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5 days old

Process Engineer

Kelly Services
St Louis, MO 63103
Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting contract opportunity with one of our leading clients!


**Title:** Process Engineer


**Location:** St. Louis, MO


**Duration:** 6 months + (possible contract to direct)


**Overview**


+ Sr Process Engineer - Biologics Pharmaceuticals

+ Lead process engineering, operational excellence and capital projects related to the manufacturing of active pharmaceutical ingredients, with a focus on Cell Culture.

+ Lead projects independently, or as the leader of a cross-functional team.

+ Extensive involvement in Engineering from conception through design; during equipment specification, startup, and validation as necessary for the projects.

+ Lead, execute and coordinate the project activities of the internal project team and any other necessary resources, including but not limited to; outsourced engineers and designers


**Responsibilities**


+ Manage process engineering projects from conception through startup.

+ Evaluate, develop, and manage the design and development of process-based engineering projects.

+ Analyze and propose solutions to technical problems; considers alternative projects.

+ Collaborates with Manufacturing, Maintenance, Quality, EHS, and Financial organizations to develop project scopes, schedules, and cost estimates.

+ Responsible to develop the project scope, budget and schedule into a Capital Appropriations Request (CAR, application for approval of funds) for capital projects.

+ Coordinate internal/external validation resources to ensure project milestones are achieved.

+ Maintain cost and schedule control on assigned projects from initial design through successful manufacturing of quality products.

+ Ensures Certification through commissioning, validation and qualification of projects and current manufacturing operations.

+ Advise Site Leadership on best courses of action on projects, technical matters and project economics. Provide regular communication up and down organization on status of projects.

+ Represents Patheon in contracts with outside vendors, contractors, engineers, regulatory authorities, and consultants on a frequent basis during execution of a major project.


**Required Qualifications**


+ Bachelor of Science degree in Engineering required. Chemical, Electrical or Mechanical Engineering preferred. Civil, Industrial or other Engineering field acceptable with relevant work experience.

+ 7+ years of Process Engineering/Project Management experience in the pharmaceutical manufacturing (or similar) industry.

+ Solid knowledge of global current Good Manufacturing Practices (cGMP) in active pharmaceutical ingredients and/or finished pharmaceutical manufacturing.

+ Knowledge and experience in a regulated environment to ensure regulatory compliance is achieved. GMP experience is preferred.

+ Familiar with upstream and downstream bioprocess operations and equipment.

+ Experience in managing complex engineering projects through cross-functional teams.

+ Experience in critical engineering tasks; forecasting, specifications, design guidelines, etc.

+ Proficient in Microsoft Project, Visio, Trackwise and Documentum software


**Preferred Qualifications**


+ Validation experience in a pharmaceutical environment is desired.

+ Formal Project Management training and certification such as PMP, is preferred.

+ Ideal candidate has cell culture experience going form biologics to product

+ Active participation in industry organizations such as ISPE is a plus.

+ Experience, training and certification in Operational Excellence (Six Sigma, Lean) is preferred.


**Competencies Required**


+ Must possess a high level of proficiency in a technical core competency.

+ Excellent verbal and written communications skills with the ability to build and drive cross-functional teams.

+ Strong customer focus and drive for results with strong problem-solving abilities.

+ Capable of setting clear priorities, organizing work, and making quality decisions in a fast-paced business setting.

+ Define process requirements and establish project design criteria based on engineering analysis and evaluation. Prepare detailed functional specifications.


**Additional Information**


+ 5% - 15% Travel may be required

+ Risk of exposure to chemicals in a plant environment.

+ Work around biopharmaceuticals, chemicals, plant utilities equipment and at construction sites.


**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please contact Taryn Carbone ( taryn.carbone@kellyservices.com ) for immediate consideration.


**Why Kelly** **** **?**


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**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/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. 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 is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2021-02-19 Expires: 2021-03-22

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Process Engineer

Kelly Services
St Louis, MO 63103

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