Validation Engineer

Summary of Purpose/Function
We are seeking a highly motivated individual to assist with all aspects of validation in a company that markets to pharmaceutical and biotech companies. The job is a mid-level position working with our standard TruBio® software package.

The validation group is responsible for all aspects of validating our standard software platform including hotfixes, new releases, and customizations. We host FATs and work with the customer to execute our standard FAT as well as provide support throughout SAT and IOQ.

The optimal candidate will possess exceptional technical writing skills, GMP experience, and strong DeltaV knowledge. Experience with validation or coding VBA would be highly beneficial, and depending on experience level, may take the place of DeltaV experience.

We are looking for a highly self-motivated individual who works well as part of a team and is looking to expand his or her knowledge base working in a challenging environment.

Responsibilities:
• Assist with writing, reviewing and executing customer FATs, SATs and IOQs for a highly customizable software package. Completed under the direction of the Validation Manager
• Assist with writing validation tests for software customizations requested by customers. In general, this work is completed under an accelerated timeline
• Help develop and maintain SOPs
• Write validation summary reports
• Interact closely with customers for FATs
• Perform documentation reviews of software FRSs and DDSs.
• Some local or possibly international travel may be required, but will be minimal (<10%)

Required Experience:
• BS/BA Degree. Preferably a Scientific or Engineering degree
• Minimum of 5 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
• Strong 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
• Experience with DeltaV is required

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 VB or C#.NET Framework is a plus
• Experience with HW/SW interactions is valuable
• Familiarity with European, Asian (China, India, Korea, Japan), or South American (Brazil, Argentina) validation practices is helpful