Process Engineer I (Manufacturing) Northbridge, MA

Be Seen and Heard at EyePoint

At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we’re taking in business fuels our success for:

• preventing blindness through vision-saving medications
• delivering best-in-class proprietary pharmaceutical technologies
• transforming ocular drug delivery

We See You.

• Your wellbeing
• Your professional worth
• Your future at EyePoint

EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There’s space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected.

EyePoint is seeking a motivated Process Engineer I with excellent interpersonal skills to join our team. This person will be responsible for process sustaining and improvement of all components, device and packaging related projects. This position requires the application of continuous improvement, equipment oversight, trending, layout plans, testing, data analysis and report writing to resolve and improve manufacturing efficiencies. Candidate must be able to effectively collaborate with internal R&D, Quality, Regulatory and Operations departments and with external vendors and suppliers to deliver against project timelines and maintain process sustaining activities.

The ideal candidate possesses the ability to develop credibility and trust as a technical resource to contribute to the company’s growth, productivity, and innovation.

This position is located at our Northbridge, MA site and report to the Manager, Process Engineering.

Primary responsibilities include, but are not limited to, the following:

Individual responsibilities

• Coordinate and participate in sites continuous improvement initiatives aimed at enhancing product quality, improving operational safety, boosting operational efficiency, and minimizing waste.
• Author and execute development, testing, and validation protocols and final reports.
• Create or revise process documentation, including standard operating procedures, work instructions, and batch records.
• Troubleshoot process-related issues and support or lead as required failure investigations and implementation of corrective and preventative actions.
• Assist in training production associates on standard operating procedures and work instructions
• Collect and summarize in-process manufacturing data to support trending and statistical process control.
• Analyze development data and recommend new process development and/or changes to existing manufacturing processes.
• Create, customize and implement tooling and fixturing to increase efficiencies and product quality in manufacturing.
• Identify and qualify vendors for the procurement of production equipment or materials.
• Work in cross-functional teams and work with other departments for implementing change.
• Support GMP operations at the Northbridge, MA manufacturing plant on an as needed basis.

Primary skills and knowledge required include, but are not limited to the following:

• Excellent mathematical and statistical abilities as they will need to gather data and calculate optimal output. Familiarity with statistical analysis tools is a bonus.
• Familiarity with equipment, facility and process validations.
• Analytical skills to analyze process steps and seek optimization.
• Mechanical skills to oversee the use of equipment used in production.
• Experience in CAD platforms (SolidWorks/AutoCAD preferred).
• Proficient in Microsoft Applications (Word, Excel, PowerPoint, Visio)
• Strong commitment to compliance and ethical standards.
• Familiarity with cGMP regulations and quality management systems.

Other Requirements:

• Proactive and creative problem solver who is highly organized and detail oriented.
• Excellent listening and communication skills -both written and verbal.
• Ability to complete tasks within agreed timelines and resources through manager guidance.
• Adaptability, resiliency, and ability to thrive in fast paced organization.
• Ability to influence and drive organizational success.
• Strong project management skills; proficiency in tracking processes and projects.
• A demonstrated willingness to collaborate cross-functionally and build relationships.
• Experience in life sciences, medical devices, or regulated industry preferred.
• Ability to lift up to 25 pounds on occasion.
•  

Level of Education Required:  

• Bachelor of Science

Preferred Field of Study: Engineering

Number of Years of Experience in the Function and in the Industry:

• A minimum of 0-2 years of experience with equipment qualification and validation in the medical device and/or pharmaceuticals industry.

Envision Your Future

With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics.

The collective power of our values influences everything we do, and everything we do for you.

EyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

#LI-Onsite