*Lead Process Engineer

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Do you have a keen interest in capacity analysis, facility fit assessments, and process optimization? Are you motivated by the opportunity to collaborate with end-users and witness the tangible impact of your contributions? Are you dedicated to upholding high compliance standards and eager to work with cGMP regulations in the context processing equipment for biopharmaceutical bulk API manufacturing? Then this role may be a perfect fit for you.

About the department:

You can look forward to becoming part of a dynamic and well-functioning team consisting of Process Engineers, Equipment Responsible Engineers, and Support Technicians. We thrive on professional challenges and work independently with great individual responsibility and a high level of commitment. We collaborate with diverse stakeholders in the organization at site and global levels including Production departments, IT, MSAT, and QA as well as with colleagues from our sister sites in the US, Japan, and Germany. We enjoy contributing to a wide range of activities and projects within the organization. You will experience an enthusiastic working climate focused on quality, teamwork, and delivery.

Your primary responsibilities will be:


  • Development implementation cost models for project development and implementation.
  • Leading cross-functional collaborations to meet project timelines requirements.
  • Perform facility fit assessments and capacity analysis during new product introduction (NPI) stages and for CAPEX expansion projects
  • Managing manufacturing process improvements/changes requiring cross-functional oversight
  • Supporting implementation of new processes in manufacturing operations.
  • Ownership of equipment modules and packages through design, procurement, installation, commissioning and qualifications phases
  • Collaborating with key departments and personnel in technology transfer projects
  • Leading or assisting implementation of new manufacturing equipment to enable transition from early clinical trials to late stage and commercial GMP processes

Desired Competencies:


  • A scientific education (BSc or MSc) in Engineering, Bioprocessing, Biology or related discipline is required.
  • 5+ years of working experience with cGMP, with knowledge of documentation systems (i.e., BPRs, Validation Protocols, Standard Operating Procedures (SOPs), expense budget, work orders, purchasing systems) of a business in the biopharmaceutical industry;
  • Experience with the full-scale production of Active Pharmaceutical Ingrediencies (API) with a holistic understanding of manufacturing processes and facilities for cGMP manufacturing of biological intermediates and APIs for mammalian and microbial bulk production processes,
  • Engaging with stakeholders of various backgrounds comes naturally to you and you demonstrate your leadership and project management skills, as they are required to work with multi-disciplinary teams.
  • Demonstrate a high level of initiative in troubleshooting and accurate data analysis.
  • The ability to balance many tasks simultaneously
  • Experience with LEAN manufacturing
  • Basic knowledge of PI systems Experience, MES and EBR

In addition, you must thrive in a dynamic and fast-paced working environment where changes occur on short notice. The environment is dynamic and challenging at times, which requires finding solutions, delivering on promises, and giving our customers a positive experience. AGC has international customers, equipment suppliers and our company language is English. It is therefore a required ability that communication in both written and spoken English is fluent.

At AGC Biologics, you will get a unique opportunity working with a variety of different state of the art technologies among +40 different nationalities. This opens many doors for personal and professional development and for you to make a real difference towards patients, our customers, and your personal and professional growth. AGC offers an informal working environment, characterized by the fact that we think it is fun to go to work. We respect each other and our differences. AGC employees are flexible and take pride in working together to achieve goals as one team.

Applications are screened on an ongoing basis. You do not need to attach a cover letter to your application, but please include a few sentences about your motivation for applying to this position.

Want to keep posted about our growth and to learn more about our company?

We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook !

AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.


Information og data

Denne ledige stilling har jobtypen "Projektleder", og befinder sig i kategorien "Ledelse og personale".

Arbejdsstedet er beliggende i København

Jobbet er oprettet på vores service den 14.11.2023, men kan have været deaktiveret og genaktiveret igen.

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Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Projektleder
  • København
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