Senior Equipment Engineer

The Senior Equipment Engineer will lead the technical scope of a capital project for a new end-to-end (E2E) syringe manufacturing line, including processing, inspection, labeling, and secondary packaging.

This role will act as the technical lead for the equipment, translating user and business requirements into engineering solutions. Will work closely with equipment vendors, internal stakeholders, and the project manager to ensure successful design, build, testing, and integration of the manufacturing line.

This position requires a combination of strong engineering expertise, vendor management skills, and hands‑on involvement across the full project lifecycle, from concept through commissioning and qualification.

Key Responsibilities
Technical Leadership & Project Execution

Technical lead for assigned equipment or process area within a capital project.

The primary technical contact between internal stakeholders and equipment vendors.

Translate user and process requirements into clear technical specifications and design expectations.

Partner with the Project Manager to align on timelines, risks, and technical deliverables.

Lead the development and review of engineering documentation, including User Requirements Document (URS), Functional Specification Document (FDS), Hardware Design Specification (HDS), Design Review (DS) and Characterization documents.

Prepare and execute characterization challenges through experiments to evaluate critical parameters and their impact on product quality and process robustness.

Support FAT and SAT together with the Validation team.

Oversee the installation, testing, and commissioning of equipment systems to ensure proper functionality and performance.

Perform all tasks with due care and attention ensuring compliance with Good Manufacturing Practices and company requirements, policies and procedures.

Support a safe working environment by complying with environmental health/safety practice, rules and regulations.

Manage technical interactions with equipment suppliers throughout design and build phases.

Review and challenge vendor designs to ensure alignment with requirements and standards.

Monitor vendor progress, identify risks, and drive issue resolution.

Qualifications
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge or the equivalent:

BS degree or higher in Mechanical Engineering (or equivalent experience).

6+ years of relevant work experience with 4+ years in operations or manufacturing environment, preferably in automated device assembly, labeling and packaging processes. Pharmaceutical company is a plus.

Strong knowledge of equipment design, installation, and maintenance processes and proven experience working with external vendors and managing technical deliverables.

Hands‑on experience with commissioning activities.

Direct experience with regulated environment (e.g. GMP, OSHA, EPA).

Occasionally work outside office hours and travel abroad.

Effective communication skills in English (written and verbal).

Proficiency with standard engineering and office tools (e.g., MS Office).

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