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20 days old

Sr. Project Engineer

Kelly Services
Indianapolis, IN 46202
**Sr. Project Engineer**


**Job Description:**

Kelly is seeking a Senior Project Engineer with experience in the design and development of commercial manufacturing processes to join our team in Indianapolis.


You will be:


- Joining an extraordinary team driven to impact the lives of cancer patients globally


- Accelerating the development of life changing radiopharmaceuticals


- Working in a state-of-the-art facility for the production of next-generation cancer therapies


We are an innovative, high-performance company focused on a hard problem: creating new cancer therapies that are more effective and have fewer side effects than traditional treatments. Our products are targeted radioligands, a technology that hold significant promise to treat cancer. Our company is growing rapidly: we're enrolling a phase 3 clinical trial for our novel radioligand based prostate cancer treatment, have an exciting pipeline of next-generation oncology products, as well as an 80,000+ sq ft state-of-the-art manufacturing center.


**TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN THE USA.**


Reporting to the Senior Director Process / Plant Engineering, the Senior Project Engineer is responsible for the design, procurement and on-boarding of highly specialized process equipment for GMP manufacturing activities. The Senior Project Engineer is an expert in the development and optimization of commercial manufacturing processes, including manufacturing, filling, assembly, inspection, and packaging. The position will utilize a wide range of engineering disciplines to onboard new technologies and support advancement from construction to commercial GMP operations.


**LOCATION:** Indianapolis


**In this role, you will be expected to:**



+ Oversee the design, procurement and on-boarding of specialized process equipment

+ Partner with Process Development and CMC Teams to develop commercial product manufacturing processes for radioactive small-volume parenteral drug products

+ Lead the design, development, optimization and integration of semi-automated and automated equipment intended for manufacturing, aseptic fill/finish operations, inspection, and packaging

+ Lead the design of process flows from concept generation through process validation and launch

+ Apply knowledge and expertise to conduct and interpret development studies (e.g., FMEA, feasibility, design verification and validation)

+ Lead and/or support the development and execution of FAT, installation, commissioning and validation of equipment

+ Work closely with internal stakeholders, consultants and external partners to create user requirement specifications, conceptual designs and detailed design outputs

+ Serve as the primary point of contact for external equipment vendors and ensure build-out occurs on schedule and meets corporate objectives

+ Support IT system integration to ensure appropriate data flow and data integrity during the manufacturing process

+ Prepare project estimates for equipment design, procurement, installation, qualification, and other related costs. Prepare project forecasts and schedules

+ Proactively identify program and technical risks, and generate mitigation plans


**Requirements**


+ Minimum Bachelor's degree in Engineering or Science required; focused in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering or Chemical Engineering. Advanced Degree preferred.

+ Minimum 6 years of relevant Engineering experience in a GMP environment, preferably in the pharmaceutical industry

+ Experience working in a FDA regulated operation with an extensive knowledge of cGMPs

+ Experience working with small-volume parenteral, sterile unit-dose filling, or radiopharmaceutical drug products preferred

+ Excellent verbal and written communications skills with technical and cross-functional audiences

+ Manufacturing process development or operations experience with process flow design, manufacturing line design, development and implementation, process automation, and software validation

+ Process DOE execution (i.e., manufacturing process optimization, assembly process development/characterization/qualification)

+ Proficient in validation requirements for new manufacturing equipment and process changes

+ Understanding of vision-based inspection methods

+ Experience with FMEA, process flow development, applying the design control process, equipment development and external manufacturing & supplier management


Requires up to 25% travel


**Benefits:**

Health Care Plan (Medical, Dental & Vision)

Retirement Plan (401k, IRA)

Life Insurance (Basic, Voluntary & AD&D)

Paid Time Off (Vacation, Sick & Public Holidays)


\#P1


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-09 Expires: 2022-10-10

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Sr. Project Engineer

Kelly Services
Indianapolis, IN 46202

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