Validation Scientist
Company: Randstad USA
Location: Fort Worth
Posted on: June 24, 2022
Job Description:
Validation ScientistDirect-Hire (Perm Role)Location: Fort Worth,
Texas (On-Site)Shift: 1st shift, Mon thru Fri, 8am to 5pm
SUMMARY / OBJECTIVE:A Validations Scientist (VSc.) is responsible
for the commissioning, qualification, and validation (CQV)
activities at Sovereign Pharmaceuticals. The role requires a basic
understanding and work experience with the validation requirements
associated with a pharmaceutical manufacturing facility.
ESSENTIAL FUNCTIONS:
- A VSc. is knowledgeable and experienced for site compliance
related functions for validation activities (e.g., Process
Validation, IQ OQ PQ Validation, Computer System Validation (CSV),
and Method Validation).
- Coordinates and leads validation project execution for
equipment, critical utilities, automated systems, software,
cleaning validation, and process validation.
- Works within the documented Risk Management System for
Validations.
- Authors with guidance and executes validation protocols.
- Ensures protocols, records, and procedures are compliant with
current Good Manufacturing Practices (cGMP), Good Automated
Manufacturing Practice (GAMP), and Sovereign's SOPs.
- Writes specifications (design requirements, functional
requirements, and user requirements), trace matrices, validation
summary reports, and test protocols for installation, operation,
and performance under the guidance of the department
management.
- Writes, and revises SOPs.
- Good working knowledge of regulations and guidance's (e.g., 21
CFR part 11, 21 CFR part 210, 21 CFR part 211, ICH, ISPE, PDA,
MHRA, PICs).
- Has a good understanding of the concepts of data integrity and
statistical treatment of experimental data. Can, with supervision,
review and recognize laboratory data that is compliant to
applicable regulations and meets study protocol acceptance
criteria.
- Writes Technical Reports that summarize the execution of the
protocols which express conclusions that are congruent with the
experimental results.
REQUIRED EDUCATION AND EXPERIENCE:
- Bachelor's Degree in a physical or an applied scientific
discipline (e.g., Chemistry, Engineering) with three years of
experience is required in areas of validation, qualification, and
commissioning in the pharmaceutical industry.
- Demonstrated experience with authoring and execution of
documentation including validation documentation, technical
protocols, and technical reports.
- Demonstrated ability for supervised work that requires
multi-tasking and a high level of attention to detail.
- Demonstrated ability to be an active participant on teams.
- A working knowledge of project management skills and techniques
to ensure one's own projects are executed on time.
- Knowledge of FDA Current Good Manufacturing Practices (cGMP)
and Good Automated Manufacturing Practices (GAMP)
requirements.
- Demonstrated experience with responses for FDA, EMA, or other
regulatory agencies requests.
- Demonstrated proficiency in computer skills as a business tool,
specific work experience using Microsoft applications (Word, Excel,
PowerPoint).
PREFERRED EDUCATION AND EXPERIENCE:
- Bachelor of Science Degree in Chemistry with three years of
experience in areas of validation, qualification, and commissioning
in the pharmaceutical industry.
- Demonstrated experience with the execution of Design of
Experiments protocols to determine critical parameters for
processes.
- Has basic knowledge of the key scientific, technical, and
regulatory challenges associated with the manufacture of
non-sterile pharmaceutical solid and liquid oral-dosage-forms.
Keywords: Randstad USA, Fort Worth , Validation Scientist, Other , Fort Worth, Texas
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