What are the responsibilities and job description for the Process Validation Engineering position at 3PL Vision LLC?
3pl Vision boasts over two decades of experience collaborating with leading global enterprises to meet their needs for flexible workforce solutions and on-demand talent. We are a worldwide organization offering strategic workforce management, IT consulting, and on-demand talent services. Our specialization lies in serving various sectors including Financial Services, Healthcare, IT, Life Sciences, Aerospace & Defence, Energy, Retail, Telecom, Manufacturing, and Engineering.
JOB DETAILS:
Job Title: Process Validation Engineering
Location: Saint Louis,MO
Duration: 6 Months
Guaranteed Hours: 40
Shift: 09:00:00 to 17:00:00
JOB DESCRIPTION:
Job Summary:
- The Validation Specialist will support validation activities related to facilities, equipment, computer systems, utilities, and cleanroom qualifications.
- This includes preparing and executing validation and commissioning protocols, as well as revalidation protocols.
- The role involves working with various teams to ensure compliance with industry regulations and ensuring the proper functioning of equipment and processes.
Key Responsibilities: * * Provide support for site facilities, utilities, and equipment qualifications.
- Prepare validation and commissioning protocols, along with protocol final reports.
- Execute approved protocols for equipment such as autoclaves, temperature chambers, vacuum ovens, etc.
- Prepare and execute revalidation protocols and protocol final reports for validated equipment.
Required Qualifications: * * Bachelor’s degree in Engineering or Life Sciences, or 4-5 years of equivalent practical experience.
- Competency in regulations including ISPE, PDA, USP, ICH, and US 21CFR Parts 11, 210, and 211.
Preferred Qualifications: * * Experience in technical writing, specifically preparing protocols and protocol final reports.
- Strong mechanical aptitude and critical thinking skills for troubleshooting and commissioning equipment/processes.
- Proficiency in Microsoft Office applications.
- Excellent written and verbal communication skills; ability to work effectively as part of a team.
- Ability to read, understand, and follow cGMPs, SOPs, specifications, and all relevant guidelines.
- Strong time management skills, with the ability to manage projects and meet testing timelines.
- Superior attention to detail. * Experience interacting with regulatory bodies.
- Knowledge of API products and Contract Manufacturing Organizations (CMO) is desirable, but not essential.
Job Type: Contract
Pay: $65.00 - $70.00 per hour
Expected hours: 40 per week
Schedule:
- Day shift
- Monday to Friday
Ability to Commute:
- Saint Louis, MO 63167 (Required)
Ability to Relocate:
- Saint Louis, MO 63167: Relocate before starting work (Required)
Work Location: In person
Salary : $65 - $70
