Process Validation Engineer - Medical Device

Synergy Bioscience is a startup company that provides medicinal product development support and laboratory testing services to our partners in the pharmaceutical and medical device industries. In addition, we provide quality compliance consulting services to our partners in the pharmaceutical, medical devices, and biotechnology industries.

Our Mission is to support our clients expedite their product commercialization efforts by providing world class services in timely manner without compromising their business confidentiality.

• Perform validation studies on manufacturing equipment, including equipment set up and qualification, manufacturing process validation, as well as cleaning validation, and ensuring systems remain in a qualified, operational state of compliance associated with cGMP manufacturing work environment.
• Develop and execute equipment validations utilizing IQ/OQ/PQs to ensure that the new equipment meets safety, performance, and quality requirements
• Write and execute Validation protocols such as Installation, Operation, Performance and Cleaning Qualification documents.
• Work closely with Engineering / Facilities, Equipment End Users, and Quality Assurance to investigate and resolve non-conformances encountered during qualification/validation activities.
• Assist in investigating deviations related to facilities, utilities, and equipment.
• Participates in multi-functional department teams for facilities, utilities, and equipment to meet established project timelines.
• Write new and revise current Standard Operating Procedures (SOPs).
• Identify gaps in existing program and devise approaches to improve them.
• Ability to work in a fast-paced, dynamic, and innovative environment.
• Work with limited supervision and take ownership of projects to meet scheduled timeline and technical goals.
• Maintain accurate and thorough records.

• BS in Engineering (chemical or mechanical) with 5+ years of validation work experience.
• Working knowledge of cGMP manufacturing, ISO and FDA guidelines on Quality Systems, specifically in the areas of process and equipment validation as well as regulatory requirements for medical devices.
• Understanding of commissioning / qualification / validation principles.
• Experience authoring and executing Validation protocols such as Installation, Operation, Performance and Cleaning Qualification documents.
• Excellent interpersonal and communication skills (verbal and written) are required.
• Ability to interact well with other groups and must be able to take ownership of and follow through on assignments.
• Experience with investigating deviations related to facilities, utilities, equipment, and systems.
• Reviews and updates the Master Validation Plan in accordance with Company standards.
• Experience writing SOPs.
• Ability to lead continuous quality system improvements for the validation program.

Location:

Dallas

Compensation:
Hourly that is based on experience. Negotionable.

Duration:
The duration of this project is at least one year, but there is a strong probability for extension.