About this opportunity
Integrated Resources, Inc ( IRI ) lists this Manufacturing Associate opportunity in oceanside, California. Review the employer’s description below for duties, qualifications and application requirements.
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.
Ability to work effectively in an inclusive, cross-functional, team-based environment.
Able to work off shift hours and weekend.
Additional duties as assigned.
Basic Qualifications:
Bachelor’s Degree Or
AA Degree with 2+ years of experience in manufacturing, quality or engineering in a biotech/pharma industry Or
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
Self-motivated and willing to accept temporary responsibilities outside of initial job description
Excellent interpersonal, verbal and written communication skills
Willingness to think outside of the box as well as comfortable in a fast-paced and constantly evolving environment
Ability to lift 40 lbs repeatedly and stand for hours at time
Able to work off shift hours and weekend
Worksite address
oceanside, CA, 92058, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.