- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
- Our company’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain company's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
- Our company has a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.
- A high level of initiative, energy and motivation are key role requirements, as well as excellent organizational skills.
- Leading a team of automation engineers in the support of site operations across a wide variety of technology platforms.
- Preparation and management of operating budgets to support site operations.
- Representation of automation at change control reviews and site quality review teams
- Definition and management of the automation philosophy for the site
- Defining automation strategies for future projects
- Ensuring the site automation systems are maintained in a GXP state
- Identification and execution of continuous improvement projects within Automation, for the benefit of the site
- BS or MS in Chemical, Electrical, or Mechanical Engineering from an accredited university
- Minimum of 10 years’ experience with the design, installation, startup, and servicing of process control systems.
- Minimum of 5 years of experience in pharmaceutical environment including regulatory requirements associated with 21 CFR Part 11 and supporting validation of control system equipment.
- Prior experience with controls systems supplied with skidded equipment utilized in fermentation, cell separation and recovery, filtration, CIP, and clean utilities preferred.
- Prior experience in the leadership of teams is preferred.
- Knowledge and Experience of the following systems would be an advantage:
- SIMATIC S7
- OSI PI
- Infor CMMS
- MS Office Software Applications (Word, Excel, PowerPoint, Project, Visio)
- Strong organization, interpersonal, oral and written communication skills.
- Proven ability to work collaboratively with cross-functional teams
- Proven ability to lead and influence decision-making.
- Position will require internal interaction with manufacturing, quality assurance, validation, facility operations & maintenance, project management, and manufacturing sciences.
- External interaction with equipment vendors and suppliers as necessary for projects.
- Position will lead a group of 10+ automation engineers across a number of technology platforms.
- Position will indirectly oversee, mentor or coach other personnel.
- The position may require supervision of outside vendors, consultants or design personnel.