We invite you to join our growing team! Are you a Validation Engineer with hands-on experience in a pharmaceutical fill/finish environment looking for an opportunity to make a real impact on global health and wellness? We are seeking a highly motivated Senior Validation Engineer with strong validation expertise — including cleaning validation — to join our team and support our sterile injectables manufacturing facility. This is a key individual contributor role within our Validation Department, responsible for understanding and implementing validation requirements across a fast-growing CDMO (contract development and manufacturing organization) serving parenteral injectable drug clients. About Us We're more than a contract development and manufacturing organization — we're a company built on the idea that there's always a better way: a better way to work with our customers, a better way to build meaningful experiences, and a better way to create a culture where everyone can thrive. Join us in building a new world-class CDMO for parenteral injectable drugs and help shape the future for yourself, our clients, and their patients. Our Values (ALP): All IN

• Patient impact, positive attitude, and a company committed to your growth Lean Forward
• Bias for action, service-centric, solution-oriented, ready for challenging projects Pull for the Team
• Customer success first, respect for others, celebrating wins together What You'll Do Perform qualification activities on utilities, equipment, and laboratory systems used in a fill/finish environment, including clean utilities, autoclaves, washers, fillers , laboratory instruments, and controlled temperature units Develop, execute, and own cleaning validation protocols and programs to ensure equipment and facility compliance with cGMP standards Interact directly with clients to provide validation support, including product launch support and new equipment qualifications Provide validation oversight for capital expansion projects and facility build-outs Author and revise SOPs, work instructions, and guidelines for equipment and cleaning validation policies, standards, and templates Review facility and process changes and determine re-validation/re-qualification needs Assess risk in processing steps related to equipment and develop or review validation requirements and design deliverables Partner cross-functionally with Engineering, Operations, and Quality to support validation and continuous improvement efforts Execute validation qualifications in accordance with approved protocols and identify/document protocol excursions Track industry trends and regulatory expectations for cleaning and equipment validation, proposing program updates to stay current

What You Bring Required:

Bachelor's degree or higher in a STEM discipline 5-8 years of experience in validation or a related discipline 4+ years of GMP experience in the pharmaceutical industry , with direct experience in a fill/finish (sterile injectables/parenteral) manufacturing environment Demonstrated hands-on cleaning validation experience Ability to influence outcomes cross-functionally without direct reporting authority Physically capable of working onsite

Preferred:

Master's degree or higher Computer System Validation (CSV) experience VHP (Vaporized Hydrogen Peroxide) and steam sterilization experience Why Join Us? Paid vacation (based on tenure) and paid sick time 11 observed holidays 401(k) with company match up to 3.5% of salary, vested immediately Choice of health & wellness plans FSA and HSA programs Dental & vision coverage

Pay:

$95,000.00

• $130,000.

00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Relocation assistance Vision insurance

Work Location:

In person