Position:
Drug Product (DP) Engineer – Formulation- Contract
Location:
Dundalk, Ireland
Role Overview
We are seeking a
Drug Product Engineer – Formulation
to provide technical leadership within a vaccine drug product manufacturing environment. The role focuses on ensuring safe, compliant, and efficient operation of equipment, supporting continuous improvement initiatives, and maintaining cGMP standards throughout the facility.
Key Responsibilities
* Provide technical guidance in the operation and maintenance of equipment within the Drug Product manufacturing suite.
* Ensure equipment and processes comply with cGMP regulations, industry standards, and internal engineering policies.
* Review, author, and execute testing protocols, SOPs, risk assessments, and manufacturing documentation.
* Manage equipment vendors, including maintenance visits, spare parts assessment, and continuous improvement projects.
* Support and lead equipment revalidation and maintenance of validated states according to site procedures.
* Collaborate in cross-functional teams to troubleshoot technical issues, optimize processes, and implement improvements using tools such as
DMAIC
and
FMEA
.
* Manage change control for equipment and processes, ensuring all modifications are documented and compliant.
* Lead or participate in equipment-related investigations, ensuring thorough root cause analysis and CAPA implementation.
* Identify process and equipment improvements and convert them into continuous improvement projects.
* Provide technical support for batch disposition and production ramp-up, addressing any mid-batch issues.
* Participate in TPM, CI, Gemba programs, and tiered manufacturing meetings.
* Provide technical expertise during regulatory inspections, supporting documentation and defending engineering practices.
Requirements
* Minimum 5 years of experience in
cGMP industrial or engineering environments
.
* Hands-on experience with
FAT, SAT, IQ/OQ
execution.
* Strong analytical skills with experience in
root cause analysis
and data-driven continuous improvement initiatives (e.g., Six Sigma).
* Experience leading and resolving complex technical investigations.
* Risk-based manufacturing experience using tools such as
FMEA
.
* Ability to adapt to changing priorities in a fast-paced environment.
Education
* Bachelor's degree in
Engineering, Science, or a technology-related discipline
.
Preferred Skills & Experience
* Practical experience with
autoclaves, parts washers, CIP/SIP systems
.
* Knowledge of
formulation processes
and drug product manufacturing.
* Experience in
start-up facilities
and
CQV
activities.
* Familiarity with regulatory standards, e.g., Annex 1.
* Strong technical writing, communication, planning, and organizational skills.