Device Operator I

Posted 12 Mar 2019

Temecula, California - United States

Req Id 188693

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.


Your Role:

Manufacture and package products for Life Science business unit resulting in customer satisfaction. Compliance with applicable governmental and environmental health agency regulations and achievement of internal production objectives. Partner with Planning, Quality Assurance, Distribution, and Upstream Operations to assemble products in final configuration to meet customer needs.

All Production Associates are expected to possess and demonstrate the general knowledge and skills defined in the “Basic Skills and Abilities” section below. In addition, Level I Production Associates are expected to be highly proficient in at least one of the work areas outlined in the “Work Areas and Specific Tasks” section and are expected to develop additional skills beyond the basic skills and abilities through cross-training in some or all tasks in at least one other work area.

Basic Skills and Abilities

•Working knowledge of manufacturing ERP systems required; Oracle/SAP preferred

•Area clearance tasks and maintaining separation of product

•Ontime Manufacture of products as needed per Planning department

•Perform standard and new operating procedures

•Collect and record data on documents and batch records where required

•Utilize computer hardware and software for data entry and record keeping where required

•Ensure compliance with all Quality and Regulatory specifications

•Participate in production failure investigations

•Contribute to overall manufacturing performance metrics: Productivity, customer satisfaction and quality improvements

•Support process improvement through identification and reporting of areas needing improvement and assisting in improvement projects

•Basic math skills and knowledge of the metric system

•Demonstrated knowledge and proficiency with personal computer hardware and software in a business environment; Microsoft Office products preferred

•Working knowledge of Quality Management Systems (QMS) and other applicable data bases

•Familiarity with and proper use of safety equipment and Personal Protective Equipment (PPE): Safety glasses, hearing protection, protective clothing, use of automated devices and equipment designed to reduce repetitive stress, etc.

•Demonstrated attention to detail and ability to complete work according to daily schedule

•Demonstrated ability to learn and understand safe laboratory practices

•Support 6S programs to maintain lean work environment

•Ability to accommodate occasional overtime as needed to meet production requirements

•Ability to adapt to rapidly changing business circumstances and ability to thrive in a constantly changing business environment

•Comply with applicable established cGMP, FDA, OSHA, EPA, and Quality System regulations

•Additional duties as defined by management and business needs

•Follow ergonomic limits set by management per health and safety requirements.

Work Areas and Specific Tasks:

Fill

•Safely and correctly execute filling operations

•Perform procedures involving calculations and material measurements; collect and record data on batch records

•Safely operate standard production and fill equipment

•Correctly use of Biological Safety Cabinet (BSC) and Laminar Flow Work Stations

•Use automated equipment such as repeater pipette, liquid pump dispenser, auto-cappers and future production automation

•Execute Aseptic Technique

•Conduct support functions such as stocking and distributing supplies

•Fill various containers with products of various materials and sizes

•Use basic scientific laboratory equipment such as pipettes, scales, pH meters, fume hoods, and filters

•Properly handle and dispose of biologically hazardous materials and chemically hazardous materials

Pack/Assembly

•Use automated equipment, such as auto-labelers, auto-baggers and future production automation

•Conduct support functions such as stocking and distributing supplies

•Apply labels to product, assemble kits and package products

•Ensure quality is maintained by verifying information is correct and work is performed per procedures

•Report any inconsistencies or non-conformances discovered during procedures

•Responsible for verification and final product quality

Screening

•Utilize multiple databases to screen work orders and create a Discrete Job (DJ) packet

•Collaborate with outside departments such as Quality, Distribution, Planning, and other manufacturing labs to resolve any issues encountered in the screening process

•Prior to job start, identify and include all relevant document-specific instructions with DJ

•Ensure all paperwork is organized and attached to DJ to avoid errors downstream

•Compare Lower Level information with DJ Finished Good information and stop workflow if any inconsistencies or non-conformances are found

•Find appropriate information required for DJ and contact appropriate personnel if information is missing

•Ensure all items on Bills of Material for specific jobs are available for use by utilizing ERP system

•Work independently on routine work

 Completions

•Conduct ERP transactions correctly and accurately

•Ensure DJ paperwork matches ERP system before conducting transactions

•Return Finished Goods and Lower Level materials into correct storage temperature by following appropriate procedures

•Review DJ, Bills of Material and accompanying paperwork for accuracy and completeness

•Stop workflow if any inconsistencies or non-conformances are found

•Responsible for verification of final product

Label and Document Production

•Ensure print accuracy of lot-specific customer facing product labeling: Container label and product insert(s) as appropriate, utilizing one or multiple computer databases for information collection; engage in cross-functional interaction and confirmation of data, templates and/or printed labeling as required

•Execute accurate data recording, verification, and final product label quality for one or more complete operations following proper Good Documentation Practices (GDP) guidelines

•Complete all work in a timely manner. Comply with established work instructions and procedure documentation; complete activities in support of individual batch record and turn-around-time targets

•Ensure accurate and timely completion of assigned manufacturing records regarding materials and labor

•Verify accuracy and quality of sub-components for work orders issued to own work center operation

•Perform equipment calibrations/maintenance according to department guidelines and document according to established policies, procedures, and schedules for the department

•Perform or assist in validations/verification of processes and equipment

•Work independently on routine work and perform new types of work or special projects with minimal general instruction

•Participate in projects and continuous improvement initiatives including but not limited to QCAPA and Kaizen events

•Complete other duties as assigned by departmental management according to business needs

Who You Are:

Basic Qualifications:

  • Bachelor’s degree in a Life Science or commensurate education and 2+ years’ experience in a related discipline which supports performance of required tasks in a Final Production role
  • 1 year experience with automated equipment, such as auto-labelers, auto-baggers and future production automation

Preferred Qualifications:

  • Good verbal and written communication skills including the ability create clear, concise written reports and accurately complete batch records
  • 1+ year experience with data verification preferred
  • 1 +year experience with writing and/or editing Standard Operating Procedures preferred

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfill your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
 

Curious? Apply and find more information at come2emd.com

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.

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