Operator - (Formulation Operator/Packaging Operator) - Mt. Vernon
Do you have expertise in, and passion for, manufacturing in a high performing pharmaceutical environment? Would you like to apply your expertise to impact the well-being of patients in a company that follows the science and turns ideas into life changing medicines? We have future Operator opportunities in Formulation and Packaging. See below for specific responsibilities and qualifications for each group.
At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe.
The Mt. Vernon site was established in 1972 and is the flagship site delivering innovative, life changing oral solid medicines. At the site we formulate and pack OSD tablets, capsules for over 60+ markets. The Mt Vernon site is the largest AZ production site in the US and is located in the southwest corner of the state of Indiana, approximately 15 miles from Evansville, Indiana - the third largest city in the state of Indiana. The Mt. Vernon site is dedicated to creating a culture of inclusion and collaboration. We host yearly Inclusion and Diversity conferences and have an employee resource group devoted to promoting diversity and inclusion and enhancing employees' professional development through interactive and engaging events and initiatives.
The Formulation Operator will operate a variety of Formulation equipment/processes to ensure production requirements are met or exceeded, following company policies/procedures to ensure product quality and compliance standards are met and performing all activities in a safe environment.
The Packaging Operator is responsible for producing packaged pharmaceutical products in a safe and efficient manner, following cGMP's, SOPs, and site safety procedures.
What you'll do:
- Must demonstrate ability to accurately operate equipment, perform equipment set-up/change-over/cleanups, assist in preventative maintenance and troubleshoot equipment problems to achieve optimum production levels
- Performs responsibilities ensuring compliance with Mt. Vernon Site standards, policies, and SOP's, for GMP and required documentation as well as performing job responsibilities in compliance with AstraZeneca Safety, Health & Environment standards and requirements.
- Works with Process Facilitators and other Operators/Mechanics/Technicians to identify and implement continuous improvement opportunities in equipment/production efficiencies and in the production area in general. Supports new equipment start-up and quickly learns and uses new systems, equipment and procedures. Supports the development/validation of new products/procedures. Offers ideas for standardization and simplification.
- Must be flexible in responding to changes to equipment/production assignments. Understands, interprets and advises on production schedules.
- Able to demonstrate good interpersonal skills and work in a robust team environment, with other operators, mechanics, technicians, supervision and project management with the goal of completing planned production and furthering Mt. Vernon Site and AstraZeneca initiatives.
- Able to work other shifts, weekends, alternative schedules when production demands require. Position will initially rotate shifts with the intent to move to a standard shift assignment.
Minimum Qualifications:(Formulation Operator)
- Operate packing equipment (tablet fillers, labelers, case packers, etc.) in a safe and efficient manner. Must understand and follow cGMP's, SOPs and site safety procedures. Verify correctness of product and components for the NDC packaged.
- Supply equipment with components and product. Lifting requirements may be up to 50 lbs. Perform detection system challenges on applicable equipment. Perform basic maintenance, changeover, set up, and troubleshooting of packaging equipment. Clean, purge, and inspect packaging equipment.
- Accountable for accurately documenting, packing, and cleaning activities in logbooks and electronic systems. Perform quality attribute inspections and in-process testing (torques, induction seal integrity, leak tests, appearance, etc.) Rework packages according to SOPs or Rework Packaging Order to correct deviations.
- Accountable for Line performance (OEE) and able to report hourly status of line to affected personnel to ensure timely resolution to issues. (i.e. Facilitators, Engineers). Must be able to work off shifts, weekends, alternative schedules, and rotate between shifts when production demands require.
- Must be flexible to change. Ability to perform duties with minimum supervision. Maintains a safe work environment and performs work in accordance with site, Safety, Health, and Environment (SHE) policies and procedures. Immediately report potential unsafe conditions to management.
- Supports internal, external, and regulatory inspections including FDA, EMEA, and third-party inspections. Participates in the investigation and resolution of product quality problems.
- High School Diploma or GED required
- Proven problem solving and troubleshooting skills.
- Basic mechanical proficiency.
- Basic computer skills; experience with Microsoft Office applications and SAP is desirable.
- Good interpersonal, communication and writing skills.
- Ability to perform duties with minimal direction.
- Knowledge of cGMP's.
- Ability to lift and/or move up to 50 pounds frequently
Preferred Qualifications:(Formulation Operator)
- High School Diploma / GED required
- Excellent verbal, written, and interpersonal communication skills.
- Basic mechanical proficiency.
- Basic computer skills.
- Three (3) years' experience as an operator in a production or regulated environment, pharmaceutical experience a plus.
- One (1) year experience in production environment, preferably pharmaceuticals.
- Experience in pharmaceutical production environment.
- Knowledge of cGMPs
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial -finding those moments and recognizing their potential. Interested? Come and join our journey!Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.Find out more on Social Media:
About Operations https://www.youtube.com/watch?v=gak5Ham8oUw
US based Employees: AstraZeneca has taken critical steps to protecting colleagues, loved ones, and patients from COVID-19 and its variants. COVID-19 vaccination is required for all US employees. Individuals who are unable to receive a COVID-19 vaccine based on applicable law, such as medical and religious reasons, can submit a request for a reasonable accommodation. For employees who are not vaccinated and who are granted an exemption to the vaccine requirement for qualifying reasons, the primary accommodation will remain weekly COVID-19 PCR testing.
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