[ref. k49352522] Process Engineer I

Overview:

Be Seen and Heard at EyePoint Pharmaceuticals

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.

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 role is based in our Watertown, MA office.

Responsibilities:

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

• Ability to support engineering related projects to continuously review and revise processes in production to enhance quality, yield, and efficiency.
• Author and execute equipment commission and qualification protocols and reports.
• Support project planning and improvements to reduce cost and increase efficiency.
• Coordinate and communicate engineering related activities with product vendors and suppliers.
• Contribute to the design, development, and optimization of processes, including upstream and downstream operations.
• Troubleshoot process-related issues and contribute to quality investigations and implementation of corrective action.
• Create, customize and implement tooling and fixturing to increase efficiencies and product quality in manufacturing.
• Write development protocols, testing protocols, validation protocols and final reports.
• Generate and maintain process documentation, including standard operating procedures, work instructions, and batch records.
• 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.

Qualifications:

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 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.
• Familiarity with engineering software like AutoCAD and SOLIDWORKS.
• 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 1-2 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.

Transformational Innovation

We exist to change our patients’ lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology.

Unwavering Integrity

We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us.

Compassionate Excellence

We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes.

Inclusive Collaboration

We strive to see through the eyes of others and work as one team. We appreciate one another’s differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward.

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.

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