulated work does it correctly.
What you will do
- Author and execute computer system validation documentation
- Perform risk assessments and define appropriate testing rigour
- Manage system change control and periodic review
- Support data integrity assessments and remediation
- Partner with IT and business owners on new system introduction
What success looks like at 12 months
Systems are validated proportionately and on schedule, data integrity gaps are closed, and validation is not the reason a project is late.
What we require
- Computer system validation experience in a regulated environment
- Understanding of GAMP principles and risk-based validation
- Strong technical documentation skills
- Ability to right-size validation rather than validate everything equally
What we would like, but will teach you
- Data integrity remediation experience
- Cloud and SaaS validation
- Manufacturing systems such as MES or historian
If you meet the required list, apply. We cap the preferred list at four items on purpose, and we would rather read an application from someone who is 70% there and hungry.
Hybrid — onsite at Bloomington, IN three days a week (Tuesday, Wednesday and one team-chosen day).
Pay and rewards
This role sits at grade 8, with a base range of $100,500 – $129,500 for this location, plus annual bonus, retirement contributions of up to 9%, and day-one benefits. See the full package.
About the site
Our drug product and sterile fill-finish site. More about our locations.
Accommodations
Need an adjustment to apply or interview? Email accommodations@ingenbiotech.example. It goes to a separate team and is never shared with the hiring manager. What we can arrange.
Applications are not enabled on this demonstration site
On a live InGen careers site this button would open a one-page application: a CV and three short questions, about twelve minutes, no account required and no cover letter.