Systems Engineer - eBR/MES, Process Engineering, Technical Operations

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The Process Engineering Department is looking for an experienced Systems Engineer for EBR/MES systems to assist AGC Biologics in our continuous growth. You will become part of an agile and newly established department of highly dedicated scientists and technicians that work closely with external customers and internal stakeholders.

Do you have a passion for Pharma 4.0 and new technology in biopharma manufacturing?

Do you want to be a key player in AGC’s digital transformation?

Do you want to join a growing company helping customers bringing new advanced biological products to market? Would you like to work at our multiproduct facility in Copenhagen?

Then join a dynamic and international company where teamwork makes us succeed and the sky is the limit!

About the job

As a System Engineer for eBR/MES you will be part of our Process Engineering group working together with skilled colleagues in a team with multiple focus areas.

You will be a fundamental contributor to develop, integrate and validate new IT/OT systems in the GMP manufacturing environments.

You will mainly be a part of the work package “Implementation of electronic Batch Recording and Manufacturing Execution Systems” and will take over administration of these systems once they are implemented.

Responsibilities

The essential duties during and after system implementation:

  • Draft and compile User Requirement Specifications (URS) and Design Reviews
  • Develop the design and system architecture of electronic Batch Recording (eBR)/ Manufacturing Execution Systems (MES) as part of a large-scale global project
  • Analyze business requirements for electronic Batch Recording (eBR)/ Manufacturing Execution Systems (MES)
  • Lead the implementation of EBR/MES concepts based on business requirements
  • Model the pharmaceutical manufacturing processes in eBR/MES
  • Manage updates and eBR rollouts for new products
  • Create and configure MES recipes, especially for customizing the connection of MES to production lines/equipment
  • Implement eBR/MES training for end users, as well as support for system testing in the validated environment
  • Be the contact point for system users
  • Be the primary vendor contact
  • Maintain and implement continuous improvement in Manufacturing IT systems
  • Manage the lifecycle of the eBR/MES computerized system and plan for obsolescence of related hardware and software

Qualifications

  • Bachelor’s degree in Science or Engineering, IT, Computer Science, or related discipline
  • Minimum five years of experience working with computerized systems in Manufacturing, with at least some experience in eBR/MES such as PAS-X, FactoryTalk, Syncade, PLEX, or others
  • High IT affinity and interest in process modeling in software applications
  • Familiarity with regulatory (FDA/EMA) requirements

Further things you will need to be successful

  • Preference given for control systems, process control techniques, automation technology, common programming languages or configuring a workflow automation platform
  • Basic understanding of manufacturing processes within the pharmaceutical industry and ability to read construction and process drawings
  • Strong knowledge of Computer System Validation, including ISPE GAMP 5
  • Strong knowledge in regulatory guidance as well as understanding of how they are applied to regulatory compliance, e.g. FDA guidelines, cGMP, 820, OSHA, 21 CFR Part 11, and other related CFRs.
  • Proven ability to work independently and in a team environment
  • Experience in project management and delivery
  • Flexible and adaptable to changing priorities with strong multi-tasking and organizational skills
  • Excellent problem solving and communications skills i.e. verbal, written and presentation (fluent in English)
  • Proficient in MS Project and the MS Office Suite of products

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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 3.2.2022, men kan have været deaktiveret og genaktiveret igen.

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

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