Manufacturing Technician - II

TekWissen ®; Oceanside (CA); In loco; USD 34.000 - 41.000; Part-time

Descrizione del lavoro

TekWissen is seeking a Manufacturing Technician II to support viral vector production in Oceanside, CA. This 12-month onsite assignment requires rigorous adherence to batch records, SOPs and cGMP, with teamwork across MSAT, Facilities and Quality to ensure safe, compliant operations.

The role involves handling raw materials, operating chromatography and ultrafiltration steps, and contributing to continuous process improvements in a fast-paced biotech environment.

Competenze

• Bachelor’s degree or equivalent biotech manufacturing experience.
• Experience in biotech/pharma manufacturing quality or engineering.
• GDP familiarity and cGMP awareness are desirable.

Mansioni

• Perform frontline manufacturing of viral vectors under supervision, following batch records, SOPs and cGMP.
• Collaborate with MSAT, Facilities & Engineering, and Quality to execute GMP runs.
• Weigh raw materials and perform MES/EBS transactions under supervision.
• Assist in revisions of SOPs, MPRs and review in-process cGMP documentation.

Conoscenze

cGMP knowledge

GMP runs

MES

EBS

Documentation practices

Data analysis

Communication skills

Teamwork

Formazione

Bachelor’s Degree

AA Degree with 2+ years experience

High School diploma with 3+ years experience

Strumenti

MES

EBS

GMP documentation systems

Descrizione del lavoro

Job Title: Manufacturing Technician - II

Location: Oceanside, CA, 92056

Duration: 12 Months

Job Type: Temporary Assignment

Work Type: Onsite

Pay Rate: $25.00-$30.00/HR

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.

Job Description:

Everyone at Client is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Would you like to join us in this mission?

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:

• 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

TekWissen® Group is an equal opportunity employer supporting workforce diversity.