Validation Engineer – Merrimack Pharmaceuticals – Cambridge, MA, USA
Merrimack is a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of cancer. Merrimack seeks to gain a deeper understanding of underlying cancer biology through its systems biology-based approach and develop new insights, therapeutics and diagnostics to improve outcomes for cancer patients. Merrimack currently has six oncology therapeutics in clinical development and three additional candidates in late stage preclinical development. Merrimack’s lead product candidate, MM-398, recently completed a Phase 3 trial in post-gemcitabine pancreatic cancer. Based on the results of this trial, Merrimack has recently submitted a New Drug Application for MM-398.
We are looking for a talented Validation Engineer to join our team that is willing to contribute, learn and grow! The Validation Engineer will be responsible for executing facility, clean utilities, automation, computer systems, processing equipment, and cold chain/shipping validation and revalidation activities at Merrimack Pharmaceuticals.
Write, review, execute and summarize validation protocols and summary reports as applicable to GMP Facilities, Utilities, Automation/Computer Systems, Equipment and Shipping Systems
Manage external contractors, and third party vendors for validation projects
Provide technical input in determining strategy for validation activities
Represent validation during site GMP activities and participate on cross-functional teams
Act as validation representative on change control committees and provide validation input on Quality Systems such as Quality Incidents & CAPAs
Assist in managing and trouble-shooting plant-wide building monitoring / alarming systems
A minimum of a BA or BS, preferably in Life Sciences, Engineering, Math or Chemistry or other job-related discipline.
A minimum of 5 years of related experience in validation, including equipment, within a pharmaceutical, biotech, devices, or related industry
Experience using validation equipment such as temperature / RH monitoring devices, data acquisition systems, clean utilities, facility systems, process support systems, bioprocess manufacturing, and packaging equipment is desirable.
Experience with good documentation processes, cGMP, & FDA validation methods and systems, ability to read engineering documents, set priorities, and work on multiple projects simultaneously.
Strong verbal communication and technical writing skills.