Process Engineer - NPI, Tech Transfer

Description

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

Requirements

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.

• Bachelors of Sciences (BS) degree in engineering or chemistry (BS) with 3-5 years of relevant experience in a regulated GMP facility.
• 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.
• 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.
• Basic knowledge of cGXP requirements for pharmaceutical manufacturing and commercial/clinical supply required.
• Experience with GE/Cytiva Unicorn software is desired but not required.

Benefits

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.

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.

Training + Development

Interview process

Visa Sponsorship

Security clearance