Current jobs related to CQV Engineer - Boston - DPS Group Global
-
CQV Engineer
1 month ago
Boston, Massachusetts, United States DPS Group LLC Full timeJob Title: CQV EngineerWe are seeking a highly skilled CQV Engineer to join our team at DPS Group LLC. As a CQV Engineer, you will play a key role in ensuring the reliability, efficiency, and compliance of our manufacturing processes by leading the qualification efforts for isolator systems used in filling operations.Key Responsibilities:Lead the...
-
CQV Engineer
1 month ago
Boston, Massachusetts, United States DPS Group LLC Full timeJob Title: CQV EngineerWe are seeking a highly skilled CQV Engineer to join our team at DPS Group LLC. As a CQV Engineer, you will play a key role in ensuring the reliability, efficiency, and compliance of our manufacturing processes by leading the qualification efforts for isolator systems used in filling operations.Key Responsibilities:Lead the...
-
CQV Engineer
4 weeks ago
Boston, United States Trinity Consultants - Advent Engineering Full timeCQV 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
1 week ago
boston, United States Trinity Consultants - Advent Engineering Full timeCQV 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
1 month ago
Boston, United States Trinity Consultants - Advent Engineering Full timeCQV 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 timeCQV 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
1 month ago
Boston, United States LVI Associates Full timeResponsibilitiesThe role entails the primary job functions:Execute IC/OC commissioning protocols for fermenters and the CIP skidTroubleshoot and resolve all commissioning issuesGenerate the commissioning summary reports for all respective protocols.Generation of the qualification protocols for the fermenters & CIP skids.Execute IQ/OQ qualification...
-
Performance Monitoring Specialist
1 week ago
Boston, Massachusetts, United States DPS Engineering Full timeJob SummaryDPS Engineering is seeking an experienced Performance Monitoring Specialist to join our team in Boston, MA. This role requires a strong background in validation activities, with a focus on equipment commissioning and qualification.Key ResponsibilitiesDevelop and maintain equipment commissioning and validation protocolsSupport site validation...
-
Facilities Engineering Senior Specialist
2 weeks ago
Boston, Massachusetts, United States Vertex Pharmaceuticals Full timeJob SummaryThe Facilities Engineering Senior Specialist is a key member of the Global Engineering and Capital Project Management team at Vertex Pharmaceuticals. This role provides science-centric facility, equipment, and utility engineering expertise to all global sites, with a primary focus on GMP manufacturing sites and a secondary focus on R&D lab and...
-
Facilities Engineering Senior Specialist
2 weeks ago
Boston, Massachusetts, United States Vertex Pharmaceuticals Full timeJob Title: Facilities Engineering Senior SpecialistThe Facilities Engineering Senior Specialist is a key member of the Global Engineering and Capital Project Management team at Vertex Pharmaceuticals. This role provides science-centric facility, equipment, and utility engineering expertise to all global sites, with a primary focus on GMP manufacturing sites...
-
Continuous Improvement Manager
1 week ago
Boston, Massachusetts, United States Reily Foods Company Full timeJob SummaryReily Foods Company is seeking a highly skilled Continuous Improvement Manager - Beverage Operations to drive technical excellence and process improvement across our beverage manufacturing operations. This role will be responsible for ensuring the technical capability exists to deliver an improved consumer experience at an optimized price, while...
-
Senior Manager, Validation and Compliance
1 week ago
Boston, Massachusetts, United States Vertex Pharmaceuticals Full timeJob Summary:The Senior Manager, Validation and Compliance position will be part of the Vertex Cell and Genetic Therapy Manufacturing Operations and Technical Operations group. This role will oversee Validation personnel and support managing day-to-day Validation operations at VCGT facilities for the T1D program at the greater Boston location. The incumbent...
CQV Engineer
2 months ago
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
