Title : Senior Engineer

Location: Rhode Island

Duration: 12 Months Contract with possible extension

Description:

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.

• 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

Preferred Qualifications / Skills / Experience

• Bachelor’s degree in chemical or other Engineering fields

• 6 years' of 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

Must Haves:

1. 4 to 6 years Engineering and technical background on process equipment in pharmaceutical industry

3. No work gap more than 3 months

4. Demonstrated ability to work independently with minimal supervision

5. Demonstrated to be motivated to take on new challenges

6. Demonstrated ability to solve complex problems by being detail oriented and data driven

7. Has shown cross functional collaboration with multidiscipline functions such as process development, engineering, automation, maintenance and management

Rupalim Dutta

Team Lead

rupalimd@aditiconsulting.com

(650) 376-0819