CQV Engineer

1 day ago

Boston MA United States DPS Group Global Full time

Summary
Arcadis DPS Group Global is seeking a highly skilled CQV Engineer with specialized expertise in qualifying filling line isolators for biotech and pharmaceutical applications. The ideal candidate will play a key role in ensuring the reliability, efficiency, and compliance of the manufacturing processes by leading the qualification efforts for isolator systems used in filling operations.

Key Responsibilities

  • Lead the qualification and validation activities for filling line isolators, including IQ, OQ, and PQ phases, in accordance with regulatory requirements and company standards.
  • Develop and execute validation protocols, test scripts, and procedures to demonstrate the functionality and performance of isolator systems.
  • Collaborate closely with cross-functional teams, including engineering, manufacturing, quality assurance, and regulatory affairs, to ensure alignment and compliance with project requirements.
  • Perform risk assessments and impact analyses to identify and address potential issues related to isolator qualification and validation.
  • Troubleshoot and resolve technical issues and deviations encountered during qualification activities, ensuring timely resolution and minimal impact on project timelines.
  • Generate comprehensive validation documentation, including reports, summaries, and final qualification packages, for review and approval.
  • Provide technical support and guidance to internal stakeholders on isolator qualification and validation best practices, procedures, and regulatory requirements.
  • Stay informed about industry trends, regulatory updates, and best practices related to isolator qualification and validation, and incorporate relevant knowledge into project activities.
  • Maintaining (and ensuring the team maintains) clear, detailed records of qualification and validation, and change control activities for future compliance audits.

Skills & Qualifications

  • B.S. / M.S. in engineering or another relevant discipline.
  • 5-8 years of experience as a validation engineer in the medical/pharmaceutical industry.
  • Minimum of 4 years of experience in commissioning, qualifying, and validating isolator systems for biotech and pharmaceutical manufacturing.
  • Experience in the areas of Design Documentation (URS, FRS, DS, and other engineering specifications), Validation (IQ, OQ, PQ, PV, CSV, MVP, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc).
  • Understanding of c.G.x.P principles and familiarization with ISO 13485, ISO 14971, and 21C.F.R.820.
  • Working knowledge of Computer Systems Validation lifecycle and documentation.
  • Proficient in Microsoft Word, Excel, PowerPoint.
  • Must be able to work independently with adequate supervision, multi-task, and support several projects simultaneously.
  • Must demonstrate strong communication, interpersonal and teamwork skills.
  • A strong understanding of technical writing and presentation skills is required.

The Company
Arcadis DPS Group is a global EPCM firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. DPS is dedicated to delivering successful projects with a ‘client-first’ mentality and personal touch across a range of market sectors: Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up.

Arcadis DPS Group is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. DPS does not discriminate in employment opportunities or practices on the basis of: race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.

#J-18808-Ljbffr

  • CQV Consultant

    1 day ago

    Boston, MA, United States Azzur Group Full time

    Azzur Group is a leading consulting firm specializing in life sciences, providing innovative solutions in Commissioning, Qualification, and Validation (CQV) to our esteemed clients. We are committed to delivering exceptional service and expertise, ensuring compliance with regulatory standards and optimizing operational performance. Join our dynamic team and...

  • CQV Engineering Consultant

    2 days ago

    Boston, MA, United States Precision Medicine Group, LLC. Full time

    CQV Engineering Consultant - Project Management Location: Boston Massachusetts United States Job Type: regular full-timeDivision: Precision for MedicineBusiness Unit: Manufacturing SolutionsRequisition Number: 4147 Welcome to the forefront of innovation in cutting edge patient centered treatments! We are seeking the best and the brightest to join our high...

  • CQV Engineer

    1 month ago

    Boston, MA, United States Trinity Consultants - Advent Engineering Full time

    CQV Engineer (Biotech)Location – MAADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Head-quartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and...

  • CQV Engineering Consultant

    1 day ago

    Boston, MA, United States Precision Medicine Group Full time

    Welcome to the forefront of innovation in cutting-edge patient-centered treatments! We are seeking the best and the brightest to join our high-performing organization as a CQV Engineering Consultant . As a leader within the life science industry, we are constantly pushing the boundaries of what is possible and redefining the standards of excellence. Our...

  • CQV Engineer

    2 months ago

    Boston, United States Trinity Consultants - Advent Engineering Full time

    CQV Engineer (Biotech)Location – MAADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Head-quartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and...

  • CQV Engineer

    2 months ago

    boston, United States Trinity Consultants - Advent Engineering Full time

    CQV Engineer (Biotech)Location – MAADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Head-quartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and...

  • CQV Engineer

    2 months ago

    Boston, United States Trinity Consultants - Advent Engineering Full time

    CQV Engineer (Biotech)Location – MAADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Head-quartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and...

  • CQV Engineer

    4 weeks ago

    boston, United States Trinity Consultants - Advent Engineering Full time

    CQV Engineer (Biotech)Location – MAADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Head-quartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and...

  • Commissioning & Qualification (CQV) Engineering Consultant

    4 weeks ago

    Framingham, MA, United States Sequence Inc. Full time

    We are currently interviewing candidates to join Sequence, Inc. as CQV Consultants within our Southeast Operations with most projects focused in the pharmaceutical/biotechnology industries. In this role, you will be responsible for a range of projects related to the commissioning & qualification of automated manufacturing systems including laboratory...

  • Commissioning & Qualification (CQV) Engineering Consultant

    1 month ago

    Framingham, MA, United States Sequence Inc. Full time

    We are currently interviewing candidates to join Sequence, Inc. as CQV Consultants within our Southeast Operations with most projects focused in the pharmaceutical/biotechnology industries. In this role, you will be responsible for a range of projects related to the commissioning & qualification of automated manufacturing systems including laboratory...

  • CQV Engineer

    1 month ago

    Wilson, NC, United States US Tech Solutions Full time

    Duration: 12 months contract, Full-TimeEmployment Type: W-2Job Description:· Leading and coordinating the commissioning field team including CQ engineers, automation engineers, operator and site engineers, JSI sampling technicians, and external vendors and contractors.· Candidate should be local to Wilson, NC or nearby. For the first 6 months of the role,...

  • Senior Validation Engineer

    2 weeks ago

    Boston, United States i-Pharm GxP Full time

    Job 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...

  • Senior Validation Engineer

    2 weeks ago

    Boston, United States i-Pharm GxP Full time

    Job 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...

  • DeltaV Support Engineer

    1 month ago

    Raleigh, NC, United States Technical Source Full time

    Technical Source is currently in search of an DeltaV Support Engineer for our pharmaceutical client located in Raleigh-Durham, NC area. The qualified candidate will have experience providing technical oversight and CQV documentation support to the integration of DeltaV process control systems in a GMP environment.Responsibilities of the DeltaV Support...

  • i-Pharm GxP | Senior Validation Engineer | boston, ma

    2 weeks ago

    boston, United States i-Pharm GxP Full time

    Job 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...

  • i-Pharm GxP | Senior Validation Engineer | boston, ma

    2 weeks ago

    boston, United States i-Pharm GxP Full time

    Job 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...

  • Computer Systems Validation Engineer

    2 days ago

    Boston, MA, United States PCMC Full time

    About Us: BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals from Strategy to Commercialization. As the only firm born from a manufacturing technology company to become an independent and fully integrated firm, we combine...

  • Senior Facilities Engineer

    4 weeks ago

    Burlington, MA, United States Vericel Corporation Full time

    Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Engineering professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to...

  • Process Engineer

    1 month ago

    Wichita, KS, United States Hughes Consulting, A Salas O'Brien Company Full time

    Hughes Consulting, A Salas O'Brien Company is an exciting, fast-growing company focused on Process Engineering, Project Engineering, Project Management and CQV solutions for the pharmaceutical industry. We offer great benefits, and exciting challenges for both career and personal leadership development. Company Culture Guidelines & Values:We are...

  • Senior Specialist, Engineering and Validation

    2 weeks ago

    Boston, MA, United States Takeda Pharmaceutical Full time

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...