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Validation Specialist


Validation Specialist

Validation Specialist

PACIV
Providence, RI

Job details

Job Type

Full-time

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).

Job Description:

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.


Requirements

  • 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.

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Other Requirements

Location: Rhode Island

Travel: Up to 10% of the time to various suppliers, collaborators, and client sites


Compensation

Competitive Salary and Benefits Package


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• Mobile: NA

• Location: NA

• Post ID: 21179161


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