QAV Engineer

DPS Group Global; Boston (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Arcadis is seeking an experienced QAV Engineer to support a pharmaceutical client in the Boston area. You will contribute to quality engineering activities across qualification, validation, and remediation within GMP environments.

Ideal candidates have a Bachelor’s degree in Engineering or Science, 3+ years in GMP manufacturing, and hands-on experience with IQ/OQ/PQ, CAPAs, change control, and regulatory guidance (FDA, cGxP).

Qualifications

• Bachelor’s degree or equivalent in Engineering, Science, or related discipline.
• 3+ years of experience working in a GMP manufacturing facilities role.
• Must have Oral Solid dosage expeience.
• Experience in pharmaceutical or biopharmaceutical/biotechnology cGxP environment.
• Combination of equipment qualification, process validation, computer systems, cleaning, and sterilization is acceptable. QA pharmaceutical experience is also preferred.
• Quality experience with in-depth knowledge of Validation approach, cGxP standards, and Risk-based validation.
• Must have direct experience in the commissioning, qualification, and validation of facilities, utilities, production, laboratory, and support equipment.
• Experience working in cell and gene therapy products is a plus.
• Knowledge of Industry guidelines (ISPE, PDA) US and international regulations (FDA, cGMP, ICH, ISO, EMA) for validation of GMP facilities.
• Must have strong verbal, written, and interpersonal communication skills especially needed to work in a cross-functional environment.

Responsibilities

• Quality Engineering in the Pharmaceutical and/or Bio Pharmaceutical industries.
• Compliance review remediation to identified gaps.
• Initiate and Own CAPA’s to remediate gaps.
• Installation Verification, Functional Testing and Performance Qualifications (PQs).
• Ensure all aspects of cold storage, autoclave and warehouse validation adhere to required policies and procedures, including safety and training.
• Generate and execute validation protocols and assessments from a quality system documentation perspective for cold storage, autoclave and warehouse operations.
• Revision of Qualification and Validation life cycle documents.
• Assist in the investigation and remediation of Quality Events related to qualified equipment.
• Review lifecycle documents such as Impact Assessments, User Requirements, Design Documents, Risk Traceability Matrix, Criticality Assessments, Risk Assessments, Part 11 Assessments, etc.
• Review and Approve Validation plans, protocols, and reports.
• Assess Change Controls for Validation Impact.
• Collaborates with stakeholders, engineers, SMEs, and cross-functional team members in equipment qualification efforts.
• Participates in continuous improvement and validation maintenance efforts of GMP Documentation, including Batch Records.

Skills

Quality Engineering

CAPA management

Validation (IQ/OQ/PQ)

GMP compliance

Cross-functional collaboration

cGxP knowledge

Equipment qualification

Auditing

Documentation

Communication

Education

Bachelor's degree in Engineering or Science

Job description

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.

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

• Quality Engineering in the Pharmaceutical and/or Bio Pharmaceutical industries.
• Compliance review remediation to identified gaps.
• Initiate and Own CAPA’s to remediate gaps.
• Installation Verification, Functional Testing and Performance Qualifications (PQs).
• Ensure all aspects of cold storage, autoclave and warehouse validation adhere to required policies and procedures, including safety and training.
• Generate and execute validation protocols and assessments from a quality system documentation perspective for cold storage, autoclave and warehouse operations.
• Revision of Qualification and Validation life cycle documents.
• Assist in the investigation and remediation of Quality Events related to qualified equipment.
• Review lifecycle documents such as Impact Assessments, User Requirements, Design Documents, Risk Traceability Matrix, Criticality Assessments, Risk Assessments, Part 11 Assessments, etc.
• Review and Approve Validation plans, protocols, and reports.
• Assess Change Controls for Validation Impact.
• Collaborates with stakeholders, engineers, SMEs, and cross-functional team members in equipment qualification efforts.
• Participates in continuous improvement and validation maintenance efforts of GMP Documentation, including Batch Records.

Qualifications & Experience:

• Bachelor’s degree or equivalent in Engineering, Science, or related discipline.
• 3+ years of experience working in a GMP manufacturing facilities role.
• Must have Oral Solid dosage expeience.
• Experience in pharmaceutical or biopharmaceutical/biotechnology cGxP environment.
• Combination of equipment qualification, process validation, computer systems, cleaning, and sterilization is acceptable. QA pharmaceutical experience is also preferred.
• Quality experience with in-depth knowledge of Validation approach, cGxP standards, and Risk-based validation.
• Must have direct experience in the commissioning, qualification, and validation of facilities, utilities, production, laboratory, and support equipment.
• Experience working in cell and gene therapy products is a plus.
• Knowledge of Industry guidelines (ISPE, PDA) US and international regulations (FDA, cGMP, ICH, ISO, EMA) for validation of GMP facilities.
• Must have strong verbal, written, and interpersonal communication skills especially needed to work in a cross-functional environment.

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.