United States onlyTogether with its wholly owned subsidiaries, DNA Genotek, Diversigen, and Novosanis, the OraSure family of companies provides its customers with end-to-end solutions that encompass tools, services, and diagnostics. Our teams play a role in empowering people to discover healthier lives by creating effortless tests, collection kits, and services.
It’s first-to-market, innovative products include rapid tests for the detection of antibodies to HIV and Hepatitis C (HCV) on the OraQuick® platform; sample self-collection and stabilization products for molecular applications; and oral fluid laboratory tests for detecting various drugs of abuse.
Overview Here at the OraSure family of companies our innovative sampling tools, services and diagnostics unlock access to accurate, essential information that advances global health and well-being. Our products include molecular sampling kits for the genome and microbiome, cutting-edge services and analytics, rapid diagnostics for infectious disease, and tests for substance abuse.
The Senior Director of Engineering and Facilities oversees the Engineering and Facilities teams across our multiple Bethlehem, PA locations, leading a team of 7 direct and 40 indirect reports. This role requires the successful applicant to be regularly onsite.
Snapshot of Responsibilities
- Oversee and lead the engineering and facilities personnel
- Maintain current production equipment for manufacturing at OTI and Contract Manufacturing facilities and direct the design of equipment to meet future production needs.
- Directs department activities to maintain OTI Facilities (100,000 sf+). Responsible for, maintenance, and the design, installation and maintenance of facility systems to support manufacturing operations (HVAC, DI/RO water, electrical, compressed air, back-up power, etc). Coordinates work of contractors to maintain manufacturing facilities and systems.
- Directs OTI Process Improvement activities, including process improvements for quality, cost or customer satisfaction. Directs failure investigations, customer complaint investigations, and qualification of materials and suppliers.
- Directs OTI Validation activities including process, equipment, software, cleaning, environmental and other required validations.
- Directs the technology transfer of new products from R&D to include selection and validation of production equipment/fixtures/tools, generation of batch records, development of test methods, and completion of all Engineering design control documentation.
- Resolves problems using solutions that involve new techniques, technologies, or concepts
- Analyzes technology trends, human resource needs, and market demand to plan projects
- Confers with management, production, Quality, and marketing staff to determine engineering feasibility, costs and implementation timelines for new and existing products.
- Performs job duties and tasks in compliance with OraSure Technologies’ Quality Assurance standards and requirements
- Ensures job duties and tasks conform to FDA and ISO regulations that apply to OraSure Technologies, Inc.
- Forecasts operating costs of department, compiles annual Operations Capital Budget and directs preparation of capital and expense requests.
- Advises management of new developments which may affect profit, schedule, costs, customer relations, and/or inter-departmental relations
- Provides direction and example for interpretation and application of company policies and procedures to the engineering activities
- Maintains a working knowledge of new technologies which may improve operations, and develops recommendations accordingly
- Maintains a working knowledge of safety policies and regulations to ensure duties of self and others are performed in a safe manner.
What You Bring
- Bachelor's degree in Engineering, Sciences or related field
- 9+ years of relevant and progressive experience leading engineering and facilities teams in ISO 13485 certified manufacturing environments
- Experience leading teams of direct and indirect reports
- Robust business and financial acumen coupled with experience in a matrixed or complex manufacturing environment
- Well-developed knowledge of Microsoft Office (Outlook, Word, Excel, PowerPoint). Familiarity with SharePoint, OneDrive, and Teams.
- Thorough knowledge of FDA’s Quality System Regulations (QSR).
- Knowledge and experience in enzyme immunoassays, molecular diagnostic collection devices or other medical device required.
- Exceptional oral and written communication skills and mathematics skills are required.
- Prior experience in project management
- Exceptional organizational skills and ability to manage multiple priorities required.
- Knowledge of statistics required, experience with sampling and SPC, and CAD software desired.
Culture, People & Community
The OraSure family of companies recognizes that the long-term health of our business is directly connected to the health of the planet, local communities and the OraSure family of companies employees.
- LIVE IT Committee – committed to creating an environment that embodies our values - All Means U: Employee Committee on Belonging hosts various events across all company locations such as monthly book club and mentorship program - Wellness Committee empowers colleagues to make critical decisions to improve and protect health - Sustainability Committee aims to minimize impact on the environment - Social Committee who organize and run events for both remote and onsite employees, to create connection and community
At the OraSure family of companies, we have a clear vision; cultivate an environment of equal employment opportunity where we do not tolerate discrimination or allow the harassment of employees or applicants on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by law with regard to any employment practices.
The OraSure family of companies aims to create and foster workplaces that reflects and contributes to the global communities in which we do business and the customers and partners we serve. This includes all communities impacted by our corporate presence. As part of this commitment, the OraSure family of companies and its subsidiaries will ensure employees and applicants are provided reasonable accommodation per request. If you require disability-related accommodation during the recruitment process, please contact Rebecca Zeleney at [email protected]. The OraSure family of companies will consult with all applicants who request disability-related accommodation during the recruitment process to ensure that the accommodation provided takes into account the applicant's individual accessibility needs.
