Our team is growing, and we are currently recruiting a Manufacturing Sciences and Technology (MSAT) Engineer I/II to support pharmaceutical operations at the Waltham and Watertown, MA sites. The focus of this position is to ensure manufacturing equipment and processes are operating as intended to meet the requirements for drug product manufacturing. This position will play a key role in delivering results in a fast paced, highly collaborative, and dynamic environment. The position will assist in the startup of a combination drug-device product from new product launch through commercial production. This involves process development, commercial process validations, technology transfers, as well as being accountable for commercial production.

Responsibilities

• Assist with the technical transfer of new processes into Lyra’s new Waltham facility by ensuring equipment specifications meet design requirements; ensure manufacturing equipment is appropriate to meet process and cleaning requirements
• Qualify and validate new equipment and/or processes to meet project deliverables; support creation of preventative maintenance plans for maintaining manufacturing equipment and assist with identification of spare parts required for maintenance activities
• Participate in authoring/editing new or approved GMP documentation such as SOPs, work instructions, and batch records
• Provide on-the-floor troubleshooting/technical assistance to manufacturing and quality operations for equipment and process-related issues. Responsible for identifying and mitigating manufacturing risk (i.e. spray coating, oven drying, packaging, etc.)
• Lead engineering-related Change Controls, Deviations, CAPAs, and continuous improvements.
• Author GMP change requests for implementation of changes to equipment, processes, and facilities
• Perform root cause analysis for deviation investigations and drive resolution of product/process issues
• Own and implement projects to address Corrective Actions / Preventative Actions (CAPA) identified as part of deviation investigations, customer requests, or GMP audits
• Monitor process health via Continued Process Verification and provide updates to the larger team as needed to understand process capability through Statistical Process Control systems

• Bachelor’s Degree (Engineering Preferred) with 1+ years of experience
• Hands-on experience and demonstrated organizational skills in a regulated GMP environment preferred
• Familiarity with IQ/OQ/PQ/PPQ principles and documentation preferred
• Previous experience with creating and revising process documentation and working in a cleanroom is required
• Ability to generate high quality data under tight deadlines, with a collaborative and proactive attitude
• Demonstrated ability to work well with cross-functional teams and to learn complicated concepts quickly and comfortably
• Ability to effectively communicate with internal and external team members as needed, to meet project deliverables
• Detail oriented, with strong computer and database skills

At Lyra, we value creativity, leadership, and collaboration.  The company sees significant expansion opportunities for our platform, and look for people who are driven to succeed, innovative, and adaptable.  We offer a competitive compensation and benefit package with opportunities to join a fast-paced, high performing team.  For consideration, please submit cover letter and CV.