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Night Shift RB Production Technician, Ops III

This position is a dedicated on-site night-shift position at the Berkeley, CA Bayer site. Support in the manufacture of Bayer rFactor VIII products (Kovaltry and Jivi) by performing daily cell culture and purification operations in accordance to cGMP and safety regulations to minimize any loss of sales

Night Shift - RB Production Technician, Ops III

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role are to:

• Cell Culture bioreactor system assembly and use, including control of gas supply to bioreactor, Micro-sparger assembly, Anti-Foam Emulsion system. Ability to troubleshoot and control processes.

• Continuous Cells Separation equipment preparation and process/ controls.

• Membrane Absorption Chromatography process (e.g. Membrane Absorption process, Buffer, and NaOH supply, cTCF supply, Capsule preparation, Inline dilution and Temperature control).

• Membrane Absorber technology, viral removal techniques and tangential flow filtration technology. Large scale chromatography, TFF technology.

• Prepares process equipment (including but not limited to bioreactors & ancillary equipment, Stainless Steel tanks, Pressure Transmitters, Flow Meters, Aggregate traps, Harvest discards, Transfer lines (buffers, cTCF), Hoses and small parts.

• Cleans and Sterilizes equipment using appropriate CIH (Clean-In-Place), SIP (Steam-In-Place) procedures.

• Performs daily or routine process operations in the cell culture and purification of biotech and biological products (Kovaltry, Kogenate, and Jivi). Operates equipment for these processes including:

• Inoculates and monitors bioreactors.

• Processes cTCF material to Continuous Cell Separation (CCS)

• Operates Chromatography, MAEF, MAVF and TFF skids.

• Membrane Absorber and filter clearance technology, and gradient controlled SP column separation techniques.

• Operates 50L, 200L, and 1000L collection bag technology to ensure robust collection, mixing and dilution of products.

• Performs PEGylation of JIVI in process material using TFF technology.

• Operates automated bagging systems.

• Blast Freezes products for storage.

• Dispenses chemicals and formulates solutions.

• Prepares acids and bases as necessary.

• Performs aseptic operations.

• Takes, analyzes and submits samples as required throughout the process.

• Monitors and controls operation with computer control systems.

• Completes all routine check sheets.

• Cleans equipment and maintains clean and orderly production facilities.

• Performs in-depth troubleshooting and root cause analysis of Kovaltry and Jivi equipment and process failures.

• Contributes to continuous improvement opportunities.

• Performs all operations in compliance with cGMP.

• Performs other related duties as assigned.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications :

• Completion of two-years' college science courses in (e.g. biology, chemistry, biochemistry, or microbiology) or a certificate from an accredited bio-technology academy.

• Relevant bio-tech industry experience in some or all of the following is preferred, and may be considered in lieu of some or all of the educational requirements above:

• Read, write, speak, and comprehend English in order to understand written and verbal instructions, SOP’s, BPR’s, etc.,

• Good verbal and written communication skills.

• Work weekends, nights, holidays and overtime as required.

• Acceptable attendance and performance.

• Able to work both independently/ self-directed with minimal supervision and in a team environment.

• Detail oriented with the ability to demonstrate good record keeping practices and ability to follow data integrity rules.

• Must have experience or computer literacy skills to learn new software applications, such as: Learning Management System (LMS), Document Control, Sentry DR/ CAPA System, Microsoft Office Suite and SAP.

• Familiarity with cGMP’s and applicable agency regulations.

• Basic knowledge of protein chemistry and purification systems such as anion, cation, and immunoaffinity chromatography.

• Must be able to cope with fast paced operations and repeatedly perform multi-step simultaneous operations with high degree of accuracy.

• Must be able to work under BC III (Class 100,000) gowning conditions.

• Must be able to lift up to ≤50 lbs. And push/pull up to 400 lbs. with assistance.

• Must be able to withstand frequent repetitive movement, stooping, crouching, kneeling, climbing (ladders), and sitting.

• Must be able to work in cold rooms.

• Must not have unusual sensitivity to typical lab chemicals or gloves (i.e. sanitizing agents), use required chemicals and wear protective clothing (PPE) and gowning as required.

• Must be able to differentiate color in order to monitor DCS computer and identify items using color-coded labels.

• Must meet Occupational Demands/ Physical Requirement checklist.

• Blood test for Hepatitis B and vaccine required.

This role includes shift work based on the following schedule:

Days : Wednesday - Sunday

Hours : 6pm - 6:30am PST

Employees can expect to be paid an hourly rate of approximately $39.76 with a night-shift differential of $2.75. Additional compensation may include a bonus or commission (if relevant).  Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc..  This salary (or salary range) is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.

This posting will be available for application until at least February 10th.

YOUR APPLICATION

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.

To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

Bayer is an E-Verify Employer.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Location: United States : California : Berkeley

Division: Pharmaceuticals

Reference Code: 837798

Contact Us

Email: hrop_usa@bayer.com

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