Pilot Plant Associate - Chromatography, ultrafiltration at VTekis Consulting LLP

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

12 Mar, 26

Salary

0.0

Posted On

12 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Chromatography, Ultrafiltration, Depth Filtration, Good Manufacturing Practices, Good Documentation Practices, Collaboration, Manufacturing Investigations, Quality Systems, Enterprise Resource Planning, Technical Writing, Communication Skills, Process Improvements, Bioprocessing Equipment, Regulatory Compliance, Root Cause Analysis, Process Troubleshooting

Industry

Staffing and Recruiting

Description

Company Description VTekis Consulting LLC provides complete solutions for Staff Agumentation, Recruitment Process Outsourcing, Contract Hiring, Direct Hire and Outsourced Solutions. Our goal is to deliver quality professional services to our clients not just to find someone to do a job, we match the right professional for your staffing needs and earning confidence through the proper assignment of people. This alignment of people and companies allows us to create opportunity. Most importantly, We don’t consider the process complete until we find the perfect fit. Job Description Qualifications · B.S. degree in biology or related area with 4-6 years of experience working in process development or Manufacturing support in bioprocessing required · Hands on experience with Chromatography, ultrafiltration and depth filtration process acquired through lab, pilot or production scale experience. · Good manufacturing practices required · Good documentation practices required · Ability to effectively collaborate with team members · Experience with manufacturing investigations for biologics manufacturing. · Familiarity with Quality systems and Enterprise Resource Planning etc. Responsibilities (Essential Role Responsibilities): · Perform downstream purification processes, including chromatography, ultrafiltration, tangential flow filtration and depth filtration, at pilot and production scales. · Operate and maintain standard bioprocessing equipment such as chromatography systems, ultracentrifuges, and tangential flow filtration (TFF) units. · Adhere strictly to current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in all activities. · Prepare, review, and maintain batch records, SOPs, logbooks, raw material specifications, campaign summary reports, technology transfer documents, and presentations in compliance with regulatory requirements. · Collaborate with cross-functional teams to support manufacturing investigations, root cause analysis, and process troubleshooting. · Ensure compliance with company SOPs, training requirements, and scale-up best practices. · Maintain facility readiness and support regulatory inspections through vigilant oversight. · Utilize Quality Systems and ERP platforms to document and track manufacturing activities. · Drive process improvements through the change control process or other initiatives. · Apply professional expertise to routine assignments; may supervise or serve as lead during on-floor activities. · Provide process subject matter expertise and take ownership of assigned deliverables. · Preferred: Experience conducting manufacturing investigations in biologics production. · Demonstrate strong technical writing and communication skills. · Maintain a safe working environment and stay current with all assigned training. Position Requirements (Required and/or Preferred Skills, Experience and Education): Regards, Mohammed Ilyas, PH - 229-264-4024 or text - 229-469-1455 or you can share the updated resume at Mohammed@vtekis. com Additional Information All your information will be kept confidential according to EEO guidelines.

Responsibilities

The Pilot Plant Associate will perform downstream purification processes, including chromatography and ultrafiltration, at pilot and production scales. They will also operate and maintain bioprocessing equipment and ensure compliance with Good Manufacturing Practices.