Position: Validation Specialist Office Location: USA (Providence, RI)
PACIV, an international control systems integration and regulatory compliance engineering firm servicing Bio-Pharmaceutical, Medical Device, Food & Beverage, WTP/WWTP, and Utilities clients, is looking for a regular employment-based Validation Specialist at our USA office (New England office – Rhode Island).
The Validation Specialist will be responsible for the day-to-day support of validation activities for multiple projects/upgrades being conducted within our client’s Biotechnology site. This will be onsite support working within the client’s validation and automation department teams.
Position Responsibilities/Essential Functions
- Become familiar with the user, functional, and process requirements for assigned projects and tasks.
- Review proposed scope documents and perform assessments of validation impact on the site computer related systems and testing requirements.
- Review requirements and automation design specifications (FRS, SDS, URS, and RD).
- Develop software testing documentation per validation procedures and design and requirement specifications.
- Preparation and processing of testing documentation in EDMQ (electronic document management system).
- Provide support for execution of development testing, validation function tests and function test forms.
- Provide support for engineering change management process. Assist with coordination and execution of testing of automation errors. Generation, resolution, and closure of development software testing errors is also required.
- Execute Periodic Reviews on staggered schedule for various lab and in-process manufacturing equipment to ensure systems maintain in a validation and/or qualified state.
- Assist with coordination of automation activities between client teams and third-party vendors.
- Support resolution of automation issues (i.e. investigations) found during commissioning and validation.
- Bachelor’s degree in Engineering or Technical discipline required
- Minimum of six (6) months validation experience for Level I within technical/regulated industries
- Knowledge of industry CSV and C&Q expectations and requirements (e.g. FDA guidelines, USP, GAMP 5, ISO, etc.)
Desired Hard Skill Sets:
- Proficient in the development and execution of testing protocols for computerized control systems and any other CSV deliverables for system-development life cycle of industrial automated systems.
- Exposure to control systems validation within regulated FDA environment.
- Understanding of CSV system life cycle concepts and FDA regulatory requirements, including FDA cGMP’s for the 21st Century, 21 CFR Part 11 Guidance: Scope and Application, 21 CFR 211.68, ISPE Risk Based Approach, ISPE C&Q Guidelines 5, 12, ICH 9, ASTM E2500, GAMP5.
- Experience with development of URS, FRS’s, DDS, DQ, Traceability Matrix, and Final Reporting.
- Knowledge of Data Historian Systems (i.e. OSIPi).
Desired Soft Skills:
- Excellent analytical and problem-solving skills to be applied in troubleshooting of process control systems within Biotechnology site processes.
- Comfortable with 24/7 manufacturing environment, automation department
- Deals well with uncertainty and pressure.
- Works well with others, within a team and takes accountability.
- Result driven and self-motivated.
- Strong interpersonal and communication skills (verbal and presentation).
- Organized, with strong computer literacy such as MS Project, Excel, etc.
Location: Rhode Island
Travel: Up to 10% of the time to various suppliers, collaborators, and client sites
Competitive Salary and Benefits Package