Sr Principal Associate – Process Engineering - OSD

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

-Responsibilities

Provides technical expertise to Dry Product Operations (DPO) and/or Spray Dryer Dispersion (SDD) and/or site projects delivery ensuring compliance with cGMPs, HSE guidelines and regulations, company standards and business practices. The primary areas of technical support include technical advice and technical leadership (process and equipment), manufacturing and business process improvements, compliance with business systems, and supports and leads technical development of his/her juniors.

Key Objectives/Deliverables:

· Provide DPO and/or SDD technical expertise to lead/assist in the design and operation of efficient manufacturing processes.

· Contributes technically or lead and applies their scientific skill set toward problem solving, continuous improvement, optimization, and/or special projects. Use tools like FMEA, SPC, RCA, etc. Serve as technical expert in support of other teams and departments (TS/MS, Maintenance, Engineering, Quality, etc.).

· Provide technical oversight to less experienced engineers. Coach and mentor process engineers in aspects of fundamental engineering principles, including process understanding (both theoretical and practical), process capabilities/capacity, problem solving, engineering design, and project management and improvements. Provide coaching and direction on technical matters to the assigned team or project.

· Oversee process and equipment performance in areas under responsibility and assure they adhere to business and compliance requirements. Stay abreast of the latest technology trends, applications, and compliance requirements.

· Participate in the selection/hiring process of technical resources.

· Promote consistency in the application of Engineering principles among technical resources.

· Identify training and development needs of technical resources (including self and others) and lead efforts to create opportunities for knowledge sharing (coordinating external/internal trainings, leading technical forums for knowledge transfer and sharing, etc.).

· Network Process Engineering solutions with other Lilly sites and technical resources (internal/external).

· Serve as author, reviewer, or approver of technical documents such as Qualification/Validation protocols, Change Controls, Deviation Investigations, Designs of Experiment, Technical Reports, Process Characterization Studies, Process and Equipment Reviews (AQMs, APRs, etc.) as needed.

· Provide support to the management of daily operations, including 24hr/7days technical support (call in assistance if necessary).

· Provide technical expertise for installation, operation, maintenance, and reliability of process equipment. Serve as liaison between maintenance, reliability, utilities, and automation and DPO and/ or SDD in general.

· Own the qualified state of their equipment and perform AQM according to the defined strategy.

· Oversee/lead/own Commissioning & Qualification (C&Q) strategies and execution for assets.

· Have holistic understanding of Process Validation (and associated equipment, facilities, and computer systems), assessment of significant changes, maintenance and other interventions, involvement with PM Plans and spare parts list.

· Assure safety processes (procedures, training, and equipment) are in place (i.e., LOTO, Line breaking, Machine Guarding, etc.).

· Review projects for “ergonomic concerns” in terms of ability to operate the equipment.

· Develop and maintain technical information of the process: operational procedures (Equipment/Process); drawings; system/component classification; user requirements; hazardous/non-hazardous waste information; material and energy balance; equipment safety information (safety parameters); process safety information; process models; capacity; etc.

Basic Qualification

• Bachelor’s degree in Engineering – Chemical, Mechanical
• Experience: 6-8 years of pharmaceutical manufacturing experience in OSD, SDD or chemical synthesis
• English language fluency

Additional Skills/ Preferences

• English required; Dutch preferred
• Ability to influence diverse groups and effectively manage relationships,
• Candidates should be open to work on Site full time and be available to support 24/7 operations when needed
• Thorough technical understanding of the quality systems and regulatory requirements,
• Experience in root cause analysis, FMEA, etc

Additional Information

• Overnight travel is required
• Flex hours possible
• Requires ability to stand for long periods of time, frequent ladder or stair climbing. Walk -through on a construction environment (e.g., obstacles etc.), climbing stairs, bending and kneeling down, etc
• Fixed-term contract (12 months); Intended as a permanent role.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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