CSV Engineer
Location: Boston, MA
ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Headquartered near San Francisco, California, and with operations in the Eastern and Western US, Canada, and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design, process engineering, and quality system projects.
ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, 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, 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.
- Perform Data Integrity Assessments and review systems against 21 CFR Part 11.
- Provide input on user and/or functional requirements of current and future processing equipment, and draft appropriate documentation. Additionally, interface with 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 proactively communicate delays and other issues to the validation manager and other relevant stakeholders.
- Review DeltaV software and specifications to design test protocols.
- 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 an FDA regulated environment. Experience with upstream and downstream equipment is highly desirable.
- 2+ years’ experience utilizing DeltaV. Capable of interacting with software and designing protocols for DeltaV software customizations.
- 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).
- Strong 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.