Senior Specialist, Bioprocess & Technical Engineering

MSD Malaysia; Swords; On-site; EUR 110,000 - 140,000; Full time

Job summary

We are seeking a Senior Bioprocess & Technical Engineering Specialist to join our manufacturing network in Ireland. You will lead the introduction, scaling and improvement of complex biological processes, working with internal sites and external partners to ensure readiness for new technologies and robust, compliant operations.

You will report to the Director of Bioprocess & Technical Engineering and drive engineering excellence across the network, delivering data-driven decisions and lifecycle

Qualifications

• Bachelor's degree in engineering, biology or related field and 7+ years in engineering, manufacturing or tech transfer.
• 7+ years in biologics drug substance manufacturing with facility design, process engineering or commercial manufacturing support.
• Strong understanding of GMP environments, quality systems and change control.
• Excellent communication and ability to influence across cross-functional teams.
• Experience with global regulatory requirements and inspections.

Responsibilities

• Lead facility-fit and manufacturing readiness assessments for new products.
• Develop mass balances and capacity models for manufacturing feasibility and capacity planning.
• Drive technology identification and platform alignment to support scalable biologics manufacturing.
• Establish and promote platform technology standards and best practices.
• Support digital engineering tools and data-driven decision making for facility readiness and lifecycle management.
• Provide technical leadership and mentorship to internal teams and external partners.
• Lead cross-functional assessments for product introductions, tech transfers, and process changes.
• Drive continuous improvement through standards, digital capabilities and knowledge management.

Skills

Leadership

Communication skills

Problem solving

Cross-functional collaboration

GMP experience

Change control

Education

Bachelor's degree in engineering or life sciences

Job description

Lead Role

Job Description We’re looking for a Senior Specialist in Bioprocess & Technical Engineering to join our team and make a significant impact on our manufacturing network. This is a key leadership role where you will have the opportunity to shape how complex biological processes are introduced, scaled and improved.

You will work with our internal sites and external partners to enhance our technical capabilities, ensure our facilities are ready for new technologies and lead initiatives that directly support the quality and supply of life-changing products for patients. Our team thrives on technical excellence, collaboration and a shared commitment to making a difference. We work closely with teams across Manufacturing, Science & Technology, Quality and Engineering to solve challenges and ensure our processes are robust and efficient. In this role, you will report to the Director of Bioprocess & Technical Engineering and play a vital part in setting high standards across our network.

Responsibilities

• Lead facility-fit and manufacturing readiness assessments by evaluating new products against existing site capabilities, identifying facility, equipment sizing, utility and operational constraints, and defining strategies to enable successful technology transfer and commercialisation.
• Develop and own process mass balances and capacity models to assess manufacturing feasibility, technology requirements, equipment utilisation, buffer and media demands, and end-to-end process performance across the product lifecycle.
• Drive technology identification and platform alignment by evaluating process technologies, manufacturing strategies, and equipment solutions that support robust, scalable and standardised biologics manufacturing across the network.
• Establish and champion platform technology standards by defining, implementing, and governing manufacturing platforms, process design principles, and engineering best practices to maximise consistency, transferability and operational excellence.
• Support the development and deployment digital engineering tools and models that enable data-driven decision making for facility fit assessments, mass balance development, capacity planning, equipment selection, technology transfer readiness, and lifecycle management.
• Provide technical leadership and mentorship to internal teams and external partners, ensuring engineering solutions are scientifically sound, operationally sustainable, compliant, and aligned with platform strategies.
• Support/lead cross-functional technical assessments and investigations supporting new product introductions, technology transfers, process changes, and manufacturing optimisation initiatives, utilizing structured problem-solving methodologies to identify root causes and implement effective solutions.
• Drive continuous improvement and innovation through the development of engineering standards, digital capabilities, knowledge management systems, and scalable approaches that improve transfer success rates, reduce complexity, and enhance manufacturing robustness.
• Shape the future manufacturing network by contributing to technology roadmaps, facility expansion strategies, capital investment decisions, and technical due diligence activities for new products, emerging technologies, and strategic partnerships.
• Foster a culture of engineering excellence by promoting technical rigor, knowledge sharing, accountability, innovation, and continuous learning across the organisation.

Qualifications and Requirements

• A Bachelor’s degree in engineering, biological sciences or a related field, with at least seven years of relevant experience in engineering, manufacturing or technology transfer.
• A minimum of 7 years of experience in biologics drug substance manufacturing, with a background in facility design, process engineering or commercial manufacturing support.
• A strong technical understanding of biologics manufacturing processes, equipment and automation.
• The ability to lead and influence in a collaborative, cross-functional environment.
• Excellent communication skills, with the ability to explain complex technical ideas to a variety of audiences.
• A talent for connecting technical details to broader business goals, such as supply reliability and quality.
• An inclusive leadership style that helps create a psychologically safe and accountable work environment.
• Experience with Good Manufacturing Practices (GMP) environments, quality systems and change control.
• Strong problem-solving, organisational and prioritisation skills.

Preferred Experience

• Experience in monoclonal antibody drug substance manufacturing.
• Expertise in upstream or downstream biologics process engineering.
• Familiarity with new product introductions, Process Performance Qualification (PPQ) and lifecycle management.
• Knowledge of continuous improvement methods like Lean Manufacturing or Six Sigma.
• Experience with global regulatory requirements and supporting health authority inspections.
• A willingness to travel up to 20% may be required.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.