HuntsvilleRecruiter Since 2001
the smart solution for Huntsville jobs

Engineering Project Manager

Company: Summit Biosciences
Location: Lexington
Posted on: April 8, 2021

Job Description:

The Engineering Project Manager is responsible for leading and managing all phases of engineering capital projects including conceptual design, budget development, scope development, detailed design, procurement, schedule management, installation, start up and qualification activities for strategic, troubleshooting, and operational projects for the organization. This position is also responsible for the development and/or technology transfer of new solutions and modifications to our existing manufacturing process systems to solve process problems, optimize equipment performance and reliability and to manage related budgets and timelines.

  • Lead projects to plan, organize, and manage activities to solve process & production problems, develop and implement process improvements, and implement new products into manufacturing while maintaining the highest quality standards and facilitating continuous improvement in product cost, asset utilization, cycle times, and equipment reliability.
  • Develop and lead strategic projects for process and plant improvements to increase efficiency and drive down costs.
  • Lead the design of facilities and equipment and the optimization of existing manufacturing processes to deliver FDA compliant production capacity on time and within budget.
  • Lead qualification activities to assure facilities, utilities and process equipment qualifications are performed to company standards.
  • Guide the specification and selection of manufacturing equipment/utility equipment and award architectural and engineering contracts based on comparative bids and analysis.
  • Assist with planning and executing capital plan for facility and production equipment related spending to assure production is in a position to meet new product development and product launch manufacturing requirements.
  • Leads projects such as; new equipment design and procurement, facility expansions, corporate level electronic systems.
  • Responsible for understanding the process requirements and how they impact equipment/utility/facility design.
  • Communicate with partners and clients to identify and implement any necessary equipment or capabilities for new projects.
  • Plan, coordinate and track the progress of all project phases.
  • Assure compliance with quality policies and procedures related to validation activities.
  • Promote cooperation and teamwork with all departments by open, candid communication and timely coordination.
  • Develop and execute engineering strategic plan with key elements including capacity, business continuity, technology, profitability, asset utilization, etc.
  • Help build a safety culture that strives for zero injuries through engagement and a focus on prevention and strong safety behaviors.
  • Responsible for scope, schedule, and budget on engineering capital projects.
  • Author user requirement specifications.
  • Author and track completion of change management.
  • Assist in the development of the engineering strategic plan/road map. Candidate Attributes
    • Exceptional organizational skills and attention to detail
    • Superior interpersonal and written communication skills and demonstrated ability to effectively communicate with all levels of the organization.
    • Extensive knowledge of cGMP regulations
    • Must be flexible, adaptable, self-motivated and able to work well independently and across teams and partners.
    • Ability to clearly and concisely articulate constraints in a quantifiable manner and identify alternatives to keep projects on schedule.
    • Ability to influence and negotiate skillfully through tough situations while maintaining good will and important relationships.
    • Ability to work in a lean, action oriented organization and demonstrate a strong work ethic.
    • Ability to identify the need for and implement change while inspiring confidence and enthusiasm within the team.
    • Ability to provide innovative, compliant ideas or alternatives that create value, including seeking new information and external insights. Qualifications
      • BS in engineering or relevant technical discipline
      • 10 years of experience in pharmaceutical engineering and/or validation related functions
      • Experience managing plant design, construction, commissioning, and validation projects.
      • Hands on experience in validation, utility/mechanical/electrical equipment troubleshooting and repair, and project management.
      • Excellent knowledge of validation principles including commissioning, IQ/OQ/PQs, Process validation, Cleaning validation, Computer Related Systems validation, etc.
      • Excellent working knowledge of cGMPs, OSHA compliance, HVAC systems and cleanrooms, automated pharmaceutical processing and plant utility equipment
      • Excellent technical writing, communication, and organizational skills
      • Experienced in financial and accounting principles/spreadsheets and Project Management.
      • Good interpersonal skills and the ability to work well in a team environment.
      • Experience with MS project or related software.

Keywords: Summit Biosciences, Huntsville , Engineering Project Manager, Professions , Lexington, Alabama

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Professions Jobs

Warehouse Associate
Description: Company: US0060 Sysco Nashville, LLCZip Code:37209Minimum Level of Education:High School or EquivalentMinimum Years of Experience:0-1 YearsEmployment Type:Full TimeTravel Percentage: 0OVERVIEW:We offer (more...)
Company: SYSCO
Location: Smyrna
Posted on: 04/12/2021

91S Stryker Systems Maintainer
Description: Stryker Vehicles are fast, highly-mobile combat vehicles used by the military to triumph on the battlefield. As a Stryker Systems Maintainer for the Army National Guard, you will be responsible for keeping (more...)
Company: Army National Guard
Location: Smyrna
Posted on: 04/12/2021

In-Home Solutions Technician
Description: The In-Home Services organization supports thousands of talented employees in 135 facilities delivering service solutions to customers in every zip code. Our installation technicians are leading the (more...)
Company: DISH
Location: Smyrna
Posted on: 04/12/2021

Petroleum CDL-A Company Truck Driver - Daily Home Time
Description: CDL-A TANKER TRUCK DRIVER JOBS br br Looking For A Better, More Stable Career Trade Up br br Florida Rock Tank Lines, a leading Southeast carrier is growing rapidly, offering CDL-A truck drivers (more...)
Company: Florida Rock & Tank Lines, Inc.
Location: Smyrna
Posted on: 04/12/2021

91D Power-Generation Equipment Repairer
Description: Since the Army National Guard uses a plethora of electronic systems, power is essential to success. As the Power-Generation Equipment Repairer, you'll supply the power to run virtually every aspect of (more...)
Company: Army National Guard
Location: Smyrna
Posted on: 04/12/2021

Description: Freight/Receiving 392464687 Smyrna, Tennessee, US, 37167 Position Purpose: Associates in
Company: The Home Depot
Location: Smyrna
Posted on: 04/12/2021

CDL-A Flatbed Truck Driver - Guaranteed Pay
Description: 40 Years Of Excellence LIMITED TIME SIGN-ON BONUS Extends through March 31, 2021 3,000 Sign-On Bonus For All Flatbed DivisionDrivers With 6 Months Of Verifiable Flatbed OTR, Boat or Log Hauling Driving (more...)
Company: Maverick Transportation, LLC
Location: Smyrna
Posted on: 04/12/2021

94F Special Electronic Devices Repairer
Description: The Army National Guard utilizes many forms of sophisticated equipment on and off the field. As a Special Electronic Devices Repairer, you will ensure that vital instruments and tools are meticulously (more...)
Company: Army National Guard
Location: Smyrna
Posted on: 04/12/2021

Description: br br Class A CDL Drivers - NEW PAY INCREASE Earn Up To 80,000 Per Year Weekend Home Time At MVL br It s the loyalty of our truck drivers that has contributed to our over 50 years of success (more...)
Company: Morgan Van Lines
Location: Smyrna
Posted on: 04/12/2021

88M Truck Driver
Description: As a Truck Driver in the Army National Guard, you are the backbone of military support. By transporting cargo and supplies, you'll play an integral role in keeping the Guard moving forward. In this role, (more...)
Company: Army National Guard
Location: Smyrna
Posted on: 04/12/2021

Log In or Create An Account

Get the latest Alabama jobs by following @recnetAL on Twitter!

Huntsville RSS job feeds