Engineering Specialist

CPI Biotech; Cork; On-site; EUR 42,000 - 54,000; Full time

Benefits offered by this job

Career advancement

Supportive work environment

Flexible working arrangements

Free on-site parking & EV charging

Job summary

CPi Biotech in Cork seeks an Engineering Specialist to support the design, development and validation of single-use technologies, championing quality, regulatory compliance and continuous improvement.

Bachelor’s degree in engineering or life sciences, 1–2 years in biopharma, GMP awareness, strong Excel skills, and teamwork. Flexible working and ongoing career growth are offered.

Qualifications

• Minimum 1–2 years’ experience in the biopharmaceutical industry.
• GMP knowledge desirable.
• Strong analytical skills and attention to detail with Excel data tracking and reporting.
• Proactive, solutions-oriented problem solving.

Responsibilities

• Assist in design and development of new single-use assemblies.
• Support specification development of single-use components (tubing, bags, pumps, etc.).
• Design and execute validation studies from scope to shop-floor execution.
• Assist qualification of new components to meet GMP requirements.
• Prepare and manage engineering qualification documentation and activities.
• Provide engineering support for introducing new components to drawings and BOMs.
• Coordinate with clients and internal teams to deliver projects on time.
• Track progress and address material-related challenges.
• Support quality and client investigations during progression of projects.
• Work within a project team reporting to Engineering Lead.

Skills

Excel proficiency

Analytical thinking

Team collaboration

Communication skills

Problem solving

Education

Bachelor’s degree in engineering/Life sciences

Tools

Excel

Job description

About the Company

Based in Little Island, Cork, CPi Biotech is a specialist engineering company designing and manufacturing innovative single-use technologies and advanced bioprocessing systems for the global biopharmaceutical industry. Working with leading pharmaceutical and biotechnology companies globally, we deliver high-quality, GMP-compliant solutions that support the manufacturing and delivery of life-saving medicines and vaccines. Specifically, the company specializes in the production of GMP-compliant single-use assemblies, 2D and 3D bags & other such technologies that are extensively deployed throughout the biopharmaceutical industry. The company focuses on single use component selection, assembly design, assembly qualification, assembly manufacturing, supported with extensive validation studies necessary to deliver efficient, flexible, and cost-effective single use solutions.

About the Role

As the company continues to grow, we are seeking to recruit Engineering Specialists to support the design, development, and validation of our single-use technologies, championing product quality, regulatory compliance, and continuous improvement in the company and in the industry in which we operate.

Responsibilities

• Assist in the design and development of new single use assemblies
• Support in the selection and specification development of single use components, including tubing/biopharmaceutical bag film/pressure, temperature, UV, pH etc/pumps and other such equipment
• Design and executive extensive validation studies from high level scoping of the study, to writing detailed protocols and through to cleanroom/shop floor execution
• Assist in the qualification of new components ensuring they meet relevant quality and GMP requirements
• Support in the preparation and management of engineering related qualification documentation and associated activities
• Provide engineering support in the introduction of new single use components to general arrangement drawings and Bills of Materials (BOMs)
• Liaise with clients and internal teams in the successful delivery of new projects within agreed timelines
• Assist with coordinating project activities, tracking progress, and addressing material-related challenges
• Provide engineering related support in the progression of quality and client investigations
• Work collaboratively as part of a project team, reporting to the Engineering Lead

Qualifications

Bachelor’s degree in engineering, biochemistry, life sciences, or a related discipline.

Required Skills

• Minimum 1 to 2 years’ experience working in the biopharmaceutical industry
• Basic knowledge of biopharmaceutical manufacturing processes as well as Good Manufacturing Practice (GMP) is desirable
• Strong analytical skills and attention to detail, with proficiency in Microsoft Excel for data tracking and reporting
• A proactive, solutions-oriented approach to problem-solving
• Strong written and verbal communication skills, including the ability to present technical information
• Ability to work effectively within a team, manage priorities, and contribute to projects in a collaborative environment

Preferred Skills

• Experience with single-use technologies (SUT) is highly preferred
• Familiarity with single use GMP-compliant design, qualification, supply chain management, or materials engineering is an advantage

Pay range and compensation package

Competitive salary and benefits package including Company Health Scheme and access to Pension Plan.

Additional Benefits

• Opportunities for career advancement in a rapidly expanding company
• A dynamic, supportive work environment with a focus on professional growth
• Flexible working arrangements
• Free on-site parking & access to EV Charging
• Active Sports & Social Club