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 to develop new insights, therapeutics and diagnostics to improve outcomes for cancer patients. Merrimack has multiple oncology therapeutics in clinical development and additional candidates in late stage preclinical development. Merrimack has submitted a New Drug Application for its lead product candidate, MM-398.
The Validation Engineer will be responsible for executing cleanroom HVAC facility, clean utilities, automation, processing equipment, and cold chain/shipping validation and revalidation activities at Merrimack Pharmaceuticals. We are looking for someone who is willing to contribute, learn and grow! This position will primarily support our nanoliposomal manufacturing facility, warehouse and supply chain department.
Job Responsibilities:
- Write, review, execute and summarize validation master plans, project plans, protocols and summary reports as applicable to Cleanroom HVAC Facilities, Utilities, Automation Systems, Manufacturing Processing Equipment
- 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 GMP equipment management program including calibration, maintenance and building monitoring systems, as needed
Requirements:
- 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.
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