• Job Description

  Req#: JR1712

  We are looking for a CQV Engineer and/or QA professional to join the expansion project. The person will initially be supporting CQV activities such as Design deliverables from EPCM and Vendors including Drawings, Datasheets, specifications, Engineering Lists and shop CQV activities. When the project is implemented you will transition to the daily QA operations team.

  About the Team and the project

  The Project team consists of skilled specialists supporting the Validation of our new expansion projects in Hillerød. Together, you be part of shaping the QA mindset for the future and we like to have fun while doing so. Supporting each other in the daily routine tasks as well as projects to be executed is done through very open and honest communication within the team and in very close collaboration with our colleagues in the QA and Validation. We are a deeply committed multicultural team who takes great pride in working with all types of stakeholders on all levels of the organization.

  Job Responsibilities

  Your primary tasks while working on the project are:

  • Support generation of all CQV Documentation – FAT wraparounds, DQ, RTM, QRA, SAT/IOC and IOQ, including Final Reports.
  • Support CQV review and approval of all Turnover Packages, both Vendor and Contractor
  • Participate in field Mechanical Completion walkdowns for all systems.
  • Support execution of all systems testing and CQV deliverables; FAT/SAT/IOC/IOQ
  • Liaise with CQV SWAT Team, Contractors and Vendors in relation to punchlist closure both pre-M/C and during the CQV execution phase
  • Support PSSR/STW field execution start-up exercise in a safe and controlled manner.
  • Liaise with all Project Groups (Design/CM/CQV/Automation/Process/SMEs/Ops/Maintenance/PMs) to ensure all Systems are managed appropriately for the entire Project Lifecycle.
  • Participate in CQV meetings and ensure updates are provided to appropriate forum

  Your primary tasks while working in QA will be:

  • QA Review of equipment, automation and cleaning related validation and test documentation
  • Perform approval of campaign change over from one product to another
  • Exceptions handling, review and approval of change controls, alarms and work orders
  • Act as primary QA contact for Automation, Validation, Engineering, DSM Manufacturing Support team, Manufacturing Management, Process Science team, Quality Control and Manufacturing Associates
  • Participate in execution of audits and inspections and act as subject matter expert
  • Involvement in challenging cases and projects together with key stakeholders
  • Furthermore, the possibility of performing QA review of process related batch documentation

  Qualifications

  • You hold a Master of Science within Pharmacy, Biotechnology, Biology or similar
  • You have 1-3 years of CQV experience including experience with design and construction projects for biopharmaceutical manufacturing facilities.
  • Some work experience within the pharmaceutical industry, preferably within Quality Assurance
  • You have solid GMP/Good Documentation Practices knowledge and QA and/or manufacturing experience from the pharmaceutical industry that allows for understanding of the complexity of manufacturing biologics
  • Experience with complex projects and working in or around operating facilities.
  • Ability to keep work pace and meet deadlines. Good organizing and planning skills.
  • Demonstrated proficiency communicating and collaborating at a variety of levels with customers, vendors, equipment suppliers and operations staff.
  • Proven success working well in a team environment with flexibility to react to changing business needs.
  • Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Project)
  • Fluent in English both verbally and in writing

  Personal qualifications

  • Ability to keep work pace and meet deadlines. Good organizing and planning skills.
  • Demonstrated proficiency communicating and collaborating at a variety of levels with customers, vendors, equipment suppliers and operations staff.
  • Proven success working well in a team environment with flexibility to react to changing business needs.
  • Strong communication skills. Problem solver with a focus on achievement of overall project goals
  • You are a team player who is motivated by working in a dynamic environment with a strong focus on providing support to both colleagues and stakeholders.
  • You focus on details and deadlines but can keep an overview that enables you to take a holistic and pragmatic approach.
  • You take ownership of your work and feel comfortable by independently resolving issues.
  • You have solid interpersonal skills and enjoy cooperating with colleagues from different cultures, on all levels and from different functions with the focus of building a strong collaboration and trust in your network.

  Your Application

  Please upload your CV and cover letter in English as soon as possible as we screen candidates on a continuous basis.

  About FUJIFILM Diosynth Biotechnologies

  FUJIFILM Diosynth Biotechnologies, a subsidiary of FUJIFILM Corporation, is a world-leading contract development and manufacturing organization (CDMO) with experience in the development and manufacture of biologics, vaccines and advanced therapies The company operates a global network with major locations in the Unites States of America, the United Kingdom and Denmark and it is building a new manufacturing site in Holly Springs, North Carolina, USA.

  FUJIFILM Diosynth Biotechnologies has over thirty years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway™ microbial and Apollo™X cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing.

  We use our skills, dedication and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.

  We offer the chance to be part of a global workplace where passion, drive and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone no matter their background or gender has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.

  We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package.

  To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

• About the company

  A global CDMO in pharmaceutical manufacturing providing process development and cGMP production in cell culture, microbial fermentation and gene therapies.

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