Validation Engineer (Biotech/Pharma)
Location – Raleigh, NC area
ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Head-quartered 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 and 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
The role entails the following primary job functions:
- Qualification and validation of bioprocessing equipment and support equipment.
- Accountable for writing and/or reviewing validation and equipment documentation (risk assessments URS, FAT/SAT, IOQ, SOPs, etc.), ensuring compliance with client and regulatory policies.
- Creation and review of high-level documentation such as VMPs, risk assessments, System Level Impact Assessments, criticality assessments, quality plans, commissioning plans, etc.
- Maintains knowledge of current good manufacturing practices cGMPs.
- Experience with good documentation practices (GDP)
- Contributes to high-performance/cross-functional teams created to support process improvement, scale-up, technology transfer, engineering and validation activities.
- Follows site specific work instructions, policies and procedures.
- Functions as a technical expert on process equipment or systems.
- Support troubleshooting for complex issues in manufacturing, and throughout project scope as required.
- Works on multiple projects or tasks of moderate scope and complexity as a team member, requiring minimal supervision.
Qualifications
- Requires a bachelor’s or master’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology or equivalent educational background.
- Must have 3+ years of experience in biotech-pharmaceutical environment.
- Knowledge of upstream/downstream drug substance manufacturing.
- Demonstrated experience with manufacturing processes and bioprocessing equipment, including both repeat-use and single-use technologies.
- Experience in Commissioning, Qualification and Validation (CQV) and lifecycle management
- Experience with startup, shakedown, and troubleshooting of equipment.
- Knowledge of regulatory compliance inclusive of cGMP, FDA regulations.
- Familiar with GAMP 5 methodology.
- Familiar with quality system such as deviation, change control, CAPAs, etc.
- Familiar with Data Integrity and 21 CFR Part 11
- Basic technical writing with proficiency in Excel, PowerPoint, Visio, Word, Sharepoint, etc. in addition to experience working within shared work environments.
- Strong interpersonal, written, and oral communication skills.
- Able to travel for business needs, if required.
- Willing to be at site full time, when required.
