CQV Engineer

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.

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.