Barceloneta, PR, 00617, USA
9 days ago
Biologics Operator II (Downstream)
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Biologic Operator II manufacture of bulk biologics products. Perform cleaning and sterilization procedures. Perform process tests and participate in qualification and validation activities as required. Assemble and inspect equipment in the manufacturing area to confirm operational status. Work is performed in aseptic and non-aseptic environments. Responsibilities + Operate manufacturing equipment and instruments, such as tanks, autoclaves, filtration systems, washers, filter integrity testing, pH, amongst others. Conduct equipment setup (CIP, PT, SIP) operations according to the established procedures. + Manufacture of bulk biologics operations in Media & Buffer Formulation (Central Services), Inoculum or Fermentation (Upstream) and Capture or Purification (Downstream) areas according to approved and effective procedures. + Conduct equipment and facility inspections and advise of situations that affect operating and environmental conditions. Monitor critical parameters and elevate any deviation that could impact operations to address accordingly. + Provide technical assistance to manufacturing areas, specifically the troubleshooting support of equipment and process events. + Receive, inspect and verify materials availability to be used for the production activities. + Document, audit and timely correct manufacturing electronic or paper batch record discrepancies. + Document process and equipment status in electronic or manual records. + Sample collection and processing as required by the process. + Strict adherence to current Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP) and accurately complete process-associated documentation. + Provide assistance to operations in accordance with environmental management, occupational health and safety (EHS) systems and promote continuous improvement. Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal, and any other program applicable according to the position duties. Significant Work Activities + Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day). + Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day). + Work in a clean room environment Qualifications + Associate Degree in Science, Mechanics, Electricity, Instrumentation or related field. + No previous experience required. + Basic knowledge of laboratory techniques. + Basic knowledge of computerized systems such as Delta V, MES and SAP preferred. + Basic mechanical and mathematical skills. + Basic verbal and written communication skills in English and Spanish. + Availability to work Third shift, holidays, overtime including weekends, according to business needs. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​ ​ + The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​ + We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​ + This job is eligible to participate in our short-term incentive programs. ​ ​ Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​ ​ ​ ​ AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html
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