Manufacturing Technician

Integrated Resources, Inc ( IRI ); Oceanside (CA); On-site; USD 52,000 - 76,000; Full time

Job summary

Integrated Resources, Inc (IRI) seeks a highly motivated Manufacturing Technician for a viral vector manufacturing facility in Oceanside, CA. You will support frontline manufacturing under minimal supervision, ensuring cGMP compliance and right-the-first-time performance.

Responsibilities include executing GMP runs with cross-functional teams, handling raw materials and MES/EBS transactions, and assisting in SOP/MPR revisions. Some off-shift and weekend work is required.

Qualifications

• Bachelor's degree in a science or engineering discipline.
• AA degree with 2+ years of experience in biotech/pharma manufacturing, quality or engineering.
• High School diploma with 3+ years of experience in biotech/pharma manufacturing, quality or engineering.

Responsibilities

• Execute manufacturing processes on the floor under supervision, following batch records, SOPs and cGMP regulations.
• Ensure right-the-first-time performance of process steps and support safety-first culture.
• Collaborate with MSAT, Facilities & Engineering, and Quality for GMP runs.
• Under supervision, weigh raw materials and record electronic inventory in MES and EBS.
• Perform chromatography and ultrafiltration/diafiltration for viral vector manufacturing in a cGMP environment.
• Prepare and use single-use systems for buffer prep and filter integrity testing.
• Assist with manual/ automated fill of harvested viral vector material.
• Escalate processing and equipment issues as needed.
• Assist revisions of SOPs and MPRs; review in-process cGMP docs for accuracy and compliance.
• Able to work off-shift hours and weekends.

Skills

Data analysis

Microsoft Word

Microsoft Excel

Education

Bachelor's degree

AA degree with 2+ years biotech/pharma experience

High School diploma with 3+ years biotech/pharma experience

Tools

MES

EBS

Job description

Shift: 5 days/week, Shift time could vary depending on business need.

The team rotates shifts, from Day to Swing to Grave, on a 1-2 month bases to monitor upstream/downstream process.

Job Description:

• We are seeking a highly motivated Manufacturing Technician to support our Viral Vector manufacturing facility in Oceanside, CA.
• Under minimal supervision, in this role you will be accountable for and focused on front line manufacturing of viral vectors.

Responsibilities (including, but are not limited to):

• Execute manufacturing processes on the floor under supervision, while rigorously following batch records, standard operating procedures (SOPs), and Current Good Manufacturing Practice (cGMP) regulations to ensure manufacturing operations are safe and compliant.
• Ensure right-the-first-time performance of all process steps specific to the step of operation, as well as help drive the safety-first culture at client Oceanside.
• Work as part of a team to execute Good Manufacturing Practice (GMP) runs in close collaboration with, Manufacturing Science and Technology (MSAT), Facilities and Engineering (F&E) and Quality departments.
• Under supervision, perform weighing of raw materials, as well as electronic inventory transactions utilizing Manufacturing Execution Systems (MES) and Enterprise Business system (EBS).
• Under supervision, perform Chromatography and Ultrafiltration/Diafiltration operations for the manufacturing of viral vector products in a cGMP environment using proper aseptic technique, proper cleanroom etiquette, Good Documentation Practices (GDP), and sound scientific methods.
• Prepare and use single use systems to support buffer preparation and filter integrity testing.
• Assist with manual and/or automated fill of harvested viral vector material.
• Escalate processing and equipment issues as needed.
• Assist with revisions of SOPs, Manufacturing Production Record (MPRs), and other controlled documents.
• Assist in the review of in-process cGMP documentation for completeness, accuracy, and compliance.
• Able to work off shift hours and weekend.

Basic Qualifications:

• Bachelor's Degree
• AA Degree with 2+ years of experience in manufacturing, quality or engineering in a biotech/pharma industry
• High School diploma with 3+ years of experience in manufacturing, quality or engineering in a biotech/pharma industry.

Preferred Qualifications:

• 0+ years of experience with Bachelor's degree in biology or related scientific discipline, or equivalent combination of experience and education.
• Prior experience with biopharmaceutical, cell or gene therapy manufacturing is a plus.
• Knowledge of the Current Good Manufacturing Practices (cGMP's) desired.
• Excellent skills in Microsoft Word, Excel and data analysis.
• Ability to lift 40 lbs repeatedly and stand for hours at time.
• Able to work off shift hours and weekend.