Engineer Senior, Biotech Manufacturing and Process Equipment; JP

Position: Engineer Senior, Biotech Manufacturing and Process Equipment (JP13074)
Location: West Greenwich
Job Title: Engineer Senior, Pharmaceutical Manufacturing and Process Equipment (JP13074)
Location: West Greenwich, RI. 02817
Business Unit: Facilities and Equipment Drug Substance Supply
Employment Type: Contract
Duration: 1+ years (with possible extensions)
Rate
: $44 - $48 / hr.
Posting Date:8/1/2024.

• Notes: Fully onsite. Up to 20% domestic travel for cross site training

3 Key Consulting is hiring! We are recruiting an Engineer Senior, Biotech Manufacturing and Process Equipment for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
This engineering position supports manufacturing activities associated with manufacturing process equipment at our client’s Rhode Island facility. The engineer works in partnership with the maintenance, Project Management, Engineering Technical Lead, and manufacturing to develop, improve and oversee the operation and reliability of equipment. The Engineer role will provide direct engineering technical support as follows:

• Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment systems.
• This may include development of reason for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
• Support Lean Transformation and Excellence in Operations process improvement by leading, supporting, and documenting improvement opportunities to reduce cost, improve safety/quality or improve speed.
• Be individually accountable for the verification deliverables on key capital projects.
• Advising and coordinating equipment maintenance as vital to ensure systems are in proper working order.
• Provide oversight for verification deliverables developed by outsourced/contract verification staff.
• Develop commissioning and function test plan for any equipment modifications and acquisition.
• Ensure safety during commissioning, validation, maintenance and manufacturing activities.
• Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable. Act as a liaison between Engineering and Manufacturing during project planning, execution, and closeout.

• Monitor systems to identify performance risks and implement risk reduction strategies.
• Providing problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis involving multidisciplinary site teams and implementation of corrective/preventive action.

• Support new product/technology introductions by performing engineering assessments, implementing equipment modifications and supporting engineering runs.

• Ensure systems are installed and operating safely align with pertinent environmental health/safety practice, rules and regulations.
• Provide ad hoc technical support and guidance for manufacturing and maintenance.
• Provide coaching and guidance to project teams and engineers on the CQP process and risk-based approaches to commissioning and verification.
• Assist in developing and maintaining metrics.
• Full time onsite support in required.
• Work schedule flexibility to support 24/7 operations, requiring occasional after-hours engineering coverage as required from time to time.
• Candidate must be self-driven and work independently.
• Must have pharmaceutical process manufacturing experience (not biologics)

Top Must Have Skill Sets:

• 4 to 6 years Engineering and technical background on process equipment in pharmaceutical industry
• Local to West Greenwich, Rhode Island
• No work gap more than 3 months
• Demonstrated ability to work independently with minimal supervision
• Demonstrated to be motivated to take on new challenges
• Demonstrated ability to solve complex problems by being detail oriented and data driven
• Has shown cross functional collaboration with multidiscipline functions such as process development, engineering, automation, maintenance and management

Day to Day Responsibilities:
The Engineer role will provide direct engineering technical support as follows:

• Identify, support, and/or lead implementation of engineering-based improvements or

• upgrades to the…