Validation Engineer
Watertown, MA
Science and Technology Operations – Manufacturing /
Full Time /
On-site
Landmark Bio is dedicated to translating cutting-edge research into life-changing therapies. Headquartered in Watertown, Massachusetts, the company was founded by leading academic institutions, research hospitals, and industry partners to accelerate the development, manufacturing, and commercialization of advanced therapies. Driven by the compelling science and transformative potential of genetic medicine, Landmark Bio offers deep drug development expertise and integrated end-to-end solutions to support its partners. The company also serves as a collaborative platform to advance next-generation manufacturing technologies for novel modalities. Following its acquisition by Artis BioSolutions in 2025, Landmark Bio continues to operate as a distinct entity. Learn more at www.landmarkbio.com.
We are seeking a highly motivated and team-oriented professional with entrepreneurial spirit to join our company! This is an exciting opportunity for a well-qualified candidate to join a rapidly growing company focused on turning today’s cutting-edge research into tomorrow’s breakthrough therapies.
Provide support in implementing the Validation Program to support cutting edge technologies for cell therapy manufacturing, vector manufacturing, fill finish, and quality control testing for Landmark Bio’s Watertown site.
Responsibilities:
· Implement and support activities driven by a Validation Program and Validation Plans, including coordinating with third-party vendors and contractors, and ensuring Landmark Bio's analytical instruments, facilities, and equipment are qualified and maintained in a cGMP-compliant state.
· Support activities such as generation, review, and execution of validation documents related to the installation of new equipment and technologies for cell therapy manufacturing, vector manufacturing, fill finish, and quality control testing.
· Prepare, maintain, or review validation and compliance documentation, such as engineering change notices, schematics, or protocols.
· Develop, review, and execute documents related to the validation life cycle of facilities, critical utilities, temperature control units, analytical instruments and computerized systems while ensuring site’s successful adherence to the Validation Master Plan, and compliance with cGMP regulations, guidance, and industry standards.
· Plan and coordinate the validation/qualification work assigned, including Validation Plans, Specifications, Qualification protocols, Summary Reports, etc.
· Partner closely with colleagues in Process Development, Manufacturing and Quality Control assisting with establishing business and compliance requirements of instrumentation and processes.
· Provide validation support associated with change controls, work orders, and new projects by applying technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant SOPs.
Minimum Requirements:
Bachelor's degree in Engineering Management, Biomedical Engineering or a closely-related field plus 3 years of experience in a Qualification/Validation role in a biotechnology or related field (i.e. pharmaceutical/medical device) manufacturing environment, or in the alternative, a Master’s Degree in Engineering Management, Biomedical Engineering or a closely-related field plus 1 year of experience in a Qualification/Validation role in a biotechnology or related field (i.e. pharmaceutical/medical device) manufacturing environment.
Experience, which may have been gained concurrently with primary requirement above, must include 1 year of:
· Preparing qualification or validation studies of Facilities, Utilities, TCU’s, Analytical instruments, or Computerized systems.
· Maintaining and reviewing validation and compliance documentation.
· Using Kaye Validator, Ellab, Microsoft Word and Excel software.
· Working with regulatory requirements (FDA, EMA, ICH, etc.) and industry standards (GMP, GLP, GAMP, etc.) related to CQV.
· Working with risk assessment methodologies (e.g., FMEA) and root cause analysis.
Must possess working knowledge of cGMP requirements including Validation Program requirements.
Position may require the ability to lift materials up to 20 lbs., dexterity to gown, and mobility to maneuver around equipment.
This is an on-site position, with up to 10% remote work from a home office within normal commuting distance of Watertown, MA permitted.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability.
Landmark Bio is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.
