Job Description

Position Summary:

This is an exciting opportunity to be part of a new, fast-growing startup business unit within Thermo Fisher. The Project Engineering Manager is an expert in his/her field of expertise and is regarded as such within Thermo Fisher Microbial Manufacturing and the Thermo Fisher network. This critical position fulfills several essential roles; capital project portfolio management/execution, budget management, project engineering team leadership, general site technical leadership and personnel development. The Project Engineering Manager will collect and report data and KPIs to both internal and external stakeholders.

Key Responsibilities:

* Generates standard work plans/flows for engineering projects and ensures execution of all required work streams.
* Works with internal customers to scope, plan, and execute site-wide projects in order to meet financial targets.
* Understands, provides direction for, and/or executes bio-process equipment design, procurement, installation, commissioning and validation.
* Understands and provides direction on building design, laboratory design, automation infrastructure design, utility design and general site related projects.
* Consistently works to improve department workflow and standards.
* Works closely with Quality, Operations, Finance, Facilities and Site Management to execute projects without impeding day-to-day operations.
* Supports the management of site expense and capital budgets.
* Works with Procurement to develop equipment vendor relationships and assist in bid evaluation to ensure best pricing on new initiatives.
* Assists in generation and maintenance of the site master plan.
* Represents Thermo Fisher in contracts with outside vendors, contractors, engineers, regulatory authorities, and consultants on a frequent basis during execution of a major project.

Frequent Contacts:

Internal

* Department leaders and individual contributors
* Project leads

External

* Vendors

Minimum Requirements/Qualifications:

* Bachelor of Science degree in Engineering required. Chemical, Bio, or Mechanical Engineering preferred.
* Formal Project Management training and certification, such as PMP, is a plus.
* 6+ years of experience in the pharmaceutical manufacturing (or similar) industry. 8+ preferred.
* Solid knowledge of global current Good Manufacturing Practices (cGMP) in active pharmaceutical ingredients and/or finished pharmaceutical manufacturing.
* Solid knowledge of microbial or biologics manufacturing unit operations
* Validation experience in a pharmaceutical environment is preferred.
* Proficient with CAD and Microsoft Office applications. Microsoft Project is a plus.
* Must possess a high level of proficiency in a technical core competency.
* Active participation in industry organizations such as ISPE is a plus.
* 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.
* Startup experience a plus

Other Job Requirements:

* Adhere to OHS policies and procedures and ensure a safe and healthy workplace environment
* Experience in managing complex engineering projects through cross-functional teams.
* 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.
* Define process requirements and establish project design criteria based on engineering analysis and evaluation.
* Experience in critical engineering tasks; forecasting, specifications, design guidelines, etc.
* Experience, training and certification in Operational Excellence (Six Sigma, Lean) is preferred.
* 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.