*Manufacturing Process Specialist

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Do you have experience in production of API and are now ready to step out of manufacturing and use your knowledge in a different way?

Are you passionate about process standardization and optimization? Do you get energized by shaping and implementing new improvements?

At AGC Biologics we are looking for an experienced manufacturing professional. We are seeking a highly skilled and motivated individual with several years’ experience in API manufacturing to join our team as a Manufacturing Professional/Specialist.

About the Role

You will be part of the Manufacturing Readiness and Compliance department, a newly established function within manufacturing. The department is responsible for enabling standardization and optimization of manufacturing processes via process knowledge, data insights and innovation.

In this role, you will be responsible for developing strategies for manufacturing processes and documentation, by driving standardization and harmonization efforts.

A big part of the role will entail ensuring compliance with regulatory authorities' requirements. The successful candidate will play a key role in optimizing workflows, procedures, and driving improvements related to manufacturing processes, especially in cross-functional collaboration.

As our new Manufacturing Professional/Specialist, you will:

  • Develop and implement process documentation strategies to optimize workflows and procedures.
  • Plan, drive, and execute standardization, global and local process harmonization, and digitalization of manufacturing processes and documentation
  • Ensure that manufacturing processes, templates, and documents consistently comply with regulatory authorities' requirements.
  • Author high-level procedures and related templates for manufacturing processes.
  • Ownership and responsibility for training materials related to manufacturing batch documentation
  • Provide support to manufacturing teams during audits and inspections.

Qualifications:

  • You have an educational background in bioengineering, natural sciences, pharmacy, or related field.
  • 3+ years’ experience working in manufacturing and deep understanding of manufacturing processes, batch records and workflows
  • Solid experience in GMP and regulative requirements of the health authorities regarding documentation
  • Experience defining and implementing standards for manufacturing documentation
  • Experience in project planning, coordination and implementation
  • Excellent English communication skills both written and spoken
  • Good communication, presentation, and interpersonal skills to engage with others
  • Master of basic Microsoft Office 365 applications (Word, PowerPoint, Forms) and it would be an advantage if you have experience with automation tools like PowerAutomate

On a personal level, you are a self-starter with a collaborative and service mindset who is comfortable working independently but also able to collaborate with others. You thrive in a multicultural and busy work environment. You listen, you evaluate, and you rarely accept the first “no” you get. As you have a structured approach to your work, you can juggle several tasks while prioritizing your efforts optimally by keeping the bigger picture in mind. You are a good team player who can prioritize and manage multiple tasks effectively.

Join an international and agile organization

At AGC, you will get great opportunities to work with a wide array of tasks and challenges, and you will get experience with our various departments. Furthermore, as we plan projects and tasks together in the team, you will get the opportunity to influence your daily work. AGC offers an informal working environment where high energy and enthusiasm is part of the daily work life. We respect each other and our individual differences. At AGC, we have a flexible attitude, and we help each other reach deadlines as a team.

Contact and application

For any further questions, you are more than welcome to contact Réka Almási at [email protected]. Please be aware that we take in consideration only the applications send via our career page and, not via email. We will process the applications as they arrive.

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 5.2.2024, 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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