Senior CQV engineer with experience in Automation & IT

JOB - LINK A/S; Gentofte Kommune; On-site; DKK 900,000 - 1,200,000; Full time

Benefits offered by this job

Career opportunities

International work environment

Job summary

A leading engineering firm in Denmark seeks a Senior CQV Engineer specializing in Automation & IT for pharma projects. You will manage project execution, develop documentation, and ensure compliance with regulatory standards. Ideal candidates should hold a Bachelor's in Electronics or Communication Engineering and possess over 12 years of automation experience across various industries. Strong analytical skills and experience with PLC, SCADA, and DCS are crucial. Join a results-oriented team in an international organization with growth opportunities.

Qualifications

• 12+ years of diversified automation experience across various industries.
• Experience integrating PAS-X with process analytical instruments.
• Skilled in industrial network configuration and troubleshooting.
• PAS‑X integration experience for automated data capture and compliant workflow execution.
• Strong GMP, GAMP 5, and data-integrity knowledge with IT risk assessments.

Responsibilities

• Develop and manage comprehensive CQV documentation.
• Lead CQV activities for SCADA and PLC systems.
• Execute end-to-end testing of DCS-integrated CIP skids.
• Ensure licensing compliance for SCADA platforms and OPC UA server–client environments.
• Integrate vendor equipment into DCS/PLC platforms and validate end-to-end system interfaces.

Skills

Experience with PLC, SCADA, and DCS systems

Knowledge of pharmaceutical manufacturing processes

Strong analytical and problem-solving skills

ISA-88/ISA-95 knowledge

GMP compliance

Validation planning

IT risk assessments

FAT/SAT

DCS-PLC-SCADA interfaces

OPC UA

VMP familiarity

Education

Bachelor’s degree in Electronics and Communication Engineering

Tools

PCS platforms

Industrial routers

SCADA

PLC/Control Studio

OPC UA servers

Job description

Job-Link A/S

Senior CQV engineer with experience in Automation & IT

Please note To be considered for this position, candidates must hold a valid work and residence permit for Denmark.

Job-Link are seeking a highly skilled Automation & IT Specialist /Sr. Engineer to manage and execute various technical aspects of our customers projects in the pharma industry. The ideal candidate will be responsible for the development and implementation of comprehensive project execution and validation plans, as well as ensuring compliance with IT risk assessments. You will work closely with cross-functional teams to deliver high-quality documentation, functional specifications, and technical reports.

Key Responsibilities

• Develop and manage comprehensive CQV documentation—including Installation Verification (IV), Operation Verification (OV), and Commissioning protocols—and support full FAT and SAT execution to ensure equipment and system compliance with GMP requirements and regulatory standards.
• Good working knowledge of upstream bioprocess operations, including seed bioreactors, production bioreactors, and single-use mixers, CIP, SIP, with a strong understanding of associated automation and control system requirements.
• Testing and verifying CIP skids are integrated with the DCS to ensure proper communication, sequence execution, and compliant cleaning operations.
• Performing end-to-end testing of DCS-integrated CIP skids to ensure reliable cleaning cycles and seamless equipment interfacing.
• Performing functional testing of SIP recipes to confirm compliant sterilization, proper sequencing, and accurate DCS execution.
• Verifying CIP and SIP hygiene status to ensure equipment meets required cleanliness and sterilization standards before production use.
• Integrated four vendor-supplied WFI systems with the DCS to enable automated monitoring, control, and compliant operation of this critical utility.
• Lead the development, documentation, and approval of interface agreements for integrations across Delta V DCS–PLC, DCS–SCADA, DCS–PAS‑X, SAP–PAS‑X, and PLC–SCADA systems, ensuring compliant data flow.
• Provide CQV leadership for the design, development, programming, and commissioning of SCADA and PLC systems, while driving PAS‑X installation, configuration, qualification, and release in accordance with Validation Master Plans (VMPs).
• Ensure licensing compliance for SCADA platforms and OPC UA server–client environments, maintaining complete adherence to vendor requirements.
• Working knowledge of installing and configuring OPC UA servers, batch servers, and historian databases to enable secure connectivity and compliant data management.
• Knowledgeable in designing SFC sequences for DCS‑based automation and proficient in developing expression logic in Control Studio to support precise and structured control functionality.
• Carry out comprehensive IT risk assessments for biopharmaceutical manufacturing systems—covering data integrity, cybersecurity, backup/restore, and system lifecycle controls—to ensure alignment with GAMP 5 and global GMP expectation.
• Demonstrate deep expertise in ISA‑88 batch control architecture and a strong understanding of ISA‑95 integration models across all four automation levels, enabling robust alignment between MES and process control systems.
• Develop detailed interface protocols and create test plans to execute and validate production recipes within automated and GMP‑compliant manufacturing environments.
• Execute PID tuning on critical bioprocess control loops, including PCBIO, TCU temperature loops, and bioreactor vent/inlet pressure loops, ensuring stable, precise, and compliant control.
• Apply advanced proficiency in all six PID controller modes—CAS, AUTO, RCAS, ROUT, MAN, and OOS—to optimize loop performance, troubleshoot system deviations, and ensure consistent process outcomes.
• Conduct comprehensive I/O testing and configure control valves across multiple communication protocols (HART, Foundation Fieldbus, Profibus, ASI, Ethernet), ensuring accurate instrumentation behavior and system integration.
• Configure, troubleshoot, and align ATF process parameters across Siemens PLC and Delta v DCS platforms, supporting high‑cell‑density cultivation, stable upstream bioprocess performance.
• Knowledge of integrating PAS‑X, Line Optimizer, OPC UA communication layers, and Delta V DCS to support synchronized, automated recipe execution and robust equipment interfacing.
• Integration of vendor Provided Equipment—including TCUs, Jet Mixers, Shaker Incubators, and ATF units—into DCS and PLC platforms using Landing Module Class architecture.
• Integrated GE Fanuc pick‑and‑place robots with PAS‑X and PLC systems using PAS‑X workflow interfaces.

Who you are (Preferred Competencies)

We care about who you are as a person. In the end, how you work, and your energy is what impacts the effort we make as a team.

• Experience working with automation platforms including PLC, SCADA, and DCS systems, with hands‑on involvement in configuration, troubleshooting, and system commissioning.
• Good understanding of pharmaceutical manufacturing processes and production‑optimization principles to support efficient, reliable, and compliant automation workflows.
• Knowledge of automated inventory‑management logic and exception handling, strengthened by PAS‑X integration to ensure accurate material tracking and GMP‑compliant workflow execution.
• Proficient in creating comprehensive technical documentation and user guides to support automation system operation, troubleshooting, maintenance, and qualification readiness.

In all positions there are some things that are needed, and others a bonus. We believe these qualifications are needed for you to do well in this role:

• Bachelor’s degree in Electronics and Communication Engineering.
• 12+ years of diversified automation experience across power plants, biopharmaceutical manufacturing, water‑treatment facilities, and oil & gas industries.
• Experienced in validating and testing industrial communication protocols across major PLC platforms—including Rockwell, Siemens, Mitsubishi— and integrating with gateway systems such as RTA, Modbus TCP/RTU, enabling reliable multi‑vendor and multi‑system connectivity.
• Experience integrating PAS‑X with process analytical instruments such as osmometers and rapid analyzers to enable automated data capture, result verification, and compliant workflow execution.
• Skilled in industrial network configuration and troubleshooting, including setup of Phoenix Contact industrial routers, managed switches, VLAN configurations, network segmentation, firewall rule management, and the design of secure automation network topologies.
• Strong working knowledge of regulatory frameworks, including GMP, GAMP 5, 21 CFR Part 11, and data‑integrity expectations, ensuring automation deliverables meet stringent pharma/biotech compliance requirements.
• Excellent analytical and problem‑solving skills, applying structured troubleshooting methodologies to optimize control strategies, improve equipment performance, reduce failures, and enhance system stability.
• Extensive experience working on large‑scale industrial automation projects, including pharmaceutical filling lines using Rockwell systems and major water‑treatment plant automation projects, contributing throughout design, integration, FAT/SAT, commissioning, and validation phases.
• Comprehensive experience integrating and communicating with motion‑control systems, including Servo drives, VFDs, and other motor‑control platforms across multiple industries, ensuring precise motion control, speed regulation, and interface with PLC/DCS systems.
• Managed over 7,000 I/O points across a large scale MABS facility, overseeing signal integration, control strategy alignment, and seamless automation system performance.

We offer

a job in a result‑oriented working environment in an international organization with many contacts and career opportunities.

Application details

We will call qualified candidates for interview as soon as we get it - and go further with the process - if you match the job. Are you interested, then please send you applications as soon as possible.

Relevant candidates will be asked to provide consent for a criminal record check at a later stage in the recruitment process.

Please note that due to GDPR-rules we only received CV and applications on the link below.

If you have any questions regarding this jobposting, please contact Kristine Kjærulff Pedersen

[e-mail]
Tlf.: [phone]

Application deadline: As soon as possible