CQV Engineer

Boston/Rhode Island

ADVENT Engineering Life Science Solutions, a Trinity Consulting Co., is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Located near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, ADVENT is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.

ADVENT's services include process engineering, automation engineering, project engineering, HVAC/facility system design, process development, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.

The successful candidate will work with a group of engineers involved in the design, automation, commissioning & qualification and start-up of various processes, systems, and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set. This is an outstanding opportunity to join our growing team!

Responsibilities:

• Draft and implement Quality System documentation designed to establish good validation practices within the organization.
• Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards.
• Design validation approaches, supported by appropriate statistical analyses, perform and/or coordinate all validation activities, analyze and assemble results, and draft validation reports.
• Provide input on user and/or functional requirements of current and future processing equipment, and draft appropriate documentation. Additionally, interface with Contract Manufacturers to ensure all relevant user and functional requirements are met.
• Provide support to non-engineering Staff, including those from R&D and Manufacturing, to ensure successful technology transfer and continuous improvement.
• Execute assigned duties on time and pro-actively telegraph delays and other issues to validation manager and other relevant stakeholders.
• Comply with all regulatory, corporate, and Quality System policies

Qualifications:

• B.S. / M.S. in engineering or another relevant discipline.
• Minimum of 4+ years of experience working within a medical device environment or other FDA regulated environments. Experience with device-biologic combination products is highly desirable.
• Experience in the areas of Design Documentation (URS, FRS, DS, and other engineering specifications), Validation (IQ, OQ, PQ, PV, CSV, MVP, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc)
• Experience with Process Engineering or Process Validation
• Working knowledge of Computer Systems Validation lifecycle and documentation.
• Proficient in Microsoft Word, Excel, PowerPoint.
• Must be able to work independently with adequate supervision, multi-task, and support several projects simultaneously.
• Must demonstrate strong communication, interpersonal and teamwork skills.
• A strong understanding of technical writing and presentation skills is required.