What are the responsibilities and job description for the QAV Engineer position at Arcadis?
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 seeking a QAV Engineer in Boston, MA to Provide QA oversight of commissioning, qualification, and validation activities.
Role accountabilities:
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
Support review and approval of validation related documentation; including but not limited to: IA, URS, DQ, ERES, CDS/FRS, FMECA, IOQ
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
Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements
Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions
Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections
Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence
Other duties as assigned
Qualifications & Experience:
Bachelor’s degree or equivalent in Engineering, Science, or related discipline
3 years of experience working in a GMP manufacturing/ facilities role.
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.
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. 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.
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 seeking a QAV Engineer in Boston, MA to Provide QA oversight of commissioning, qualification, and validation activities.
Role accountabilities:
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
Support review and approval of validation related documentation; including but not limited to: IA, URS, DQ, ERES, CDS/FRS, FMECA, IOQ
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
Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements
Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions
Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections
Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence
Other duties as assigned
Qualifications & Experience:
Bachelor’s degree or equivalent in Engineering, Science, or related discipline
3 years of experience working in a GMP manufacturing/ facilities role.
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.
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. 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.
