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Associate/Technician, Pharmaceutical Manufacturing, Fremont Ca-Day Shift

Company

Boehringer Ingelheim
Address , Fremont, 94555, Ca
Employment type FULL_TIME
Salary
Expires 2023-06-24
Posted at 1 year ago
Job Description
This position is responsible for assisting the Sr. Associate and Master Associate in performing material handler duties, cleaning, visual inspection and filling responsibilities in designated manufacturing area.
Specific to the Sterile Filling area, this includes, but is not limited to:
  • Assists in the identification & correction of problems to prevent down-time
  • Movement of product, components and equipment within the aseptic processing area
  • Assists in the filling operation
  • Communication and hand-off to relief personnel during shift change as appropriate
  • Assists with minor equipment repairs/adjustments
  • Assists in the setup of filling room and Isolator
  • Assists with the cleaning of parts and equipment
  • Transfers product, components and equipment within the CNC, Class C and Class D processing areas.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities:
  • Assists the Sr. and Master Associate with real-time identification and correction of problems. Problems may include, but are not limited to mechanical issues, component issues.
  • Assists with Isolator and room cleaning in production areas. Will transfer rubbish to the transfer zones and may empty transfer zones of rubbish when required. This includes removal of equipment, room sanitization and disposal of waste according to established safety requirements.
  • Assists the Sr. Associate and / or Master Associate with Isolator and equipment set up. This assistance includes tasks such as gathering tools, machine parts, and documents required for such activities. Retrieves components and equipment from aseptic storage.
  • Responsible for following controlled documents to ensure that the equipment identified for operations are used and documented. This includes verification of equipment calibration. Completes log books, as required.
  • Responsible for performing filling operations and assisting in visual inspection operations.
  • Performs all work in accordance with Company Policies and Procedures. All work is documented in controlled documents (batch records, logbooks or SOP attachments) in accordance with SOP. All activities are to be documented in the batch record. All events are to be recorded in the batch record and brought to the attention of the production supervisor for further action.
  • Ensures components, materials and supplies are stocked prior to the start of the filling operations.
Requirements:
  • Demonstrated mathematical skills, including the ability to perform addition, subtraction, multiplication, division, and conversions.
  • Must maintain all training requirements and regularly checks the LOS training system in order to complete all required training on time.
  • Demonstrated written and verbal communication skills are required.
  • Must obtain & maintain qualifications, as required, to perform the assigned work.
  • Level of Proficiency - Entry level in subject matter
  • To remain in this position, employees:
  • Must be able to work in a team environment.
  • Bachelors’ degree, preferably in a science or engineering field.
  • Must be able to learn and perform basic computer operations such as MS Office and Outlook and other computer based software
  • Visual Demands - Position requires constant use of computer terminals and routine / repetitive work.
  • In lieu of a Bachelor's degree, will consider a minimum of three years closely related experience in a GMP or clean room assembly environment with an Associates Degree or six (6) years closely related experience in a GMP or clean room assembly environment with a High School Diploma or equivalent
  • Detail oriented. Demonstrated ability to read, comprehend, and follow written instructions.
  • Demonstrated ability to be organized and work well in small work groups.
  • Attendance / Schedule- The schedule is dependent on the shift for which the associate is hired. Attendance requirements are based on general attendance policies.
  • Physical Demands / Surroundings - Requires physical activity such as almost constant standing, walking, eyestrain, working with hands inside an Isolator, etc. Works regularly under desirable conditions with some moderately disagreeable conditions in the manufacturing setting.
  • Experiences in related GMP environment within biotechnology/pharmaceutical industry strongly preferred
  • Must be able to assist in trouble shooting activities and repairs to production equipment under the guidance of more experienced technicians.
  • Must adhere to proper technique, proper documentation practices, and all other aspects of the cGMP’s
  • Temperaments/Mental Requirements - The position requires concentration as errors might cause minor to moderate delays, confusion, or expense to correct. The position has some contact with other departments and the associate must be able to discuss issues and ideas with an open mind and even temper.
  • Must understand, will be held accountable for and must adhere to all SOPs, company Policies and Procedures

Technician Requirements:
  • Required to work according to given schedules in a 24/7 shift structure and flexibility to adapt working schedule upon prior given notice.
  • High school diploma
  • Preferable one (1) or more years of experience in cGMP regulated industry
  • Ability to work as part of a high performing team and collaborate effectively with staff.
  • Ability to concentrate on detail oriented work in a complex technical setup with a Quality and Right the first time mindset.
  • Strong written and verbal communication skills.
  • Ability to read and understand SOPs and work instructions and document work in a written format applying cGMP standards.
  • Ability to work with computer-based systems.
  • Working in a highly regulated environment following all applicable BI and BI Fremont SOPs, OCPs and BGSs for cGMP, EHS and Compliance policies.
  • Associates/Bachelor’s degree from an accredited institution or biotechnology vocational training preferred.

Eligibility Requirements:

Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older

Who We Are:

At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.
Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

Job - Manufacturing/Operations/ Production
Primary Location - Americas-US-CA-Fremont
Organization - US-BI Fremont
Schedule - Full-time