Automation Engineer

Mantell Associates; Denmark; Sur place; DKK 900 000 - 1 300 000; Plein temps

Résumé du poste

Mantell Associates, in partnership with an international engineering and consulting firm, is seeking an experienced Automation Engineer for a large-scale greenfield pharmaceutical expansion in Denmark. The project features six parallel production lines across design, FAT/SAT, installation, and CQV.

You will work in ABB 800xA environments across AC 800M, Batch Management, and I/O validation, ensuring GMP, GAMP5, and 21 CFR Part 11 compliance while coordinating with process engineering, vendors,

Qualifications

• Bachelor's or Master's degree in Automation, Control Systems, Electrical, Chemical, or related engineering.
• Proven hands-on ABB 800xA DCS experience including AC 800M and Batch.
• Experience across design, FAT, installation, commissioning and CQV.
• GMP, GAMP 5 and 21 CFR Part 11 knowledge.
• Experience in pharmaceutical GMP environments.

Responsabilités

• Design control philosophy and FDS/URS for lines in design.
• Configure and program ABB 800xA control applications.
• Plan and execute FAT and SAT protocols across multiple lines.
• Lead on-site commissioning and start-up troubleshooting.
• Coordinate with process engineering, CQV, ABB, and construction teams to align automation deliverables with the project schedule.
• Ensure compliance with GMP, GAMP 5, and 21 CFR Part 11.

Connaissances

ABB 800xA DCS

AC 800M

Batch Management

GAMP 5

P&ID

FDS/URS

FAT/SAT

CQV

GMP

21 CFR Part 11

SIS

IEC 61511

MES integration

PAS-X Werum

English proficiency

Formation

Bachelor's or Master's in Automation/Control/Electrical/Chemical or related engineering

Outils

ABB 800xA

AC 800M

Description du poste

Mantell Associates is partnered with an international engineering and consulting company, who are searching for an experienced Automation Engineer to join a large-scale greenfield pharmaceutical manufacturing expansion in Denmark.

The project spans six new production lines running in parallel, each at a different stage of the lifecycle, from early control system design through FAT/SAT to site installation, commissioning, and qualification. Working within the ABB 800xA Distributed Control System (DCS) environment, you will flex between design, execution, and commissioning activities depending on the needs of each line. This is a multi-year build-out, so strong prioritisation and the ability to context-switch between the following will be key:

• Control philosophy and functional design specification (FDS/URS) development for lines still in design


• Control system configuration, application software build, and testing (FAT) for lines in execution


• Site installation support, loop checking, and commissioning (SAT/CQV) for lines nearing start-up


• Support and troubleshooting for lines transitioning into operational qualification and handover


• Develop and review automation design documentation, including functional design specifications, control narratives, P&ID markups, and I/O lists for ABB 800xA-based control systems


• Configure and program ABB 800xA control applications, including AC 800M controllers, batch management, and operator graphics, in line with GAMP 5 and client automation standards


• Plan and execute Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) protocols across multiple production lines


• Lead or support on-site commissioning activities, including loop checks, I/O verification, interlock testing, and start-up troubleshooting


• Coordinate with process engineering, qualification (CQV), automation vendors (ABB), and construction teams to align automation deliverables with the project schedule for each line


• Ensure all automation work complies with GMP, GAMP 5, 21 CFR Part 11, and internal quality and validation requirements


• Manage and track deviations, punch lists, and change requests relating to control system scope through to closure


• Support integration between the ABB 800xA DCS and MES/historian and other plant IT/OT systems as required


• Contribute to risk assessments relevant to automation scope, including HAZOP follow-up actions and SIL/interlock reviews


• Provide clear status reporting to the Automation Project Lead across all six lines, flagging risks to schedule or quality early


• Bachelor's or Master's degree in Automation, Control Systems, Electrical, Chemical, or a related engineering discipline


• Proven hands-on experience with ABB 800xA DCS, including AC 800M configuration, Control Builder, and Batch Management (System 800xA Batch)


• Experience across the full automation project lifecycle: design, FAT, installation, commissioning, and qualification (CQV)


• Prior experience within a pharmaceutical, biotech, or other GMP-regulated manufacturing environment is highly desirable


• Familiarity with GAMP 5 computer system validation principles and documentation practices


• Working knowledge of P&IDs, cause and effect matrices, and control narratives


• Experience on greenfield or large capital expansion projects, ideally with multiple concurrent workstreams


• Strong stakeholder coordination skills, comfortable working with vendors (particularly ABB), construction contractors, and internal process and quality teams


• Proficiency in English is essential; Danish language skills are an advantage but not required


• Experience with safety instrumented systems (SIS) and functional safety standards (e.g. IEC 61511) preferred


• Knowledge of MES integration (e.g. PAS-X, Werum) or plant historian systems preferred


• Experience with electrical/instrumentation loop drawings and I/O checkout tools preferred