Process Engineer I

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 worlds most complex challenges and deliver more impact together. Role description: Arcadis is looking for a Process Engineer I in Waltham, MA. This individual must have experience supporting clients in a cGMP environment. Role accountabilities: Installation and startup testing of new equipment (generation, execution, and close out of engineering test plans) Ownership of system P&IDs responsible for engineering review, walkdowns, redlines & system changes. Generation, review, and approval of engineering lifecycle documentation for assigned systems. Review, approval, and execution support of C&Q protocols for assigned systems. Generation, review, and approval of engineering change management for assigned systems. New systems troubleshooting floor support. This individual will work closely with Equipment SMEs, MS&T and equipment End Users to investigate and troubleshoot issues related to process equipment. Provide direct engineering support and Subject Matter Expertise for process equipment such as: (Ultrafiltration, Chromatography, TMIX, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, etc...). This includes serving as the Engineering owner for process equipment. Skills required to meet expectations of the role include high-quality technical writing within the required quality systems and meeting the project timelines to ensure the production schedule is not impacted. Provide daily, on-the-floor support to manufacturing. Facilitate tech transfer, process fit, and facility fit for new projects. Support the team goal of achieving gold standard batches and right the first-time processing. Troubleshoot equipment to determine root cause of failure modes, independently drive failure resolution, owning Corrective/Preventative Actions and associated change controls. Own quality records such as Change Controls, Deviations, and CAPAs, related to manufacturing process equipment, as required. Provide input into preventative maintenance plans, assessing change controls, and continuous improvement initiatives. Other duties as assigned Qualifications & Experience: 0-3 Years experience in a GMP manufacturing/engineering environment and a B.E. / B.S. degree in Chemical Engineering. Must have previous Biotech or Biopharmaceutical industry experience working in a process engineering role Must have strong knowledge and experience supporting cleaning (CIP, COP, glass washers, detergent distribution), sterilization (SIP, autoclaves), bench?top analytics (Cedex, Nova, filter integrity testers), and single?use systems. Good report and technical writing skills with the ability to drive changes in a cross-functional team environment Experience with all aspects of biotech and pharmaceutical industries. Demonstrates good interpersonal skills, is attentive and approachable. Maintains a professional and productive relationship with area management and co-workers. Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation. Why Arcadis? We can only achieve our goals when everyone is empowered to be their best. We believe everyone's contribution matters. Its 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. Youll do meaningful work, and no matter what role, youll 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.

Created: 2024-11-19