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Job Description

As a Process Engineer, you will lead and support the development, optimization, and validation of manufacturing processes. This role involves supporting scaling up projects, improving efficiency and product quality, and collaborating with cross-functional teams to implement advanced manufacturing techniques. You will play a crucial role in problem-solving and troubleshooting production issues while driving continuous improvement initiatives to enhance manufacturing capabilities while ensuring compliance with regulatory standards.

Key Responsibilities

• Lead the design, development, and optimization of manufacturing processes for new and existing implantable medical device products.
• Collaborate with manufacturing teams and alliance partners on production development, technology transfer, and to define and implement efficient, scalable, and compliant production processes.
• Develop, document, and maintain process workflows, control plans, and standard operating procedures (SOPs).
• Conduct process validation activities, including IQ/OQ/PQ for new and modified manufacturing processes.
• Ensure validation protocols align with regulatory standards and are executed effectively to meet quality requirements.
• Identify, lead, and execute continuous improvement projects to enhance process efficiency, reduce waste, and improve product quality.
• Lead root cause analyses for any process failures or deviations, and implement corrective and preventive actions as necessary.
• Provide technical expertise and training to manufacturing staff on new processes, equipment, and quality standards.
• Ensure all production processes comply with medical device regulations and standards.
• Prepare, review, and maintain comprehensive documentation related to process design, validation, and improvement activities.

Skills and Requirements

• Minimum 3 years of experience in process engineering within the pharmaceutical industry.
• Strong understanding of GMP and other applicable regulatory requirements.
• Proficiency in process design, documentation, and validation methodologies.
• Experience with pharmaceutical cleanroom operations.
• Bachelor’s degree in engineering or a related field.
• Fluency in English, both verbal and written.

Personality

• Curious and Fast Learner.
• Adaptable and Self-Motivated.
• Collaborative Team Player.
• Strong Communicator.

Other Information

This is a remote or on-site role that involves regular business travel to our CMOs, located in Malmö. Additional travel to supplier sites or other company locations will occur based on business needs.

Job Overview

Are you passionate about technology and eager to work with some of the brightest minds in the Nordics in LabVIEW and TestStand? We are looking for a passionate and technically strong system developer with an interest in hardware and LabVIEW to develop innovative test and measurement systems for the industry.

Responsibilities

• Play a key role in ensuring the quality of software and hardware solutions.
• Work independently and collaboratively with system developers and software architects.
• Engage in the entire development process from idea and requirement analysis to design, coding, testing, and final solution.
• Develop specialized test systems for industries such as robotics and wind energy.
• Create data acquisition systems and specialized measuring instruments.
• Develop efficient and user-friendly production facilities.

Qualifications

• Relevant education in engineering, natural sciences, or computer science.
• 3-5 years of practical experience with LabVIEW and/or TestStand.
• Knowledge of version control and unit testing.
• Understanding of industrial communication technologies and protocols.
• Ability to convert physical signals into data through sensors and computer systems.
• Practical skills in building and troubleshooting physical test and measurement systems.
• Fluent in Danish and proficient in English.
• Experience with machine safety, CE marking, and risk assessments is a plus.

What We Offer

We offer a high ceiling both professionally and personally. We believe in the synergy of job satisfaction and learning, prioritizing both social and professional activities. Benefits include lunch and pension schemes, health insurance, fitness access, and opportunities for further education. We offer a salary based on qualifications.

Responsibilities

• Provide design, research, and drafts to develop functional products
• Design products based on customer requirements using internal calculation and design tools
• Technical processing and documentation of orders, ensuring that technical specifications comply with applicable directives and standards
• Support design engineering processes from inception through production for intermediate product development and existing products.
• Deliver final production drawings and documentation to the production team

Qualifications

• Understand dimensioning, materials (preferably stainless steel), and ideally have experience with pressure equipment
• Enjoy cross-functional collaboration and see the value in knowledge sharing and professional sparring
• Be curious and eager to learn, with an interest in working with international standards and specialized solutions
• Thrive in repetitive and precise design work where standards and details are key
• Have knowledge of the PED 2014/68/EU Directive and standards such as EN 13445, EN 13480, ASME, and EJMA (not a requirement)
• Ideally be familiar with SAP and technical calculation tools such as PV-elite

Job Description

Are you passionate about embedded software and Ethernet technologies? Join our organization's API team and help shape the future of Ethernet switch and PHY software interfaces. We’re looking for a skilled embedded developer to design and maintain OS-agnostic C APIs that enable advanced digital features in Ethernet devices used in automotive and industrial applications.

Key Responsibilities

• Design, develop, and maintain OS-agnostic C APIs for Ethernet PHYs and Switches.
• Focus on digital features such as:
• Auto-negotiation (aneg)
• Quality of Service (QoS)
• Time-stamping for IEEE 1588/PTP
• MACsec security
• Traffic shaping and policing.
• Ensure APIs are intuitive, extensible, and maintain backward compatibility.
• Contribute to and maintain automated test infrastructure for API validation.
• Write MISRA-compliant C code aligned with ASPICE and automotive safety standards.

Requirements/Qualifications

• Strong proficiency in C and embedded software development.
• Experience working in regulated environments with safety and quality standards.
• Ability to work independently and collaboratively in cross-functional teams.
• Solid communication skills in English (written and oral).
• Relevant technical education and 5+ years of applicable experience.

Additional Skills

• Experience with Ethernet switch SoCs and PHYs.
• Familiarity with IEEE 802.1Q and basic Layer 2 forwarding concepts.
• Knowledge of QoS and/or TSN standards.
• Experience with tools and standards such as GIT, MISRA, ASPICE, ISO 26262, and IEC 62443.
• Exposure to standardization bodies or industry consortia.
• Some experience with Linux (user-space or kernel-space), Ruby, and/or CMake.

What We Offer

• A key role in a team developing cutting-edge Ethernet technologies.
• Collaboration with experts in chip design, networking, and standards.
• International work environment with travel opportunities.
• Informal and pleasant office culture with meals and snacks provided.
• Competitive compensation and benefits including pension, healthcare, and stock options.

Travel Time

0% - 25%

To all recruitment agencies: Our organization does not accept unsolicited agency resumes. Please do not forward resumes to our recruiting team or other employees. We are not responsible for any fees related to unsolicited resumes.

Your New Role

You will have the technical ownership of the Automatic Inspection equipment operating in the Drug Product manufacturing suite. You will ensure to maintain validated state and operational performance of automatic inspection equipment as well as provide technical support to Operations, QC, and Quality for GMP and manufacturing events.

Main Tasks

• Develops and maintains equipment-related Recipes.
• Provides operational support for the automated inspection equipment including establishment of maintenance programs, spare part assessment and management, preparation of procedures, training, etc.
• Acts as second line support to maintenance organization in complex and unforeseen equipment issues—leading troubleshooting teams and activities and being the point of contact to suppliers. Responsible for driving and supporting GMP events related to equipment in scope such as Deviations, change controls, events, inspections.
• Provides support to tech transfer programs and Operations as Equipment owner.
• Participates in Operational board meetings and validation activities as well as acts as technical support to GMP events when validated state is impacted.

Your Skills & Talent

• +3 years’ experience as Senior Technician or + 2y as Engineer in Drug Product or Fill Finish manufacturing
• Knowledge of Validation and Risk Assessment of manufacturing equipment in GMP
• Vision engineering and / or Automatic inspection experience
• Have a technical background and appreciate dealing with technical challenges on the shopfloor

We hope you are

A positive team player with a can-do attitude eager to sharpen your technical skills and thrive a very dynamic environment with plenty of opportunity to take ownership

Your New Team & Department

DP MSAT covers a broad scope and play a central part in Drug Product Manufacturing. Our team is composed of process owners, responsible engineers, technology specialists, CQV leads and Pilot laboratory scientists.

We are in expansion phase as we get closer to clinical and commercial drug product manufacturing operations starting early 2026.

The work environment is international and informal. We keep a high pace and focus on a vital life balance while having fun. We put a strong emphasis on psychological safety through trust and empowerment within our teams and hope that this is something that speaks to you as well.

Application

Has this sparked your interest, then please upload your CV and cover letter in English as soon as possible, as we screen candidates on a continuous basis and call in for interviews.