Job Description
A fantastic opportunity has arisen for an Associate Specialist, Engineering.
Responsibilities
Generation, review and approval of process documentation.
Execution of development and qualification studies across commercial and non-commercial products.
Representing the Technical Operations department at cross‑functional meetings.
Development and qualification of new processes.
Qualification of new equipment where appropriate.
Lead and support investigations and troubleshooting of process studies as required.
Technical support for commercial manufacturing.
Technical support for new product introduction.
Ensure compliance with the QMS, industry/company specific standards and regulations.
Demonstrate effective communication and interpersonal skills.
Proactively act to consistently improve personal knowledge and capability.
Demonstrate an awareness of own capabilities and development needs.
Lead and support continuous improvement by active participation in and contribution to projects and problem‑solving, including use of production system processes and tools.
Application of technical knowledge to enable authoring of technical documents and technical decision‑making.
Support audit readiness, including preparation of story boards, ensuring GMP‑compliant documents are available, and presentation to auditors as required.
Work collaboratively to drive a safe and compliant culture on site.
Participate in driving a high‑performing and inclusive culture, stimulating personal growth and development.
May be required to perform other duties as assigned.
Accountable for contribution to ensure that objectives are effectively achieved, consistent with company and regulatory requirements.
Respond to operational and business areas, ensuring compliance with cGMP and company requirements.
Ensure that adequate processes and procedures are in place and followed for all relevant process activities.
Support business‑critical projects related to the Technical Operations department.
Provide technical support for cross‑functional programs and investigations.
Required Skills
Typical minimum education: Bachelor’s Degree; ideally in a science, engineering, or other technical discipline.
Proficiency in Microsoft Office and job‑related computer applications.
Excellent communication, presentation, and interpersonal skills.
Project management skills.
Flexible approach.
Effective time management and multi‑tasking skills.
Excellent attention to detail.
Troubleshooting skills.
Goal‑oriented and results‑focused.
Demonstrable analytical and systematic problem‑solving skills.
Applied engineering.
Communication.
Contractor oversight.
Driving continuous improvement.
Engineering standards.
Equipment qualification.
Estimation and planning.
GMP compliance.
GMP validation.
Internal audit controls.
Interpersonal communication.
Investigation procedures.
Lean manufacturing.
Manufacturing quality control.
Manufacturing scale‑up.
Manufacturing support.
New product introduction process.
Process control.
Process documentation.
Process optimisation.
Process scale‑up.
Regulatory requirements.
Teamwork.
Technology operations.
Writing technical documents.
Equal Opportunity Employer
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
Location
The Carlow site broke ground in 2008 and is a filling site for the launch and commercial supply of vaccines, biologics, and small molecule drug product. Since its initial launch, the site has attracted significant internal investment and is now home to a number of state‑of‑the‑art production facilities, laboratories, and temperature‑controlled warehousing units.
Employee Status
Regular
Flexible Work Arrangements
Hybrid
Job Posting End Date
06/17/2026
Requisition ID
R400828
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