Apply on Employer Site

Endo · 11 hours ago

Sr. Manufacturing Engineer

Hobart, NY (Pharma) - USA036

Full-time

Onsite

Mid, Senior Level

$76K/yr - $122K/yr

4+ years exp

Mallinckrodt Enterprises LLC is a healthcare company committed to improving lives through quality and safety. The Sr. Manufacturing Engineer will develop project scopes, schedules, and budgets for new and upgraded equipment and systems, ensuring successful project execution within budget and on schedule.

Pharmaceuticals

Comp. & Benefits

Responsibilities

Works with respective functional group in developing and implementing project scope and cost estimates

Works with respective functional group(s), incorporating business data (sales, financial, etc.) where appropriate, to generate a compelling project justification and application for approval of funds

Works with all internal stakeholders to develop User Requirement Specifications (URS) for equipment

Assists Validation Department with Developing, reviewing, approving, and executing IQ, OQ, PQ, FAT, SAT, equivalency, change in kind documentation as required in the pharmaceutical environment while ensuring compliance to all applicable standards related to the technology including federal, state, and local regulatory codes, as well as customer, operations, and corporate requirements

Execute change management process documentation

Manage the work of project contractors/vendors

Ensure proper end users training for all projects

Writes and executes Risk Analysis (i.e. FMEA and Fishbone Diagrams) and Engineering Change Orders

Utilizes continuous improvement methodology to improve internal processes

Writes/revises SOPs, User Requirement Specs, Functional Requirement Specs, Design Specs, Qualifications, etc

Provides engineering support to corrective actions and deviations by identifying root cause and offering solutions

When necessary, assist Maintenance Department in resolving high-level technical processing issues related to equipment operation

When assigned act as Engineering Department representative on Site wide teams, e.g. safety

All other duties as assigned

Qualification

Pharmaceutical manufacturing experienceRisk analysisProject managementAutoCAD interpretationFDA regulations knowledgeContinuous improvement methodologyOrganizational skillsVerbal communicationWritten communicationTeam collaboration