Principal Manufacturing Technician

Davita Inc.; Oceanside (CA); On-site; USD 61,000 - 115,000; Full time

Job summary

A leading company in biotechnology is seeking a Principal Manufacturing Technician to join their team in Oceanside. This role involves operating equipment and following stringent quality standards to ensure the production of life-saving medicines. Candidates will benefit from competitive pay, potential bonuses, and a collaborative work environment focused on personal development.

Qualifications

• Experience in a clean room environment and familiarity with cGMP and ISO/FDA standards preferred.
• Proficiency in English required.
• Background in Cell Culture/Purification is highly desired.

Responsibilities

• Prepare medium for cell growth and operate bioreactors.
• Perform activities such as cleaning equipment and operation of chromatography processes.
• Follow safety procedures and comply with quality standards.

Skills

Problem Solving

Critical Thinking

Attention to Detail

Effective Communication

Team Collaboration

Education

Bachelor degree with 7 years experience

Associate degree with 8 years experience

High School with 12 years experience

Tools

Distributed Control Systems

Manufacturing Automation

Job description

The Position

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.

Genentech is the founder of the biotechnology industry and has been delivering on the promise of biotechnology for more than 43 years. It has been a member of the Roche Group since 2009 and is one of its most important centres of pharmaceutical research. At Roche, the patient is at the heart of all R&D efforts, and delivering life-changing therapies to patients while also driving positive change in the global society is the impetus to everything we do.

The Opportunity

• As a Principal 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 begins in Upstream Cell Culture, where we thaw and scale up our process. Some of the responsibilities include preparing the medium needed for cell growth, monitoring cell cultures, and assembly/disassembly of single use and/or stainless steel bioreactors.
• Subsequent to the cell culture phase is a series of operations to isolate, purify, and formulate the medicines. This includes activities such as preparation of buffers, cleaning and sterilization of equipment, operation of chromatography processes, and assembly and operation of single use equipment.

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:

12 hr Day Shift, 6:00 am - 7:00 pm,

- Sunday -Tuesday plus every other Wednesday

- Wednesday - Friday plus every other Saturday

10 hr Day Shift, 6:00 am - 4:30 pm

- Sunday - Wednesday

- Wednesday - Saturday

10 hr Swing Shift, 3:30 pm -2:00 am

- Sunday - Wednesday

- Wednesday - Saturday

12 hr Night Shift, 6:00 pm -7:00 am

- Sunday-Tuesday plus every other Saturday

- Wednesday - Friday plus every other 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 1:00pm - 11:30pm. 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.

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 25lbs 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:

• Bachelor degree with 7 years experience, or Associate degree with 8 years experience, or High School with 12 years experience

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

• Biotech certificate from approved program is considered a plus

• Experience in a GMP working environment with Background in Cell Culture/Purification 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.

Knowledge, Skills and Abilities

• Excellent oral and written communication skills demonstrated by communicating with other functions and management regarding resolving investigations and theory

• Capable of writing detailed reports and summaries

• Must possess a high level of automation and technical process knowledge as related to prep and process within area of responsibility

• Ability to lead department and/or cross functional meetings or projects

Relocation benefits are not available for this posting.

Pay transparency

The expected salary range for this position based on the primary location of Oceanside is 61,600 - 114,400 USD Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.