Senior Specialist, Engineering

MSD•Bahama, NC

3d•Hybrid

About The Position

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! The Senior Specialist, Engineer is a member of the Engineering team providing technical support within a new therapeutic manufacturing facility located in Durham, North Carolina. The new facility includes end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse. The candidate will be responsible/support the reliability, operation, and maintenance of HVAC, and clean utility equipment and systems (WFI, Clean Steam, HVAC, and CDA), utility equipment and systems (Boilers, Chillers, etc) to ensure proper functionality of manufacturing equipment such as washers, autoclaves, filling line, lyophilizers and isolators. The successful candidate will also develop Standard Operating Procedures (SOPs), Preventative Maintenance (PM) plans as necessary and responsible for supporting root cause investigations and change control activities.

Requirements

Bachelor Degree in Engineering, Science and 6 years experience or a Master’s Degree in Engineering, Science and 4 years experience in a production and/or calibration and/or maintenance background
Adaptability
Adaptability
Deviation Investigations
Engineering Process
Facility Management
Failure Mode and Effects Analysis FMEA
HVAC Systems
Identifying Customer Needs
Interpersonal Relationships
Lean Six Sigma Tools
Lockout Tagout
Manufacturing Quality Control
Pharmaceutical Microbiology
Plant Maintenance
Process Improvement Projects
Productivity Improvements
Project Coordination
Project Management
Regulatory Compliance
Regulatory Inspections
Root Cause Analysis (RCA)
Steam Generators
Strategic Thinking
System Maintenance
Technical Writing

Nice To Haves

Proficient in PI Processbook, Siemens BAS, and DeltaV
Project management, including change control and equipment qualification
SAP experience related to plant maintenance and spare parts procurement systems
cGMP experience in a sterile, bulk or finished pharmaceutical environment
Experience authoring PM/calibration job plans and management of spare parts
Mechanical functionality and reliability knowledge (asset management)

Responsibilities

Responsible for the maintenance and reliability of Clean Utility Equipment (e.g. HVAC, Clean steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems)
Leads deviation investigations for HEPA and HEPA system failures, ensuring events are well-investigated and well-documented, while meeting timing commitments
Manages small projects for equipment/maintenance-related improvements, including obtaining quotes, drawing/specification review/approval, and review of contracts
Interact with vendors and support project coordination activities like design reviews, and engineering assessments
Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units
Responsible for assisting in the identification, development, and implementation of new systems which enhance the operation and/or engineering processes.
Adapts and implements departmental plans and priorities based on division scorecard to address local business, service and operational challenges
Consults on an as-needed basis with next-level manager for newly identified priorities
Develops operating strategy from an Engineering / Maintenance perspective supporting site reliability initiatives
Oversee improvement projects and implementation of productivity enhancement initiatives.
Lead in the identification and implementation of process improvement projects, productivity initiatives and corrective actions while focusing on equipment uptime, minimizing cost and maintaining process consistency
Anticipates and interprets client and/or customer needs to identify solutions
Must be fully aware of requirement specifications from a qualification perspective (IC/OC, IQ/OQ, CRs, etc.)
Provide input to investigate deviations (both minor and major), with responsibility to interface with Operations, Maintenance, Automation, and Quality approvers.
As part of the deviation management role, present and defend investigations during regulatory inspections, as required.
Actively supports safety initiatives, including shop floor audits, lockout/tagout and Hazardous Energy Control Procedure updates
Works as a liaison between Engineering, Maintenance, Production and other Site Business Partner’s
Support daily meetings to facilitate flow of information up/down through the organization
Escalate issues as needed to ensure the right support/awareness is given to issues as they arise
Develop training material. Working as a subject matter expert (SME), provide necessary training for system maintenance.
Serve as a Subject Matter Expert during tours to provide area/process overview information to visitors/auditors upon request
Ensure inventory/purchase order transactions are complete, timely, and accurate
Recognize and communicate opportunities for cost savings

Benefits

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

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