Position Overview

The Validation Manager will act as a leader and be knowledgeable on all aspects of validation with responsibilities focused on Commissioning, Qualification and Validation (CQV) and Computer Systems Validation (CSV) supporting Beam’s Global GMP Operations. While the position is located at and focused on Beam’s Cambridge MA cGMP testing facility, the individual is expected to promote CQV program harmonization in support of all of Beam’s cGMP Operations. The role leads CQV/CSV on various technology development and implementation projects, which includes the creation, shop-floor execution, and close-out of various types of technical/validation activities and deliverables (e.g., validation project plans, protocols, risk/impact assessments, position papers) in support sustaining the Cambridge facility. These same functional support expectations can apply to support of Beam’s cGMP Manufacturing facility located in Durham, NC and may require on-site support (< 15%). The Validation Manager will provide oversight, lead execution and work cross-functionally and in project teams to determine the extent of validation required for the implementation of new assets, conduct impact assessments for proposed changes to existing assets, and be responsible for the execution of Beam’s re-qualification and validation maintenance programs.

The position demands deep knowledge and experience with validating Facilities, Utilities, Systems and Equipment (FUSE) and Analytical Instruments (AI) including those with embedded software systems. Further it is expected that the candidate has practical knowledge to apply data integrity concepts which are specifically tailored to both FUSE and AI. The Validation Manager will be a key member of the global validation organization which is a matrix of Beam FTE and contract personnel. The candidate must be adaptable to function as an independent contributor/SME and at times provide oversight to validation contract personnel. The position will report to Beam’s Validation Director.

Primary Responsibilities:

• Serve as a functional leader and SME for activities such as CQV, CSV, cleaning validation activities and other aspects of validation to ensure compliant operations.
• Responsible for maintaining the validation program, including policies, SOPs, plan(s), and others as required. This includes development, review, and shop-floor execution of validation documents and supporting packages.
• Support Validation Director as required in the overall coordination with contract validation firm(s) for all validation activities occurring throughout Beam’s global locations.
• Collaborate with all the GMP functions onsite and globally to provide continuous improvement of the validation program and support change management through review and assessment of changes.
• Provide status updates to management and others on the overall validation activities.
• Ensures cGMP principles are implemented and adhered to during execution of validation related activities and that FUSE/AI are compliant to all applicable regulatory guidelines and data integrity principles are adhered to.
• As assigned, compiles and reports data with appropriate interpretations for applicable management reviews, Annual Product Reviews, and all other required assessments.

Embodies Beam’s cultural values and aligns daily actions with departmental goals and company culture.

Qualifications:

• Bachelors or Advanced degree in a scientific discipline.
• 5-8 years experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality.
• 3-5 years of project management experience including support of large capital projects.
• Excellent verbal and written communication skills, detail-oriented personality, and ability to work and drive change across functions.
• Solid knowledge of global regulations and standards; experience interacting with regulatory health authorities at pre- and post-approval inspections is preferred.
• Experience with lifecycle management software, experience with Kneat preferred.
• Strong team player that has a customer service approach and is solution oriented.
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• Excellent team building, leadership, and management skills.
• Excellent listening, communication and interpersonal skills fostering team spirit.
• Consistent delivery of high-quality work at all times.
• Ability to gown and enter clean rooms (i.e. cGMP manufacturing spaces)
• Must be able to work onsite daily and willing to have a flexible schedule during peak times, which may include supporting critical operations outside of normal work hours, as needed.