Sr. Engineer, Process & Automation

Location
Austin, TX, USA
Posted
Nov 11, 2020
Ref
173940
Required Education
Bachelors Degree
Position Type
Full time
Location:

Austin, TX

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:

The Sr. Process & Automation Engineer is a Subject Matter Expert (SME) with demonstrated advanced knowledge and understanding of Biologics Process Engineering & Automation design practices and procedures 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 impact and inform 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 process contacting equipment, CIP/SIP, clean utilities and process automation platforms. The Sr. Process & Automation Engineer will be part of a dynamic group of engineers who will be responsible for capital and expense project delivery, process trouble shooting, root cause analysis and providing optimization strategies for process support equipment within multi-product, FDA regulated cGMP facilities.

This role will be a major contributor during the transfer of new processes and technologies to the Austin Manufacturing and R&D facilities. This role serves as subject matter expert for clean utilities, HVAC, cleaning (CIP/COP), sterilization (SIP, VHP) and single-use systems. Duties will include the troubleshooting of validated processes, commissioning and validation support and providing technical assessments for process deviations and investigations. Develop and execute engineering tests, FATs, SATs and 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 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
  • Provide technical expertise for the commissioning and validation of processes, process equipment and associated utilities through teams composed of cross functional SMEs.
  • 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 process health through process monitoring, trouble shooting of processes and process equipment.
  • Specify process control strategies and oversee process automation system implementation and continuous improvements
  • Primary point of contact for all process equipment related troubleshooting and change control
  • Own and maintain design and specifications for equipment and instrumentation
  • 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 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.
  • 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
  • Provide SME troubleshooting expertise/support on projects or significant process related technical issues in upstream, downstream, fill/finish, and various analytical methods
  • Provide support 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, Biochemical or Mechanical Engineering, Biotechnology, Biochemistry, 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 Emerson DeltaV - Syncade, Rockwell, Allen Bradley, and Siemens Simatic / Win CC
  • Prior experience in biological/viral commercial GMP facility
  • Validation experience related to equipment, clean utility and process systems, including requirements for documentation and testing.
  • Demonstrated experience implementing ISA 88 and ISA 95 batch and MES standards for process automation
  • 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.
  • Thorough knowledge of biopharmaceutical manufacturing, process equipment and supporting
  • 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