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Dps Group Global

Manufacturing Deviations Specialist

Company logo
Dps Group Global
Global consultancy delivering engineering, construction management & advisory for high‑tech manufacturing facilities.
Manufacturing Deviations Specialist investigates root causes, manages CAPAs, ensures GMP compliance.
9d ago
Intermediate (4-7 years), Junior (1-3 years)
Full Time
Boston, MA
Onsite
Company Size
2,850 Employees
Service Specialisms
Engineering
Consulting
Project Management
Design
Architecture
Construction services
Technical Services
Turnkey
Sector Specialisms
Life Sciences
Pharmaceutical
Biotechnology
Medical Technology
Advanced Technology
Semiconductor
Data Centres
Alternative Energy
Role
What you would be doing
process monitoring
batch documentation
sop development
capa management
quality oversight
deviation investigation
  • Monitor process operations to ensure compliance with specifications.
  • Develop batch records, SOPs and training materials as needed.
  • Closely partner with peers for rapid review of batch-related documentation.
  • Participates in determining objectives of assignment and plans, schedules and arranges own activities in accomplishing milestone achievements.
  • Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.
  • Author and review SOPs, policies and batch production/testing records to ensure compliance and adherence to regulations/cGMP operations.
  • Identify and assemble proper SMEs for triage, determine immediate actions taken, document impact assessments, lead RCA, develop appropriate CAPAs
  • Utilize knowledge to improve operational efficiency.
  • Must be able to work under general direction to plan, coordinate, and ensure completion of engineering team deliverables.
  • Assist in the investigation of procedural deviations.
  • Participate in quality oversight of manufacturing through real-time observations of activities.
  • Lead, write and review deviations and investigations for VCGT, including the manufacturing, facilities, supply chain/materials management and support QC deviations as necessary.
  • Reviews minor manufacturing deviations.
  • Oversees execution of CAPAs, deviations and change controls in support of PCV manufacturing.
What you bring
gmp
bachelor’s
qms
cell manufacturing
deviations
leadership

Deviations Specialist (Pharmaceutical)

  • At least 3-4 years of QA or Manufacturing experience in a GMP manufacturing environment with a Bachelor’s Degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical Engineering, Biochemistry or related field.
  • Demonstrate a general knowledge of standard manufacturing compliance, quality disposition, and quality system review.
  • Excellent interpersonal, teamwork, and leadership skills required.
  • Ability to collaborate fluidly with peers, supervisors and cross-functional support groups required
  • Demonstrated understanding of the principles and applications associated with cell and gene manufacturing operations, maintenance/calibration, engineering, and validation
  • Proficiency in writing deviations
  • Exceptional written, oral communication, and organizational skills required
  • Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP or GLP
  • Experience working in an electronic Quality Management System
  • Effective verbal and written communication skills.
Benefits
Information not given or found
Training + Development
Information not given or found
Company
Overview
1974
Founded
Established in 1974, laying the foundation for their global advisory services in engineering, consulting, and construction management.
€289M
Revenue
Generated €289 million in revenue in 2021, driven by industry-led demand and the Chips Acts.
  • Built a reputation designing complex life-science and semiconductor plants for industry giants.
  • In 2022, they merged into Arcadis, combining strengths to offer end-to-end services across the built environment.
  • Their projects span high-tech manufacturing: biotech labs, pharma plants, EV battery gigafactories, data-centers, and advanced R&D hubs.
  • Their engineering teams guide clients from concept through qualification, commissioning, and validation.
  • They thrive in tightly regulated sectors, solving intricate process-design and facility-integration challenges.
  • Unusually, they combine deep sector expertise with full construction oversight—no handoffs, single trusted advisor.
Culture + Values
  • We put people at the heart of everything we do.
  • Our people make us who we are, and we believe in creating an inclusive culture where everyone can thrive.
  • We embrace innovation to deliver exceptional solutions.
  • We are passionate about delivering quality, ensuring we exceed expectations.
  • We act with integrity and honesty, promoting ethical decision-making.
Environment + Sustainability
2050
Net Zero Goal
Committed to achieving net zero emissions, aligning with global sustainability efforts.
50%
Carbon Emissions Reduction Target
Aiming for a significant reduction in operational carbon emissions, demonstrating commitment to climate action.
100%
Climate Resilience Projects
Ensuring all projects contribute to climate change adaptation and resilience, emphasizing comprehensive sustainability.
  • Provide innovative solutions for waste reduction, water conservation, and resource optimization, advancing the circular economy.
  • Incorporate sustainability into projects, influencing environmental performance through design, planning, and engineering.
Inclusion & Diversity
30% Target
Women in Leadership Roles
Aiming to increase the proportion of women in leadership positions within the organization by 2025.
50% Representation
Gender Balance Across Organization
Aim to achieve equal gender representation across all levels of the organization by 2030.
  • Implemented a global inclusion strategy to promote diversity and gender equality.
  • Estimated increases in gender equality.
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