Arcadis · 4 weeks ago
Process Engineer (NPI/Tech Transfer)
Norton, MA
Full-time
Onsite
Mid Level
3+ years expArcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets. They are seeking a seasoned Process Engineer to support a client in Norton MA, focusing on clinical GMP tech transfer and new product introductions while owning manufacturing process improvement projects as needed.
Civil EngineeringConsultingWater
Hiring Manager
Natalie Hebert
Responsibilities
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
Qualification
Required
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
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
Preferred
Experience with small molecule/oligonucleotides is desired but not required
Experience with GE/Cytiva Unicorn software is desired but not required
Benefits
Medical
Dental
Vision
EAP
401K
STD
LTD
AD&D
Life insurance
Paid parental leave
Reward & recognition program
Optional benefits including wellbeing benefits
Adoption assistance
Tuition reimbursement
Nine paid holidays
15 days PTO that accrue per year
Company
Arcadis
Arcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets.
10001+ employees
H1B Sponsorship
Arcadis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (126)
2024 (69)
2023 (69)
2022 (69)
2021 (72)
2020 (103)
Funding
Current Stage
Public CompanyTotal Funding
$0.03M2017-06-01Grant· $0.03M
1995-10-06IPO
Leadership Team
Alan Brookes
Chief Executive Officer
Neil McArthur
Chief Executive Officer
Recent News
2025-12-30
2025-12-25
Company data provided by crunchbase