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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

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