Quality Assurance Validation Engineer
5 days ago
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.
-
Quality Assurance Engineer
1 month ago
Boston, United States Karen Clark & CO Full timeQuality Assurance Engineer Karen Clark & Company (KCC) seeks a Quality Assurance (QA) Engineer to join its software team in its beautiful Back Bay Boston office. The QA Engineer will help validate and test RiskInsight®, KCC's catastrophe modeling platform. The QA Engineer will help validate KCC's proven-accurate catastrophe models and software processes...
-
Quality Assurance Engineer
1 month ago
Boston, United States Karen Clark & CO Full timeQuality Assurance Engineer Karen Clark & Company (KCC) seeks a Quality Assurance (QA) Engineer to join its software team in its beautiful Back Bay Boston office. The QA Engineer will help validate and test RiskInsight®, KCC's catastrophe modeling platform. The QA Engineer will help validate KCC's proven-accurate catastrophe models and software processes...
-
Quality Assurance Engineer
1 month ago
Boston, United States Aloden, Inc. Full timeQuality Assurance Engineer Location - Boston Duration - 6-19 months Application Quality Assurance Engineer, CASM Platform (Cyber AI Application & Attack Surface Management) QA-Education & Qualifications •Education: Bachelor's degree in Computer Science, Information Systems, or a related field, or equivalent professional experience. •Experience: 5+ years...
-
Quality Assurance Engineer
1 week ago
Boston, Massachusetts, United States Vastek, Inc. Full timeAbout the RoleWe are looking for a Quality Assurance Engineer to support the Validation program at Vastek, Inc.Company OverviewVastek, Inc. specializes in Engineering, Validation, Regulatory, IT, and NON-IT areas primarily focused on Pharmaceutical/Life Sciences and Medical device companies.Key ResponsibilitiesThis position involves developing validation...
-
boston, United States Arcadis Full timeAbout The JobArcadis 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...
-
Senior Quality Assurance Engineer
5 days ago
Boston, United States Whitridge Associates Full timeOur client is seeking an experienced Sr. Data and Application Senior Quality Assurance (SQA) Engineer to join their team. This role is integral to ensuring the quality, reliability, and integrity of their Cyber AI application platform. The ideal candidate will have a passion for delivering robust testing solutions and collaborating across technical teams to...
-
Senior Quality Assurance Engineer
4 days ago
Boston, United States Whitridge Associates Full timeOur client is seeking an experienced Sr. Data and Application Senior Quality Assurance (SQA) Engineer to join their team. This role is integral to ensuring the quality, reliability, and integrity of their Cyber AI application platform. The ideal candidate will have a passion for delivering robust testing solutions and collaborating across technical teams to...
-
Quality Assurance Engineer
4 weeks ago
Boston, MA, United States Karen Clark & Company Full timeQuality Assurance Engineer Karen Clark & Company (KCC) seeks a Quality Assurance (QA) Engineer to join its software team in its beautiful Back Bay Boston office. The QA Engineer will help validate and test RiskInsight, KCC’s catastrophe modeling platform. The QA Engineer will help validate KCC’s proven-accurate catastrophe models and software...
-
boston, United States Whitridge Associates Full timeOur client is seeking an experienced Sr. Data and Application Senior Quality Assurance (SQA) Engineer to join their team. This role is integral to ensuring the quality, reliability, and integrity of their Cyber AI application platform. The ideal candidate will have a passion for delivering robust testing solutions and collaborating across technical teams to...
-
Quality Assurance Engineer Leader
6 days ago
Boston, Massachusetts, United States Search Masters, Inc Full timeSenior Quality Engineer Job DescriptionWe are seeking an experienced Quality Assurance Engineer Leader to join our team at Search Masters, Inc.About Search Masters, Inc.Since 1973, Search Masters, Inc. has been a leader in Northeast Ohio in Executive Search and professional placement. We specialize in the Engineering and Manufacturing Industries, with a...
-
Software Quality Assurance Specialist
7 days ago
Boston, Massachusetts, United States Owl Labs Full time**Job Overview**Owl Labs is seeking a detail-oriented and highly motivated Software Quality Assurance (SQA) Engineer to join our team. As an SQA Engineer, you will be responsible for ensuring the quality and reliability of our software products through rigorous testing and validation processes.
-
boston, United States Plymouth Rock Assurance Full timeSoftware Engineering ManagerPlymouth Rock Assurance is looking for a talented and motivated Software Engineering Manager who will lead a team of highly technical full stack Java Developers to design, develop, support and implement industry leading eBusiness applications for home owners and umbrella insurance. This person will lead inception/iteration...
-
Senior Validation Engineer
1 month ago
Boston, United States i-Pharm GxP Full timeJob Title: Validation Engineer – APSLocation: Boston, MAOverview:We are seeking 2-3 local Validation Engineers with 5-8 years of experience to support ongoing validation and APS (Aseptic Process Simulations) activities. Candidates should possess strong knowledge of validation principles, demonstrate autonomy in executing APS protocols, and have experience...
-
Process Engineer for Aseptic Filling
3 weeks ago
Boston, United States Validation & Engineering Group Inc. Full timeValidation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual...
-
Engineering Validation Specialist
3 weeks ago
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeJoin a World-Class R&D OrganizationTakeda is a forward-thinking, world-class R&D organization dedicated to delivering transformative therapies to patients worldwide. We are committed to pushing the boundaries of what is possible in order to bring life-changing treatments to those who need them.About the RoleWe are seeking a highly skilled Senior Specialist,...
-
Senior Director, Quality Assurance
2 weeks ago
Boston, United States Disability Solutions Full timeAbout the Job The Senior Director Quality Assurance (QA) will work as part of a new product team, focused on improving blood-based cancer diagnostic capabilities in areas such as cancer detection, minimum residual disease, and other related applications. This team is comprised of talent from across the Roche ecosystem, including Roche Diagnostics, Roche...
-
Engineering Validation Specialist
4 weeks ago
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeWe are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs at Takeda Pharmaceutical.Job OverviewThis role is responsible for ensuring compliance with GxP regulations and internal SOPs, as well as maintaining and improving documentation to maintain compliance to government...
-
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeAbout the JobWe are seeking a highly skilled Senior Specialist, Engineering and Validation to join our team at Takeda Pharmaceutical. As a key member of our engineering and validation team, you will be responsible for ensuring that equipment is installed, calibrated, and qualified in compliance with GxP regulations and internal SOPs.Key...
-
Process Optimization and Compliance Engineer
7 days ago
Boston, Massachusetts, United States Validation & Engineering Group Full timeValidation & Engineering Group, Inc. is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries. We are seeking a talented Aseptic Filling Systems Specialist to support our commercial pharmaceutical manufacturing operations.Key Responsibilities:Support the installation, validation,...
-
Senior Quality Assurance Engineer
1 week ago
Boston, Massachusetts, United States RQMIS Inc Full timeAbout the RoleWe are seeking a skilled Senior Quality Assurance Engineer to join our team at RQMIS Inc, a leading medical device and biotechnology consultancy. As a key member of our team, you will be responsible for providing expert guidance on quality system design and management, ensuring compliance with regulatory requirements.The ideal candidate will...
