TriLink BioTechnologies is actively responding to the COVID-19 pandemic through vaccine and diagnostic programs.
TriLink BioTechnologies is seeking a Director of Engineering. As part of the Senior Leadership team at TriLink, this individual will oversee Facility, Equipment, and Process Engineering, Automation Engineering, Capital and Engineering Project Management, as well as Maintenance, Calibration, and new equipment Validation. The leader will ensure GMP operations and enforce ISO practices in Engineering Operations, manage budgets, oversee routine maintenance and calibrations programs, oversee site risk management, and ensure proper facility operation and expansion. This role will work closely with Manufacturing, Quality, R&D, PD, and IT on strategic projects including M&A, TriLink capital management, computer systems/ controls, maintain site facility, assist with growth and layout strategy, to include strategic facilities requirements support new product and process development
- Provide stable and effective leadership, support, and direction to the engineering team, creating an organization dedicated to innovation, effectiveness, safety, and flexibility
- Participate and lead, when required, key strategic initiatives, including facilities planning and M&A/integration. Work with key senior leadership and outside resources/consultants to achieve corporate goals
- Hire and retain key talent to meet strategic and tactical goals and KPI’s
- Develop policies and oversee key routine maintenance, calibration, validation, and repairs
- Oversee security and conduct site inspections. Respond to emergencies as needed
- Work with senior leadership to identify opportunities to reduce operating costs, enhance margins and improve production efficiencies
- Ensure compliance with federal, state, and local regulations and laws
- Required BS Engineering
- 12+ years of increasingly responsible engineering, automation, maintenance, and validation operations in an ISO or GMP operational environment
- Experience as a cross-functional leader with demonstrated results in building out facilities to support new product and process introductions
- Ability to establish and lead the Site Capital Committee inclusive of the development of site operational capital budget to support a total site engineering solution
- Knowledge of construction with an emphasis on understanding ISO and GMP requirements for manufacturing raw materials, API (Drug Substance), and Diagnostic products.
- Knowledge of budgeting and accounting practices
- Ability to establish and maintain effective working relationships with those contacted in the course of work
- Ability to maintain awareness of new and changing techniques and technology in facility and equipment systems
- Experience with 21 CFR 820, ICH Q7, ISO 9001, and/or ISO 13485 requirements a plus
- Strong multi-tasking abilities to complete activities in a fast-paced, deadline-driven environment
- Results-driven self-starter
- Ability to manage stress and balance competing demands in a high throughput environment
TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefit package including medical, dental, vision, LTD, and a retirement plan.
TriLink is an EEO Employer.