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The Manager of Validation and Engineering will oversee and lead the design, development planning and implementation of equipment, utilities and computer systems validation for LFB USA, including requalification of existing systems and processes. The individual will work with staff and relevant departments to develop facility, equipment, computer system validation policies, protocol plans, protocols and standard operations procedures. This position will be responsible for meeting the project validation and engineering goals and adherence to requalification schedules. The process engineer IV will report to the Manager of Validation and Engineering. This position will be responsible for meeting project validation and engineering goals, and adherence to the requalification schedules. In addition, this individual will be responsible for monitoring and scheduling outside contractors for the required qualification of equipment.
The QA Associate Director, Compliance supports the optimization of the strategic direction for quality strategies, systems, policies, and procedures and manages the compliance training program which includes the implementation, optimization, maintenance, and assessment of company-wide training and management of support staff for a role-based electronically tracked training program as needed. In addition, this position will manage oversight for the vendor management program including maintenance of the Approved Supplier List, annual vendor reviews, and support companywide efforts to maintain acceptable levels of compliance with internal procedures, corporate requirements, and applicable regulations (i.e. FDA, EMA, etc. as applicable). The position will foster a collaborative environment and work closely with affected departments to ensure compliance by providing training modules, supporting inspections, assisting with internal audit program, product quality reviews, and key performance indicator trending.
Through collaboration with Manufacturing, Quality Control, Clinical Affairs, Facilities, and other operationaldepartments, maintains the company's training system, including creation and maintenance of role based curricula, optimization of the competency based on-the-job-training, and authoring/revising associated documentation.
The position is based in Framingham, with travel to Charlton as needed.
Primary function is the daily care and maintenance of the LFB USA rabbit colony used to produce pharmaceutical products.
Duties include basic animal husbandry, facility sanitization, animal restraint, feeding, milking, and record keeping.
Tasks must be carried out in accordance with Standard Operating Procedures (SOPs) and Work Instructions (WIs) and accurately documented to maintain compliance with FDA mandated Good Manufacturing Practices (GMPs). Additional duties as assigned.
The Process Engineer IV works in the Engineering, Validation & Metrology department and provides expert technical support to Commercial Operations at the Charlton, Framingham and Marlborough facilities. The Process Engineer will provide expertise in troubleshooting problems for manufacturing facilities and metrology functions. The Process Engineer will be responsible for the lifecycle management of various commissioning, qualification, and/or validation facets LFB-USA. In conjunction with other relevant departments, responsible for providing support for troubleshooting problems in manufacturing, specifies, orders and procures equipment used in manufacturing, performs the preparation of engineering and validation documentation for processes and equipment, initiates the production of batch documentation used for engineering and cGMP production.
The QC Analyst II is a strong support role for the activities of the QC Analytical laboratory - supports routine samples testing and all general laboratory functions.