Apply to Engineer Senior, Biotech Manufacturing and Process Equipment (JP13074)

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 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.
Up to 20% domestic travel for cross site training
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

Basic Qualifications:
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree (mechanical or chemical engineering) and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience

Preferred Qualifications:

Bachelor’s degree in chemical or other Engineering fields
6+ years' relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment

Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and
familiarity with GMP quality systems/processes such as change control, nonconformances,
corrective and preventative actions, and qualifications/validation.
Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production
facility equipment/systems such as cell culture reactors, chromatography, filtration, as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, etc.
Ability to analyze problems, develop and propose engineering solutions in a scientific
manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects
Understanding of the execution process of capital projects in a GMP and/or non-GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation
Understanding of safety requirements working in a Biopharmaceutical Production facility.
Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration
Phenomenal teammate prepared to work in and adopt a team based culture that relies on collaboration for effective decision-making
Strong leadership, technical writing, and communication/presentation skills

Why is the Position Open?
Supplement additional workload on team

Red Flags:

No work experience
No engineering or technical experience
No collaboration experience
No work gap of more than 3 months

Interview Process:
Webex panel.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.