Engineer II
Tenaya Therapeutics, Inc., United States
Job Description
About Tenaya Therapeutics
Tenaya Therapeutics is a publicly held biotechnology company committed to a bold mission: to discover, design, develop and deliver curative therapies that address the underlying drivers of heart disease. Founded by leading cardiovascular scientists from Gladstone Institutes and University of Texas Southwestern Medical Center (UTSW), we are advancing a deep and diverse pipeline that includes both gene therapies and small molecules.
Tenaya is headquartered in South San Francisco, California, USA, with a team that comprises over 110 employees. Inspired by the majesty of Tenaya Peak in Yosemite National Park, our name represents the tenacity of our team in reaching our ultimate peak the delivery of new therapies for heart disease to the patients who need them.
For more information, please visit www.TenayaTherapeutics.com and follow us on LinkedIn.
Diversity amp; Inclusion is a core Value for Tenaya Therapeutics, and we encourage those from under-represented communities to apply.
The Role
The Engineer is responsible for providing engineering support primarily to the Quality Control group, followed by the Manufacturing and Facilities groups. This individual shall have a strong understanding of GMP’s and experience providing engineering support in a gene/cell therapy, pharmaceutical, or biotech facility.
This individual will be required to develop an understanding of current and future processes and translate these into the facility and equipment requirements. The scope of this position includes SME support of
- Maintenance and Calibration
- Process Engineering
- Automation Engineering
- Engineering Programs, Business, and Operational Support Services
Primary responsibilities include ensuring the quality control equipment and processes runs in a compliant manner. Investigate any equipment or process deviations and develop corrective actions to prevent reoccurrences. Work collaboratively with staff for the development of user requirements and functional specifications
Specific responsibilities include:
- Owns and manages changes to the process equipment
- Maintains equipment in a validated state
- Problem solve any technically related issues impacting production
- Prepare contingency plans and logically work through complex issues
- Develop and implement equipment reliability and maintenance strategies that are compliant, effective, and cost appropriate
- Develops project objectives working with user requirement and business plans
- Determines project specifications and cost-effective technology’s to be implemented
- Establish equipment specifications in standard documentation User Requirements (URS)
- Functional Specification (FS) and Detail Design Specifications (DDS)
- Review and approve critical documentation such as SOP’s and URS’s
- Participate in all FDA and internal audits of the manufacturing facilities and process equipment and respond to any observations received
- Responsible for maintaining quality standards to meet GMP requirements, CFR’s and internal company policies
- Participate in new product introduction
- Drive operational excellence and continuous improvement
Requirements
Required Education, Skills and Experience
- Minimum B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field
- A minimum of 3 years of experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations
- Experience in the manufacture of gene therapy products, medical devices, instruments, or biotechnology
- Experience in the use and maintenance of analytical equipment
- In-depth knowledge of FDA regulations and GMP systems
- Applied knowledge of Quality by Design, six sigma, and operational excellence tools in creating efficient and high-quality processes and end products
- Experienced in authoring cGMP documentation including SOPs and Batch records.
- Proven ability to make risk-based decisions in a complex/dynamic environment in a timely manner.
- Open minded attitude that start-up team environments require an assortment of skill and a high level of commitment
Benefits
We offer a dynamic start-up environment and a collaborative, passionate team that is focused on a compelling vision and mission.
We offer a competitive salary and stock options. Excellent medical and non-medical benefits. Paid vacation, sick time and holidays.
State-of-the-art, built-to-suit office and lab space, part of a larger cluster of biotech companies, with amenities that include a bowling alley and onsite gym.
Shuttle service to/from Caltrain, BART and the S