Position Summary

The Systems Tester II works under the supervision of the R&D management team and performs tasks related to the testing of systems in development or on market. Responsible for planning, executing, and managing a variety of activities related to testing a combination of hardware, software and reagents including writing protocols, risk analysis, data review, documentation, and interpretation of results. Includes, but not limited to design requirements, validations, risk management, and experimental design. Receives general direction from department management; uses professional skill and judgement to work independently with functional teams within and outside Werfen, including hardware development, software development and reagent development. Testers are responsible for following good laboratory documentation practices in accordance with Standard Operating Procedures (SOPs) and other Quality System Requirements (QSRs).

Key Accountabilities

• Creates and executes validation protocols for less complex systems, or subsystems.
• Reviews and updates existing validation protocols.
• Completes and manages risk management files for less complex systems.
• Manages design requirements and inputs for less complex systems.
• Leads meetings to gather input for planning test protocol design, test tools, procedures, and system enhancements, or for improvements to existing processes.
• Leads the creation of experimental design for feasibility studies including defining acceptance criteria. Compiles and analyzes data; prepares scientific reports with recommendations.
• Collaborates with other functional groups to resolve questions, issues or complaints related to Werfen autoimmunity systems.
• Assists in creating new Design History Files (DHF) and maintaining existing DHFs for Autoimmunity Systems.
• Provides input for Traceability Matrix for assigned autoimmunity systems, including all subsystems.
• Provides input into operator and service manuals for assigned autoimmunity systems to the appropriate stakeholders.
• Develops and maintains successful professional relationships with diverse stakeholder groups, including colleagues, collaborators, and outside vendors.
• Adapts quickly and successfully to changes in operational priorities.
• Follows protocols for working safely with hazardous materials.
• Understands the safety, technical, recordkeeping and QSR aspects of position.
• Complies with applicable Werfen Autoimmunity SOPs, ISO, FDA and other QSR, as well as applicable Environmental Health & Safety, Human Resources, and all other regulatory and administrative policies.
• Reflects the values of Werfen and Inova in the quality of work and in working relationships.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Budget Managed

• Supports department budget indirectly by managing expenses effectively.

Networking/Key Relationships

• R&D teams: Assay Development & Biomarker Discovery
• Manufacturing & Operations teams
• Quality & Regulatory teams
• Field Service teams
• Software & Hardware teams

Minimum Job Requirements
Education

• Bachelor’s Degree in Science in Biology, Microbiology, Cellular Biology, Biochemistry, Computer Science, Software engineering, Computer science, Engineering (i.e., Electrical Engineering, Mechanical Engineering, etc.) or similar field of study is required.

Experience

• 4 or more years of experience in reagent, hardware, software or systems development, or an equivalent combination of education and experience required.
• 2 or more years of systems test design and execution experience required.
• Experience working within a regulated laboratory environment strongly preferred.

Skills & Knowledge

• Strong knowledge of immunology, including relevant laboratory techniques for diagnostics.
• Thorough understanding and experience in lab protocols, including standard laboratory equipment, and safety procedures.
• Strong knowledge and experience using Microsoft Word, Excel and PowerPoint.
• Demonstrated experience working in a fast paced, detail-oriented environment, requiring initiative, adaptability, and resilience.
• Proven track record of excellent communication skills, team focus and collaboration to achieve objectives.

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Travel Requirements

• Up to 10% travel required.

Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  While performing the duties of this job, the employee is regularly required to communicate. Must be able to detect, identify and inspect scientific data. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day.  Must be able to use hands to feel objects, including keyboard, telephone and pipettes or other lab equipment.  May need to reach with hands and arms, climb stairs, balance, stoop, kneel or crouch.  Will be required to talk and hear and have specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.  May occasionally have to lift and/or move up to 25 pounds.  The noise level in the work environment will vary but is usually moderate. 

Other Duties and Acknowledgement:

The above statements are intended to describe the general nature and level of work being performed by the incumbent. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of this position. Note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. This job description does not constitute or contain a contract or employment promise of any kind. Nothing contained herein modifies the at-will nature of employment with Werfen.

The salary range for this position is currently $72,000- $82,000 annual. Individual compensation is based on the candidate’s qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget and/or other business and organizational needs.