CrawlJobs Logo

Cqv lead

darwinrecruitment.com Logo

Darwin Recruitment GmbH

Location Icon

Location:
United States

Category Icon

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided

Job Description:

CQV Lead for a Greenfield Pharmaceutical Biologics Facility. 12-month contract initially but will be a 3-year program.

Requirements:

  • 10+ Years Experience: Proven track record in CQV, CSV, and GxP environments
  • Full Lifecycle Mastery: Overseeing the journey from URS/FDS through IQ/OQ/PQ to final Summary Reports
  • Operational Readiness: Ensuring the facility is technically and regulatorily prepared for commercial manufacturing
  • Project Controls: Proactively identifying scope creep and communicating schedule/cost impacts
  • Performance Metrics: Utilizing Earned Value Management (EVM) to track team productivity and milestone completion
  • Schedule Ownership: Managing the technical critical path to ensure on-time delivery
  • Communication & Logistics: Serving as the technical point of contact for life science clients
  • Mobility: Ready for domestic and international travel to support site-specific execution
  • Compliance: Fluent in English with high-caliber technical writing skills

Nice to have:

Experience having worked on a Greenfield site previously is highly beneficial

Additional Information:

Job Posted:
January 22, 2026

Job Link Share:

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Cqv lead

Lead Engineer CQV

Discover your exciting role. Exyte is a global leader in design, engineering and...
Location
Location
Germany , Nürnberg
Salary
Salary:
Not provided
exyte.net Logo
Exyte Central Europe GmbH
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Degree in Biotechnology, Pharmaceutical, Building Services Engineering or Process Engineering or related field
  • Several years of experience in CQV within life sciences industry, including leadership responsibilities
  • Strong knowledge of GMP, ISO, 21 CFR, Annex 15, data integrity
  • Proven ability to lead teams and manage complex projects
  • Fluent German and good English skills required
  • High level of quality awareness, efficiency, and accuracy
Job Responsibility
Job Responsibility
  • Lead and mentor CQV engineers, ensuring efficient resource allocation and professional development
  • Define CQV strategies and ensure alignment with project objectives, timelines, and compliance requirements
  • Supervise commissioning, qualification, and validation activities for HVAC, cleanroom, and clean media systems according to GMP regulations
  • Approve CQV documentation (specifications, risk analyses, protocols, reports) and ensure regulatory compliance
  • Act as primary interface between CQV team, clients, technical engineering, automation, QA, and suppliers
  • Oversee FAT/SAT activities and review supplier documentation
  • Implement best practices and drive process optimization across projects
What we offer
What we offer
  • Your Start at Exyte: Join a two-day onboarding event with new colleagues
  • Attractive Location: Spacious workspaces with height-adjustable desks
  • Buddy System: Several weeks of onboarding with your teammates
  • Work-Life Balance: Option to switch to mobile working at any time
  • Catering: Free specialty coffees and water dispensers on every floor
  • Stay Fit: Exyte subsidizes your fitness membership via Qualitrain at over 5,000 locations across Germany
  • Fulltime
Read More
Arrow Right

Thermal Validation & CQV Engineer

We are seeking an experienced Thermal Validation & CQV Engineer to lead and exec...
Location
Location
Canada , Toronto
Salary
Salary:
Not provided
amaris.com Logo
Amaris Consulting
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in Engineering, Pharmaceutical Sciences, Microbiology, or a related discipline
  • 3–6 years of CQV/CSV/thermal validation experience in a GMP pharmaceutical or biotech environment (Consultant/Intermediate level)
  • Strong hands-on experience with thermal cycle development, heat penetration studies, and BI logistics
  • Strong hands-on experience with temperature mapping and smoke studies
  • Strong hands-on experience with IOQ/PQ execution and requalification activities
  • Solid understanding of FAT/SAT, risk-based validation, FCCA, RTM, and CSV principles
  • Proficiency in Kaye AVS systems and familiar with Kneat and/or Veeva Vault
  • Strong knowledge of GMP/GLP/GDP/EHS and ALCOA+ data integrity standards
  • Excellent skills in technical writing, data/statistical analysis, and problem-solving
Job Responsibility
Job Responsibility
  • Lead and execute CQV activities for facilities, utilities, and process equipment across routine operations and capital projects
  • Author and review risk-based C&Q documentation: FCCA, RTM, DQ, CTP, IOQ/PQ, EM PQ, smoke studies, and thermal validation protocols
  • Plan and perform FAT/SAT, critical test plans, and CSV activities where applicable
  • Perform thermal validation using Kaye AVS v1.4+ (or equivalent)
  • Validate sterilization and decontamination systems
  • Support annual validation programs
  • Investigate and document deviations and non-conformances
  • Own documentation and scheduling
  • Collaborate closely with Operations, MSAT, Automation, Engineering & Maintenance, and Quality teams
  • Promote continuous improvement and provide mentorship and guidance to junior validation staff
What we offer
What we offer
  • An international community bringing together more than 110 different nationalities
  • An environment where trust is central: 70% of our leaders started their careers at the entry level
  • A strong training system with our internal Academy and more than 250 modules available
  • A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.)
Read More
Arrow Right

CQV Coordinator Pharmaceuticals

We are looking for a CQV manager to provide documented evidence that all equipme...
Location
Location
Belgium , Beerse
Salary
Salary:
Not provided
amaris.com Logo
Amaris Consulting
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 5+ years in pharmaceutical GMP environment
  • Technical Expertise: Aseptic/sterile equipment and processes
  • Education: Technical-scientific degree preferred
  • Languages: Fluency in English is mandatory and Dutch is a strong advantage
  • Systems: KNEAT experience preferred
Job Responsibility
Job Responsibility
  • Coordinate qualification activities for assigned projects/changes/modifications
  • Own technical content of Equipment Qualification files (URS, SRS, SIA, CARA, DQ, QP, IQ, OQ, PQ, QSO)
  • Act as Technical Owner within the organization
  • Review and approve qualification documents in KNEAT (paperless system)
  • Lead core team/planning meetings for assigned projects
  • Maintain Kanban cards for work overview
  • Manage test planning, materials, and resources with cross-functional teams
  • Ensure timely, qualitative execution of qualification activities
  • Ensure GMP compliance throughout qualification lifecycle
  • Identify gaps in procedures/files and propose improvements
What we offer
What we offer
  • Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees
  • Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions
  • International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe
  • Fulltime
Read More
Arrow Right

Senior CQV Specialist

Biocomposites is an international medical devices company that engineers, manufa...
Location
Location
United Kingdom , Keele
Salary
Salary:
Not provided
jobs.360resourcing.co.uk Logo
360 Resourcing Solutions
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Level 6 within a science regulated industry or relevant experience
  • Minimum 8 years validation experience within pharmaceutical/medical devices, including cleaning, analytical methods, lab equipment, and computer system validation and re-qualification
  • Creation of validation documentation from URS to VSR, SVMP (subject to QA input)
  • Knowledge of Quality Management Systems
  • Comprehensive knowledge and experience with the following industry regulations and guidance: FDA 21 CFR Part 820 (Quality System Regulation for Medical Devices), ISO 13485:2016 (Medical Devices - Quality Management Systems), ALCOA+ principles for data integrity (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available), ICH Q9 (Quality Risk Management) and its application to validation/qualification
  • Excellent communication skills
  • Ability to meet deadlines
  • Attention to detail
  • Demonstrate a positive and enthusiastic attitude
Job Responsibility
Job Responsibility
  • Organise and lead validation activities to provide an effective validation service
  • Ensure all required documentation for a validation exercise, including validation protocols and summary reports, are created and maintained
  • Provide input and technical expertise for the creation and revision of relevant Standard Operating Procedures (SOPs) and other quality/validation documentation
  • Plan validation activities to ensure customer and business needs are met in alignment with the overall project plans, objectives and schedules
  • Ensure design projects relating to processes, facilities, equipment, and computer system validation are in compliance with regulatory and company requirements
  • Provide validation support and advice to operations and other areas of the business as required to ensure that all operations are carried out in compliance with regulatory and company requirements
  • Provide specialist knowledge on validation of
  • process, facility, equipment and application of computer systems used within production and service
  • Support a continuous improvement culture within the business
  • Ensure staff have required knowledge and training when performing validation activities on department, site, processes, and procedures
What we offer
What we offer
  • Company events
  • Company pension
  • Employee discount
  • Free or subsidised travel
  • Free on-site parking
  • Fulltime
Read More
Arrow Right
New

Software Engineer II (Mobile)

The Microsoft 365 India team is looking for a high calibre and highly motivated ...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
https://www.microsoft.com/ Logo
Microsoft Corporation
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's Degree in Computer Science or related technical field AND 4+ years technical engineering experience with coding in languages including, but not limited to, C, C++, C#, Java, JavaScript, or Python
  • OR equivalent experience
  • Ability to design efficient algorithms and data structures and write tight and neat code
  • Independently can handle design and implementation of features of right complexity
  • Any exposure to Office technology, iOS / Android / Azure Services is desirable
  • 4+ years of software development experience with C, C++ or Objective-C/Swift/SwiftUI
  • Ability to quickly pick up existing concepts and employ new techniques and strong problem solving
Job Responsibility
Job Responsibility
  • Implement features in a way it confirms to overall architecture of the area
  • Write automation, create test plan and come up with estimates based on the tasks
  • Quickly learn new areas and to adhere to quality and coding/design practices of the team
  • Be self-driven, proactive, results-oriented and have the commitment to continue to improve with feedback
  • Have exposure to agile methodology and all phases of the development cycle, preferably on large-scale commercial products is desirable
  • Fulltime
Read More
Arrow Right
New

Administrative Assistant

Robert Half is the world’s first and largest specialized talent solutions firm t...
Location
Location
United States , Norfolk
Salary
Salary:
Not provided
https://www.roberthalf.com Logo
Robert Half
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Provides administrative support to all upper management and including Project Managers
  • Maintain physical and digital filing systems
  • Manages the main switchboard and directs callers to appropriate personnel, schedules appointments, signs for incoming packages and assists clients and visitors
  • Responds to emails and other digital queries and correspondence
  • Receives incoming mail, sorts, and delivers to the intended receipts
  • Manage calendars for employees time off as well as the attendance calendar
  • Drafts and edits quotes, reports, and other documents as needed
  • Inputs and updates information in databases and spreadsheets
  • Prepares safety meeting agenda and takes meeting minutes
  • Maintains Safety Programs, digitally and hard copies
What we offer
What we offer
  • medical
  • vision
  • dental
  • life and disability insurance
  • 401(k) plan
Read More
Arrow Right
New

Host

Join one of the UK's leading hospitality businesses as a host. In our busy airpo...
Location
Location
United Kingdom , Manchester
Salary
Salary:
12.32 - 12.88 GBP / Hour
jobs.360resourcing.co.uk Logo
360 Resourcing Solutions
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Great people skills
  • Excellent organisational and multitasking abilities
  • Ability to maintain a positive attitude in a fast-paced airport environment
  • Flexibility in hours, airport shifts can start at 3am
  • Be able to provide a 5 year work/education/personal reference history and undertake a criminal record check
Job Responsibility
Job Responsibility
  • Create unforgettable guest experiences
  • Make sure guests holiday's start off right, delivering warm welcomes with a positive attitude to manage the queue at peak times
  • Collaborate with team members to ensure smooth service
  • Maintaining high energy and standards throughout your shift
What we offer
What we offer
  • Free meals on shift
  • Up to 30% discount at all our brands with no limit on number of guests
  • Duty free discounts excluding alcohol and cigarettes
  • Access to a great discount platform, saving you money on everyday purchases
  • Wagestream platform to access your wages as they are earned
  • Superb training and development, apprenticeships open to all
Read More
Arrow Right
New

Ai Motion Specialist

We’re looking for a creative AI motion specialist (all genders) with a strong ba...
Location
Location
Germany , Berlin
Salary
Salary:
Not provided
zalando.se Logo
Zalando Sverige
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum 3 years of professional experience in motion graphics, animation, or a comparable creative role, supported by a portfolio that includes AI-driven video or motion work
  • Strong technical proficiency with AI video and motion tools, such as Gemini / Veo or similar generative AI platforms
  • Proven ability to collaborate effectively within cross-functional teams and communicate clearly with colleagues and stakeholders in fluent English
  • Proactive and innovative mindset, with a demonstrated interest in exploring new AI video capabilities and driving creative improvement
  • Excellent time management, adaptability, and resilience in fast-paced environments with evolving tools, shifting requirements, and rapid iteration cycles
Job Responsibility
Job Responsibility
  • Work hands-on with AI video and image generation, including text-to-video and image-to-video pipelines, while contributing to concept-driven creative development
  • Use tools such as Adobe After Effects, Premiere, Photoshop, and other relevant software to produce high-quality motion content
  • Apply a strong aesthetic sensibility, particularly within fashion-focused visuals
  • Stay up to date with industry trends and emerging technologies, integrating innovative techniques into motion projects
  • Manage multiple projects in parallel and deliver high-quality results under tight deadlines
  • Creating AI based motion elements, animations, and visual effects for our digital banners and campaign assets
  • Close collaboration with multiple teams to deliver visually compelling content that is aligned with Zalando’s brand visual language and identities
What we offer
What we offer
  • Employee shares program
  • 40% off fashion and beauty products sold and shipped by Zalando, 30% off Lounge by Zalando, discounts from external partners
  • 2 paid volunteering days a year
  • Hybrid working model with up to 60% remote per week
  • Work from abroad for up to 30 working days a year
  • 27 days of vacation a year to start for full-time employees
  • Relocation assistance available (subject to prior agreement)
  • Family services, including counseling and support
  • Health and wellbeing options (including Wellhub, formerly Gympass)
  • Mental health support and coaching available
  • Fulltime
Read More
Arrow Right