Software Quality Assurance Engineer

Responsibilities:

• Writing, reviewing and executing test plans (self-executed and automated) for a highly customizable hardware and software package.
• Performing documentation reviews.
• Assisting with Quality in all aspects of a small company.
• Possible travel to customer sites to assist in execution, as needed.

Required Experience:

• BS/BA Degree. Preferably a Scientific or Engineering degree.
• Minimum of 2-3 years experience in SQA work, preferably biotech or pharmaceutical.
• Knowledge of VB/C# .NET Framework is highly beneficial.
• Self-motivated and capable of adhering to strict deadlines is a must.
• Highly effective verbal and written skills, including technical writing, are a must.
• Proficient in Microsoft Office, particularly Microsoft Word 2007 and Excel.

Desired Experience:

• Familiarity with Continuous Integration processes & tools (e.g. CruiseControl.NET)
• Experience writing and following SOPs
• Experience with URS, FRS, and DDS documentation
• Working knowledge of 21CFR Part 11, audit trails, security features, cGMP, GDP and regulatory requirements for automated systems.
• Delta V experience and/or training or experience with another DCS platform
• Experience with HW/SW interactions.

Do you have the devious mind & fortitude to investigate/expose the nooks & crannies of a complex/ambitious software product, where developers fear to tread?

Validation Engineer

Position Type: Full-Time Employee
Location: San Jose, CA
Experience Level: 2-5 years
Education Level: BS/BA

Responsibilities:

• Assist with writing, reviewing and executing FATs, SATs and IOQs for a highly customizable software package. Completed under the direction of the Validation Manager.
• Interact with and train customers during FATs, SATs and IOQs.
• Perform documentation reviews of software FRSs and DDSs.
• Travel, both domestic and international, to customer sites to assist in execution.

Required Experience:

• BS/BA Degree. Preferably a Scientific or Engineering degree.
• Minimum of 2 years experience in validation work, preferably biotech or pharmaceutical.
• Validation experience: hands-on experience with the development and execution of FATs, SATs and IQ/OQs.
• Working knowledge of 21 CFR Part 11, GAMP, audit trails, security features, cGMP, GDP and regulatory requirements for automated systems.
• Self-motivated and capable of adhering to strict deadlines is a must.
• Highly effective verbal and written skills, including technical writing, are a must.
• Ability to adapt the validation model in a rapidly changing environment.
• Flexibility to multi-task and develop innovative solutions.

Desired Experience:

• Experience with Automated Process Control Systems (preferably DeltaV) is highly beneficial.
• Experience writing RTMs, Risk Assessments and Gap Analysis is highly favorable.
• Knowledge of GAMP 5 is a plus.
• Knowledge of VB or C#.NET Framework is a plus.
• Experience with HW/SW interactions is valuable.
• Familiarity with European validation practices is helpful.
• Experience with software PQs is a plus.

System/Software Developer (Emerson DeltaV)

We are seeking a motivated engineer that knows Emerson DeltaV from both a programming and fundamental operation viewpoint. Needs to be to design controls, database management, and communications protocols. Qualified candidates will perform a large subset of the following tasks:

• Design, implement, & test control strategies in DeltaV
• Design/develop OPC & MODBUS communications protocol programs
• The candidate will have the ability to execute research and development plans, and to evaluate the performance of new technologies.

Emerson DeltaV Software Developer Requirements

• B.S. or M.S. in computer science, electrical, chemical or control systems engineering, and a minimum of 5 years work experience
• Knowledge of VBA, VB6 or .NET Framework would be advantageous
• Understanding of batch control strategy and methodology would be advantageous
• Familiarity with OPC and MODBUS communications protocols
• Ability to self-manage and succeed at an individual level as well as work cooperatively in a team environment