Job Description

This role is responsible for leading site and network projects to support the Bioproduction Group (BPG) growth initiatives. Reporting to the Sr. Manager of Engineering, this includes responsibility for a cross-functional/multiple-disciplined team reporting to this position, influencing and generating support from other functions and sites, identifying acceleration opportunities, delivering on all phases of assigned projects (initiating/due diligence, business case creation, planning, executing). The role will leverage in-depth project management and leadership skills to help drive company and global operations long range strategies.

This role is accountable for the overall operational effectiveness of analyzing site capacity needs, managing project approval process with executive leadership, managing full cycle capital process, project manage execution and delivery to condense timelines. The role requires candidates to have the ability to interact with all levels of the organization and requires strong communication and leadership skills coupled with extensive project management experience and understanding. Ideal candidates will have a track record of delivering results, creative and innovated thinking and the ability to translate ideas into action.

Essential Functions

* Lead a team to overall project management, budget, schedule management, construction management, start-up, conceptual phases, project close-out, scope development, cost estimation, system design, equipment sizing and selection, procurement, installation, check-out, and validation (IQ/OQ & PQ).
* Analyzing site capacity needs and priorities projects to maximize benefits
* Provide innovative technical solutions required to meet business objectives with emphasis on productivity.
* Provide support to capital planning process, new product development, and process automation.
* Perform validation of equipment, automation systems, data collection systems, and processes for the manufacturing operations.
* Preparing protocols, perform testing, collect samples, analyzing test results, and preparing summaries.
* Provide support to other sites with harmonization activities to enable product transfers and equivalency between the sites.
* Provide technical assessment and validation review/approval for engineering and process changes.
* Present to executive leadership CAPEX and OPEX requirements supporting due diligence and financial analysis
* Develop cross functional relationships across the organization to drive efficiency in the project approval and execution
* Drive organizational effectiveness in direct labor (DL) and indirect labor (IDL) to support project plans
* Drive improvements in business metrics and/or manufacturing processes
* Facilitate issue resolution and/or appropriate escalation
* Be a solid business partner for operations leadership team

Education:

Requires a bachelor2019s degree in an engineering discipline and 5 years equivalent work experience. Project Management experience (certification preferred) and/or MBA/Advanced degree a preferred.

Experience/Requirements:

* Requires a minimum of 5 years of relevant experience in a complex manufacturing environment manufacturing, distribution and/or project management.
* Direct people leadership experience is a plus.
* Background in Chemical or Mechanical Engineering or related industry experience is preferred including a minimum of 10 years of equipment selection experience in a cGMP environment with increasing levels of responsibility for a wide range of projects, including design, validation, and operation of large scale manufacturing, and automation systems.
* Must be able to work independently as well as with teams, organize and manage projects by defining milestones, budgets and schedules; prepare regulatory summaries and present validation to regulatory authorities.
* Must have a thorough knowledge of manufacturing processes, quality systems, engineering design and start-up fundamentals, regulatory agency expectations and industry trends.
* Experience with regulated environments (i.e. cGMP, FDA, ISO 13485, OSHA, EPA) is essential.
* Candidates should have experience in pharmaceutical/biotech processes, and familiarity with documentation in a highly regulated environment.
* Strong knowledge of project management tools
* Analytical and detail-oriented with strong Excel & PowerPoint skills
* Excellent communication skills
* Customer-centric with the ability to build and drive strategic customer relationships, both internally and externally, national and internationally
* Experience & demonstrated executive-level reporting and presentations
* Solutions oriented with a forward-focused mentality; see problems coming and develop strategic solutions
* Must be a creative problem solver and have the ability to function in a rapidly changing environment
* Ability to influence others and partner cross functionally
* Demonstrate Thermo Fisher Scientific values - Integrity, Intensity, Innovation and Involvement
* Demonstrate Role Model Leader Characteristics: Embody the 4-I values, Delight customers, communicate openly and honestly, Focus on growth and Champion employee development
* Drive use and improvement of global project management processes
* Up to 20% travel required