Process Engineer II

Job Description

Wave Life Sciences (Wave) is a biotechnology company focused on delivering transformational therapies for patients with serious, genetically defined diseases. We differentiate ourselves through our proprietary chemistry platform that enables the production of stereopure oligonucleotides precisely targeting the underlying cause of rare diseases. At Wave, we welcome those who share a passion to change lives and embrace a culture that is thoughtful, dynamic, humble, and fearless. Together, we can contribute to our mission enabling every patient with a genetic disease to have access to life changing treatments.

Reporting to the Associate Director of Process Engineering, the Process Engineer is a key member of the team and will be responsible for the support of the GMP compliant clinical manufacturing facility in Lexington, MA. The successful candidate will also assist with oligonucleotide manufacturing, process scale-up, and problem solving with regards to equipment and systems. This is a cross functional role that will collaborate with and support various departments including Facilities, Process Development, Quality, Supply Chain and the CMC teams.

Responsibilities

Responsible for proper functioning and preventative maintenance of GMP equipment in the Oligonucleotide production plant.
Provide Engineering support to internal and external GMP manufacturing.
Draft and execute commissioning & qualification protocols for new equipment.
Lead equipment design changes per fit-for-purpose process requirements.
Develops and maintains P&IDs, PFDs, and mass balance documentation.
Leads troubleshoot efforts to address manufacturing equipment and utility system operating issues.
Drives quality systems including Change Controls, CAPAs, and Deviations / Investigations.
Support process validation efforts such as scale-down model verifications.
Utilize process modelling capabilities to evaluate plant capacity improvements, Debottlenecking and process improvements
Develop and implement novel process engineering solutions supporting new process equipment technology for Oligonucleotide manufacturing
Supports process scale up in collaboration with the Process Development and the MSAT teams.
Ensures adherence to Environmental, Safety, and GMP standards
May be responsible for design, project engineering, and / or project management relate to manufacturing system improvement

Education / Experience

Bachelors or Masters’ Degree in Chemical Engineering or a closely related discipline with 3-5 years of experience in a GMP/clean room manufacturing environment.
Working knowledge of methods and procedures used in the manufacture and quality control of APIs is required.

Skills / Pre-requisites

Working experience with API associated equipment.
Working knowledge of GMP manufacturing regulations.
Computer skills in Microsoft Office Suite including Project and Visio. Familiarity with CAD or similar P&ID developing tools and process modelling tools desired.
Highly motivated with good organizational and analytical/technical problem-solving skills.
Must be a self-starter with the capability to work independently under minimal supervision and work well in a team-based environment.
Strong written and oral communication skills.
Ability to climb ladders and work in tight spaces with equipment (bending, squatting, twisting)
Ability to lift objects of 25-50 pounds, push/pull objects, apply firm grasp and/or reach above shoulder height
Must be able to use personal cell phone for emergency team, as necessary

Throughout the global pandemic, Wave has been committed to ensuring the safety of all employees and their families, while continuing to move the business forward so that we can deliver on our commitment to patients. We have implemented an approach to COVID-19 that is informed by the science and aligns to recommendations established by the CDC and other applicable government health agencies. To that end, Wave has implemented a mandatory COVID-19 vaccination policy that requires its employees to be vaccinated to the maximum extent permitted by applicable law.

Wave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Wave Life Sciences’ employees to perform their job duties may result in discipline up to and including discharge.