The role
You will validate — cleaning, process, equipment and the periodic reviews that keep the qualified state qualified.
What you will do
- Author, execute and report validation protocols
- Manage periodic review and revalidation schedules
- Investigate validation deviations and assess impact
- Support new equipment and process introduction
- Maintain validation documentation to inspection standard
What success looks like at 12 months
Validation packages are approved with minimal comment, nothing is overdue for periodic review, and your documents are used as the site template.
What we require
- Validation experience in a GMP or comparable environment
- Strong technical writing and structured execution
- Understanding of qualification lifecycle principles
- Onsite role supporting operating areas
What we would like, but will teach you
- Cleaning validation experience specifically
- Statistical approaches to validation
- Experience defending validation in an inspection
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.
Onsite at Devens, MA. Site-based office roles are onsite three days a week; lab, plant and quality roles are onsite by nature.
Pay and rewards
This role sits at grade 7, with a base range of $95,500 – $123,000 for this location, plus annual bonus, retirement contributions of up to 9%, and day-one benefits. See the full package.
About the site
Our largest manufacturing site, running drug substance 24/7. 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.