What are the responsibilities and job description for the Validation Scientist position at GCP Laboratories?
Job Summary:
The Validation Scientist is responsible for the technical ownership and successful execution of the Validation Program at GCP Laboratories. TS (Technical Services) Validation personnel provide stewardship of the site’s Validation Program, including assessment of and improvement in existing controls.
Duties/Responsibilities:
1. Establishes equipment qualifications by performing IQ (Installation Qualification, OQ (Operational Qualification), and PQ (Performance Qualification) on new and existing manufacturing equipment and processes.
2. Designs, authors, and executes protocols.
3. Develops and implements process validations.
4. Prepares cleaning validations.
5. Presents validation packages during regulatory/internal/customer audits.
6. Writes risk assessments.
7. Completes maintenance and continuous improvements of the Validation programs.
8. Writes validation protocols and reports in support of the site’s validation programs.
9. Plans and executes validation activities, including cross-functional coordination and internal coordination with Validation Specialists.
10. Prepares and provides technical review of completed/executed validation packages by compiling and analyzing validation data for submittal for review and approval.
11. Leads resolution of validation deviations through technical knowledge, execution of supporting validation studies, and manufacturing documentation review and approval.
12. Maintains an up-to-date knowledge of validation requirements, practices, and procedures
13. Writes and reviews policies and procedures (SOPs).
14. Performs risk assessments for validation programs.
15. Performs and/or coordinate validation studies, testing, verification, and sampling.
16. Represents/defends validation strategies during internal assessments / audits and external regulatory inspections.
Basic Requirements:
- B.S. in Science discipline preferably in a scientific discipline (Chemistry, Biology, Pharmacy, Engineering or a related field).
- Experience with a variety of pharmaceutical manufacturing equipment.
- 3 years of experience in Validation within the Pharmaceutical industry.
- Superior writing skills, strong accuracy, attention to detail, and technical knowledge.
- Knowledge of computer software, including relevant applications such as Microsoft Office.
- Knowledge of cGMPs regulations.
- Ability to handle multiple tasks concurrently and complete tasks in a timely manner.
Additional Preferences:
- Strong interpersonal and teamwork skills.
- Strong self-management and organizational skills.
- Oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization.
- Attention to detail, excellent review skills and analytical skills.
- Experience in Operations, TS, QA, QC, Regulatory, or Supply Chain within pharmaceutical manufacturing.
- Demonstrated understanding reviewing/writing technical documents, risk assessments/impact assessments, validation documents, IOQ protocols and final reports.
- Hands-on experience supporting/executing qualifications related to various processes and activities.
- Ability to drive change and motivate others toward a common vision including the ability to effectively influence others and lead others that are not direct reports.
Responsible for maintaining a safe work environment, working sa
Job Type: Full-time
Pay: $70,000.00 - $90,000.00 per year
Benefits:
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- Day shift
- Monday to Friday
Work Location: In person
Salary : $70,000 - $90,000