The role
You will prove that equipment, systems and processes do what we say they do — with evidence a regulator would accept.
What you will do
- Author and execute validation protocols for equipment, utilities and processes
- Manage requalification schedules and periodic review
- Support commissioning and qualification of new capital projects
- Investigate and resolve validation discrepancies
- Maintain the validation master plan and associated documentation
What success looks like at 12 months
Your protocols execute with minimal discrepancies, requalification is never late, and a project has been qualified on your documentation without a finding.
What we require
- Engineering or science background, or equivalent technical experience
- Understanding of qualification lifecycle and GMP expectations
- Strong technical writing
- Onsite role supporting an operating plant
What we would like, but will teach you
- Process validation or CSV experience
- Capital project commissioning experience
- Experience of a regulatory inspection covering validation
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.