Sr. Engineer, Facility and Plant Engineering

Location
Austin, TX, USA
Posted
Sep 13, 2020
Ref
173962
Required Education
Bachelors Degree
Position Type
Full time
Company Description:

Molecular Templates is a clinical stage biopharmaceutical company focused on the discovery and development of differentiated, targeted, biologic therapeutics for cancer. We believe our proprietary biologic drug platform technology, referred to as engineered toxin bodies, or ETBs, provides a differentiated mechanism of action that may address some of the limitations associated with currently available cancer therapeutics. ETBs utilize a genetically engineered form of Shiga-like Toxin A subunit, or SLTA, a ribosome inactivating bacterial protein, that can be targeted to specifically destroy cancer cells. Additional information about Molecular Templates can be obtained at www.mtem.com.

Position Overview:

Sr. Engineer, Facility and Plant Engineering is a Subject Matter Expert (SME) with demonstrated advanced knowledge and understanding of Plant Engineering, HVAC, Utilities and Building Automation design practices within the biopharmaceutical cGMP environment. The incumbent will provide leadership and mentoring for more junior engineering staff as the department continues to grow. This role is a key position for MTEM and the successful candidate will significantly improve our bioprocesses used to produce engineered toxin bodies. This is an exciting and dynamic opportunity for you to contribute to the development of new principles and concepts and to be challenged and lead change from an engineering perspective.

This role provides technical support for the manufacturing facility, including the design and specification of plant utilities and building management platforms. The Sr. Engineer will be part of a dynamic group of engineers who will be responsible for capital and expense project delivery, equipment & Utility trouble shooting, root cause analysis and providing optimization strategies for process support equipment within multi-product, FDA regulated cGMP facilities.

This role serves as subject matter expert for plant utilities including HVAC, Refrigeration and Building Management. Develop and execute engineering tests, FATs, SATs, commissioning test plans and train operations staff on new/revised operating procedures. Identifies equipment specific best practices and performs gap analysis between MTEM and industry best practices.

Job Responsibilities will include:
  • Serve as SME on Facility Engineering Design and Construction for drug substance Biologics manufacturing within MTEM Facilities & Engineering, sharing best practices, technical know-how and adding significant value to the group
  • Provide technical expertise to support process tech transfers and/or expense/capital projects through budget development, schedule development, resource planning, design, construction, commissioning and qualification activities
  • Champion and foster a positive safety culture in which we strive for zero workplace injuries, and actively contribute to continuous safety improvements
  • Provide technical leadership to monitor physical plant health through process monitoring and system reliability analyses
  • Specify process control strategies and oversee process automation system implementation and continuous improvements
  • Participate in gap analyses and risk assessments to support process tech transfers.
  • Author tech transfer related projects plans, assessments, and process validation protocols
  • Review and provide recommendations on design drawings, which may include PFDs that incorporate mass or energy balances and P&IDs, which include all line sizing, instrumentation and control philosophies.
  • Interact with vendors concerning contracts of critical financial value and select vendors based on key performance criteria.
  • Develop, manage and integrate key aspects of critical projects such as budget, schedules, resource planning
  • Generate controlled documents to support the start-up, operation, validation and maintenance of equipment and complex systems.
  • Provide key input into the validation of process equipment and associated utilities. Direct manufacturing and operations staff in the execution of validation protocols.
  • Primary point of contact for Facility and Utility equipment related troubleshooting
  • Owns and maintains the design and specification for equipment and instrumentation
  • Execute technical and scientific projects and initiatives including study plan and execution, writing technical reports, data analysis and interpretation to support development and manufacturing activities
  • Ensure quality and effectiveness of key results of major projects through sound design, early risk assessments, and implementation of effective risk mitigation strategies
  • Respond technically for quality system responsibilities: process-related investigations; product impact assessments, change control and CAPA
  • Participate as technical expert in site regulatory inspections as needed

Qualifications:
  • BS/MS in engineering discipline preferred Chemical or Mechanical Engineering, or related field 5+ years' experience in upstream or biologics process development, technology transfer, pilot plant, or manufacturing support.
  • 5+ years applicable equipment and process system experience.
  • Advanced knowledge of Biologics Process Engineering Design and Construction
  • PE licensure is preferred
  • Experience in the selection and design of leading industrial control systems including Siemens Desigo, Rockwell, Allen Bradley, and Siemens Simatic / Win CC
  • Prior experience in biological/viral commercial GMP facility
  • Validation experience related to equipment, utility and process systems, including requirements for documentation and testing.
  • Thorough knowledge of cGMP guidelines, experience in generation of controlled documents and extensive experience in equipment start-up and validation.
  • Excellent communication skills, both written and verbal.
  • Skill in listening to and understanding others' points of view and articulates tactfully and respectfully one's own perspective orally, in writing, and in presentation


Reporting Structure:

This position reports to Sr. Director, Facilities & Engineering.

Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries and benefits.

Molecular Templates Inc https://mtem.isolvedhire.com