Compliance Engineer for our DS Compliance & Support team in Manufacturing
FUJIFILM Diosynth Biotechnologies
Dato: for 3 uger siden
By: Hillerød, Region Hovedstaden
Kontrakttype: Fuld tid
Are you eager to learn and lead investigations? Ready to drive quality processes and pinpoint effective CAPAs? Do you thrive on engaging stakeholders and seeking challenges? If yes, this role is your next step!
Then look no further, as we have a unique opportunity to join us here at FUJIFILM Diosynth Biotechnologies as our Compliance Engineer. Come and join this fantastic team on our exciting journey!
Your New Role
As our Compliance Engineer, you'll manage and assess production incidents, applying suitable methodologies and leading cross-functional investigations into atypical occurrences. Your goal is to synthesize data, identify root causes, and implement strategies to prevent recurrence, ranging from simple events to high-risk deviations.
You'll be the key contact for presenting findings to customers, the organization, and auditors during inspections, requiring strong communication skills for engaging internal stakeholders, customer interfaces, and senior management. Your role is pivotal in enhancing organizational learning by applying thorough cause analysis techniques, including Human and Organizational Performance (HOP) principles, to each investigation.
The job includes rotating weekend work, limited to 2-4 weekends annually, with compensation provided.
Primary Responsibilities
The team is a Manufacturing Support function within the Drug Substance Manufacturing (DSM) Department. The main function of the team is to drive the quality deviation process to ensure we minimize recurrence of these incidents, learn, improve and ensure we continue to delight our customers and provide the patient with the highest quality product.
Who You’ll Be Working With
We are a dynamic, high performing team of 12 members representing 10 different nationalities. We excel by learning from each other, both culturally and technically, embracing mistakes as valuable learning opportunities. We prioritize humor and camaraderie, ensuring laughter and joy are integral to our daily work life.
Your application
Has this sparked your interest? Then we urge you to please upload your CV and cover letter as soon as possible as we screen applications on a continuous basis. We will take down the advert when the position has been filled.
If you have any questions related to the job, please reach out to Interim Supervisor, DS Compliance & Support, Manufacturing, Karoline Havkrog at phone: +45 2026 2057.
Working at FUJIFILM Diosynth Biotechnologies
We offer a competitive compensation package in a site/company growing rapidly, with many opportunities for individual growth, we also offer access to fitness and an attractive canteen.
FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina and College Station, Texas, USA. 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.
Our Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities, and technologies to manufacture advanced biologics. As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team.
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.
FUJIFILM Diosynth Biotechnologies Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identify or any other protected class.
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.
Then look no further, as we have a unique opportunity to join us here at FUJIFILM Diosynth Biotechnologies as our Compliance Engineer. Come and join this fantastic team on our exciting journey!
Your New Role
As our Compliance Engineer, you'll manage and assess production incidents, applying suitable methodologies and leading cross-functional investigations into atypical occurrences. Your goal is to synthesize data, identify root causes, and implement strategies to prevent recurrence, ranging from simple events to high-risk deviations.
You'll be the key contact for presenting findings to customers, the organization, and auditors during inspections, requiring strong communication skills for engaging internal stakeholders, customer interfaces, and senior management. Your role is pivotal in enhancing organizational learning by applying thorough cause analysis techniques, including Human and Organizational Performance (HOP) principles, to each investigation.
The job includes rotating weekend work, limited to 2-4 weekends annually, with compensation provided.
Primary Responsibilities
- Capture and assess the criticality of production incidents.
- Lead and facilitate cross-functional investigation teams.
- Drive quality deviation investigations actively.
- Conduct thorough investigations focused on performance improvement and risk reduction, complying with Pharmaceutical Quality System standards.
- Document findings in reports and ensure timely approvals.
- Share investigational findings internally and contribute to metrics related to investigation process and CAPA effectiveness.
- Present investigations to customers and during audits/inspections.
- Degree in Engineering, Pharmaceutical/Natural Science, or equivalent.
- 2-4 years of experience within a drug product manufacturing plant
- Expertise in Human and Organizational Performance (HOP) principles for improvement.
- Practical knowledge of cGMP, cGLP, EMEA and experience with customers, inspectors, and agency personnel.
- Strong technical writing skills and ability to synthesize information from multiple SMEs.
- Effective facilitation and management of diverse stakeholders.
- Ability to balance resource demands and analyze complex problems.
- Strong English communication skills for articulating issues across the organization and to customers.
- Experience with customer interface is a plus.
- Trust-building and collaborative across the organization.
- Proactive, curious, resilient, and neutral in investigations.
- Motivated by challenges and eager to make a significant impact.
- Outgoing with an action-oriented, can-do attitude suitable for an entrepreneurial environment.
The team is a Manufacturing Support function within the Drug Substance Manufacturing (DSM) Department. The main function of the team is to drive the quality deviation process to ensure we minimize recurrence of these incidents, learn, improve and ensure we continue to delight our customers and provide the patient with the highest quality product.
Who You’ll Be Working With
We are a dynamic, high performing team of 12 members representing 10 different nationalities. We excel by learning from each other, both culturally and technically, embracing mistakes as valuable learning opportunities. We prioritize humor and camaraderie, ensuring laughter and joy are integral to our daily work life.
Your application
Has this sparked your interest? Then we urge you to please upload your CV and cover letter as soon as possible as we screen applications on a continuous basis. We will take down the advert when the position has been filled.
If you have any questions related to the job, please reach out to Interim Supervisor, DS Compliance & Support, Manufacturing, Karoline Havkrog at phone: +45 2026 2057.
Working at FUJIFILM Diosynth Biotechnologies
We offer a competitive compensation package in a site/company growing rapidly, with many opportunities for individual growth, we also offer access to fitness and an attractive canteen.
FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina and College Station, Texas, USA. 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.
Our Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities, and technologies to manufacture advanced biologics. As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team.
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.
FUJIFILM Diosynth Biotechnologies Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identify or any other protected class.
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.
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