Manufacturing Technician

Job Title: Bioprocess Manufacturing Technician

Location: Oceanside, CA

Duration: 24 Months

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Job Description:

As a Bioprocess Manufacturing Technician, you will be responsible for producing medicine in a highly automated and controlled environment. Each product has a specific recipe; you will follow this recipe, along with the standard operating procedures, to operate the production equipment across various areas, including raw material dispensing/aliquoting, cell culture and purification. You will maintain records and follow all the steps necessary to comply with regulatory requirements within a current Good Manufacturing Practices (cGMP) environment.

The Opportunity

As a Manufacturing Technician, you will work within a team to produce and deliver quality products for patients around the world. We are a 24/7 site and the work load is divided across multiple organizations. Technicians are expected to work in a safe manner and follow our Standard Operating Procedures at all times. Doing these two critical aspects of our job helps us maintain our right to operate and commitment to governing bodies around the world.

Our Manufacturing process begins in Upstream, where we thaw and scale up our process. Some of the responsibilities for Upstream technicians are: preparing the medium needed for cell growth and maintaining our Cell Cultures which includes the set-up and breakdown of stainless steel bioreactors.

In Downstream, technicians work on a series of operations to isolate, purify, and concentrate the product. This includes preparation of Buffers, cleaning and steaming in place Chromatography skids, and supporting formulation.

This posting is for the Production Services Area within our Manufacturing organization

Technicians in this department perform the weighing and aliquoting of raw materials into intermediate bulk containers for use in our stainless steel facility. The team also supports single-use operations by kitting materials and preparing small-scale solutions. Additional responsibilities include washing, autoclaving, and preparing small equipment parts and assemblies, as well as conducting environmental monitoring throughout the facility.

Who you are:

You are someone who wants to influence your own development and can work independently, with limited supervision. You are looking for a company where you have the opportunity to pursue your own interests; where a job title is not considered the final definition of who you are, but the starting point. Experience with biologics manufacturing is not necessary but preferred.

Candidates must be able to work any of the following manufacturing shifts:

• 10 hr Day Shift, 6:00 am – 4:30 pm

• Sunday - Wednesday or

• Wednesday - Saturday

• 10 hr Swing Shift, 12:30 pm -11:00 pm

• Sunday - Wednesday or

• Wednesday - Saturday

Onboarding practices vary with area, but may consist of a multi-week schedule of Monday - Friday 8am - 5pm followed by on the job training for multiple weeks Monday - Thursday or Tuesday - Friday swing shift. Once onboarding and/or training is complete, you will be released to your assigned Manufacturing shift. Shift availability will be determined by matching candidates strengths to shift needs and are subject to change based on business needs and production schedules.

Shift availability will be determined by matching candidates strengths to shift demands and subject to change based on business needs.

Behaviors, competencies, and qualities of the ideal applicant:

Hardworking and fast learning individual that thrives in a high paced environment

Experience in clean room environment and familiarity with cGMP and ISO/FDA standards is strongly preferred

Ability to think critically and work both tactically and strategically

Strong quality mindset with attention to detail and a desire to deliver service excellence

Ability to work effectively with others, exhibiting a professional manner and establish constructive working relationships

Qualifications / Requirements:

Proficiency in the English language- reading, writing, and communication.

Must be able to work all shifts, required overtime as needed, and stand for extended periods of time.

Must be able to interface with computer systems to successfully operate manufacturing equipment. Experience with distributed control systems or other manufacturing automation is preferred.

Must be able to successfully pass all job-related tests and certifications required for working in a cGMP quality environment including but not limited to: inspections and GMP requirements to perform essential functions of the job.

Must re-qualify every year on all job-related training and certifications as job or qualifications require.

May climb upwards of 6 flights of stairs a day to maneuver within the manufacturing facility.

Lifting up to 25lb may be required.

The cleanroom environment requires that company provided gowning is worn. This may include plant uniform, coveralls, gloves and safety shoes. Additionally, regulations prohibit makeup, jewelry, and other personal items from entering the clean room environment.

Education / Experience / Attributes (By Level):

Scientific and technical degrees preferred, e.g. Life Science or Engineering

Experience in a GMP working environment with is highly desired with experience in the operation of complex mechanical equipment used in the washing, autoclaving, processing, and assembly of parts used in Upstream or Downstream processes

Target industries include pharmaceutical, biotechnology, biomedical, electronic, and chemical, food, cosmetics, and/or other medical industries.

Understands the theory, concepts, and regulations behind biopharma technology and processes.

Relocation benefits are not available for this posting.

Please note: We currently do not sponsor work visas for this position or offer relocation assistance. xhyhwjd

The expected salary range for this position based on the primary location of California is ***/hour. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.