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 looking for an experienced QAV Engineer to work with a pharmaceutical client in the Boston, Seaport area. Ideal candidates should have a strong understanding of the engineering lifecycle related to biotech and pharmaceutical GMP industries.

Role accountabilities:

• Responsible for cGMP compliance of process, facility, utilities, equipment, method, and computer system validation and will be accountable for their execution across the Clients drug development ecosystem
• The role is responsible for ensuring the review and approval of all validation records and documentation (i.e equipment qualification, cleaning validation, and computer system validation) are compliant with in-house specifications/standards/procedures and Good Manufacturing Practices
• Provide QA oversight of commissioning, qualification, and validation activities
• Responsible for managing the review/approval of design and commissioning documentation, validation protocols (including associated discrepancies), reports and support records to certify compliance with specifications and procedures; ensures timely resolution of documentation, compliance, and quality system issues
• Reviews and assists in investigating discrepancies/deviations related to manufacturing process equipment, utilities, automation, computer systems, validation, methods, and laboratory instruments
• Responsible for performing change control assessments and reviewing/approving change control implementation plans for process, equipment, utilities, method, and computer system validation
• Participate in cross-functional meetings for planning and discussing changes to be commissioned, qualified, validated equipment/facilities/utilities
• Participates in continuous quality system improvements and supports implementing improvements in the GMP Validation and Change Control Programs
• Use critical thinking skills to partner with CQV and facility engineers to problem solve
• Other duties as assigned

Qualifications & Experience:

• Requires a Bachelor’s degree (engineering or scientific discipline)
• 3+ years of Life Science Industry experience preferred
• Quality assurance experience in the pharmaceutical industry providing Quality Assurance oversight 3-4 years with a BS degree
• Experience in IT systems, automation, operations, and manufacturing within the biotechnology industry and in new manufacturing facility startup environments is a plus.
• Excellent understanding of QA principles, industry practices, and standards with demonstrated ability to apply these to GMP operations. Ability to interact effectively with all levels of personnel within the organization.
• Ability to translate complex issues into a meaningful set of recommendations
• Demonstrated knowledge of cGMPs in a manufacturing environment
• Strong independent judgment and decision-making abilities
• Demonstrated problem-detection and problem-resolution skills
• Must possess demonstrated organizational skills
• Must possess excellent verbal and written

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.