Process Engineer (NPI/Tech Transfer)

About The Job

Arcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets.

We are more than 36,000 people, in over 70 countries, dedicated to improving quality of life. Everyone has an important role to play. With the power of many curious minds, together we can solve the world’s most complex challenges and deliver more impact together.

Role description:

Arcadis is seeking a seasoned Process Engineer to support a client in Norton MA. This role will own multiple aspects of clinical GMP tech transfer/new product introductions into the Norton site. In addition, they will act as the end user representative for engineering and validation projects and own manufacturing process improvement projects, as needed.

Role accountabilities:

• Perform manufacturing deliverables for New Product Introductions, including generation of mass balance, bill of materials, in-process sampling summary, and process fit analysis.
• Own New Product Introduction change controls and coordinate all required change actions to ensure completion prior to batch start.
• Work closely with other members of the manufacturing team to define documentation requirements for New Product Introductions and perform review & approval of those documents.
• Perform end user Manufacturing review & approval of equipment life cycle documents (DQ, URS, FS, CS, etc.), engineering test plans, and validation protocols/reports.
• Perform Manufacturing impact assessment and change action creation for change controls (in consultation with Manufacturing team’s SMEs and SOP/MBR owners).
• Support deviations/investigations, CAPA’s, and implementation of process & equipment related change controls.
• Identify and support implementation of continuous improvement projects to reduce cycle time, reduce COGS, and/or increase robustness.
• Collaborate with Manufacturing Operations, Process Sciences, Engineering, Quality Assurance, Quality Control, Validation, and others to support above responsibilities

Qualifications & Experience:

• Bachelors of Sciences (BS) degree in engineering or chemistry (BS) with 3-5 years of relevant experience in a regulated GMP facility. Minimum requirements may be substituted for the equivalent combination of education and/or experience in the industry.
• Basic knowledge of cGXP requirements for pharmaceutical manufacturing and commercial/clinical supply required.
• Must be able to work in cleanroom environment as needed.
• Experience with performing facility fit assessments for tech transfers/new product introductions is required.
• Experience with small molecule/oligonucleotides is desired but not required.
• Experience with GE/Cytiva Unicorn software is desired but not required.
• High level of attention to detail is required.
• Must possess excellent English communication skills.
• Strong organization and time management skills and ability to work independently as well as in a team setting are required.
• Ability to interact with department management and cross-functional stakeholders is required.

Why Arcadis?

We can only achieve our goals when everyone is empowered to be their best. We believe everyone's contribution matters. It’s why we are pioneering a skills-based approach, where you can harness your unique experience and expertise to carve your career path and maximize the impact we can make together.

You’ll do meaningful work, and no matter what role, you’ll be helping to deliver sustainable solutions for a more prosperous planet. Make your mark, on your career, your colleagues, your clients, your life and the world around you.

Together, we can create a lasting legacy.

Join Arcadis. Create a Legacy.

Our Commitment to Equality, Diversity, Inclusion & Belonging

We want you to be able to bring your best self to work every day which is why we take equality and inclusion seriously and hold ourselves to account for our actions. Our ambition is to be an employer of choice and provide a great place to work for all our people. We are an equal opportunity and affirmative action employer. Women, minorities, people with disabilities and veterans are strongly encouraged to apply. We are dedicated to a policy of non-discrimination in employment on any basis including race, creed, color, religion, national origin, sex, age, disability, marital status, sexual orientation, gender identity, citizenship status, disability, veteran status, or any other basis prohibited by law.

Arcadis offers benefits for full time and part time positions. These benefits include medical, dental, and vision, EAP, 401K, STD, LTD, AD&D, life insurance, paid parental leave, reward & recognition program and optional benefits including wellbeing benefits, adoption assistance and tuition reimbursement. We offer nine paid holidays and 15 days PTO that accrue per year. Salaries will vary and are based on several factors, such as experience, education, budget, internal equity, project and location.