Manufacturing Operator

Manufacturing, Fill/ Label, CGMP, ERP, BioVue, Gel, ELISA, RhoGAM, EHS Guidlines, Pharma Experience
Contract W2, 1 year
Negotiable
Telecommuting not available Travel not required

Job Description

Please note this is a 1 year contract position.

 

POSITION SUMMARY:

This position is responsible for performing manufacturing procedures and executing diverse tasks in various manufacturing  areas related to Filling, Labeling and Line Tending  in areas such as BioVue, Gel, Donor Screening ELISA Plate processing, RhoGAM Filling, Label Control and Reprographics  according to detailed operational specifications and execution of scheduled tasks within a cGMP environment. Ensure materials are available to meet production schedule. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures and all applicable regulations. Accountable for adhering to all EHS guidelines.

 

*ESSENTIAL FUNCTIONS:

  • Execute manufacturing or manufacturing-support processes according to standard operating procedures and current curriculum.
  • Support schedule adjustments to meet production, material receipt and shipping requirements.
  • Work with Shift Leader//Team Leader to review departmental production schedules, work orders and related information to ensure materials are available for production.
  • Maintain  working knowledge of cGMP requirements to ensure adherence to compliance policies and regulations
  • Sets up and operates production equipment to produce work in process and finished goods
  • Perform  in-process testing as required by processes and procedures utilizing equipment such as: (Fillers, Labelers, Gel line, BioVUE line, ELISA plate equipment and pouchers, autoclave, oven,  torque testers, scales and printers) list is not all inclusive
  • Check products on line to confirm proper assembly and remove defective products
  • Take samples for further downstream testing and perform tests during processing according to standard procedures
  • Use of ERP system for performing material transactions/moves/quantities/cycle counts
  • Cleans , maintains, and performs basic repairs on equipment as needed
  • Operate and troubleshoot equipment in clean room and non-clean room environment
  • Assure manufacturing facility and equipment meets all requirements prior to production on all shifts.
  • Accurately complete documentation in batch records, logbooks, forms and other GMP documents.
  • Verify and enter production parameters per SOP and Batch Records.
  • Monitor environmental conditions inside and outside classified rooms
  • Wear the appropriate PPE when working in manufacturing and other working environments.
  • Demonstrate training progression, train designated personnel in all levels of responsibility
  • Review specifications and keep them up to current standards and practice and revise when necessary.
  • Understand Lean principles as it relates to work
  • Understand Value Stream maps and relevancy
  • Actively participates in Kaizen, problem solving and asset care
  • Proactively maintain a clean and safe work environment by performing sanitizing and housekeeping duties and looks for opportunities to improve. Take necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors

 

*ADDITIONAL RESPONSIBILITIES/DUTIES:

  • Offer suggestions and follow up on process improvements related to safety, compliance, cost, yield and productivity.
  • Carry out duties in compliance with all state and federal regulations and guidelines including FDA, TUV, EPA and OSHA.
  • Adhere to the safety code of Conduct & J&J EHS policies and attend all required EHS training.
  • Follow Global Leadership Profile (GLP) competencies based on their leadership level within the organization (individual leader)

 Support the ongoing production schedule by:

  • Report to work on-time and according to the shift schedule.
  • Perform other duties as assigned.
  • Attend departmental and other scheduled meetings.
  • Practice good interpersonal and communication skills.
  • Demonstrate positive team-oriented approach in the daily execution of procedures.
  • Promote and work within a team environment
  • Learn new skills, procedures and processes as assigned by management and continue to develop professionally.
  •  Assist with validation activities in the area
  • Responsible for audit preparation and participation
  • Recognize, open, write and review non-conformances

 

*This is not an exhaustive or comprehensive listing of job functions.  May perform other duties as assigned.

 

AUTONOMY and COMPLEXITY:

 

Operator 1

  • Needs direction to perform manufacturing daily tasks within functional area.
  • Performs and has basic understanding of processes and procedures.
  • Support and contributes to projects
  • Notifies Shift Leader or Supervisor  of maintenance and/or repairs needed on  manufacturing equipment or processes

 

 

Operator 2

  • Needs some direction to perform manufacturing daily tasks within functional area.
  • Performs and has good understanding of processes and procedures.
  • Assist with validation activities within the area.
  • Notifies Shift Leader or Supervisor  of maintenance and/or repairs needed on  manufacturing equipment or processes
  • May assist  in troubleshooting of routine manufacturing equipment/ processes

Operator 3

  • Independently performs manufacturing daily tasks and understands the inter-relationship of upstream and downstream activities
  • Perform validation activities within the area  in partnership with team members
  • Assists in representing the area for site wide projects as required.
  • Assists and may lead troubleshooting of routine manufacturing equipment and processes.

Operator 4

  • May act as Floor Coordinator in the area, prioritizes production requirements, understands the inter-relationship of upstream and downstream activities
  • Performs or may lead validation activities within the area in partnership with team members
  • May lead or represent the area for site wide projects as required.
  • Lead troubleshooting of routine manufacturing equipment and processes

 

      NATURE OF TASKS:

Operator 1

  • Basic mechanical and troubleshooting knowledge within functional  area
  • Demonstrate a basic understanding of the process in order to properly perform the assigned manufacturing tasks.

 

 

Operator 2

  • Good mechanical and troubleshooting knowledge within functional area
  • Demonstrate a good understanding of the process in order to properly perform the assigned manufacturing tasks
  • Identify discrepancies or trends that might need additional attention and notifies supervision

 

Operator 3

  • Strong mechanical and troubleshooting knowledge within area
  • Train other technicians on procedures.
  • Assist with schedule updates in coordination with team members and leadership.
  •  Demonstrate a strong understanding of the process in order to properly perform the assigned manufacturing tasks
  • Identify and assist in resolving discrepancies or trends that might need additional attention and follows up with supervision  

Operator 4

  • Superior mechanical and troubleshooting knowledge within area. 
  • Train and coach other technicians on procedures.
  •  Work with Shift Lead to schedule updates in coordination with team members and leadership.
  • Demonstrate a complete understanding for all processes and performs all assigned manufacturing tasks
  • Identify and resolve discrepancies or trends that need additional attention and follows up with supervision

 

 

 

 

 

 

 

    COMPUTER ABILITY:

Operator 1

  • Basic understanding and working knowledge of systems as required.
  • Ability to utilize tools within MS Office and other systems to improve business effectiveness.
  • Accurate Data Entry skills in ERP system

 

Operator 2

  • Good working knowledge and understanding of systems as required.
  • Utilizes tools within MS Office and other systems to improve business effectiveness.
  • Accurate Data Entry skills in ERP system

Operator 3

  • Strong working knowledge and understanding of systems as required
  •  Utilizes tools within MS Office and other systems to improve business effectiveness.
  • Accurate Data Entry skills in ERP system

Operator 4

  • Superior working knowledge and understanding of systems required.
  • Maximizes the use of tools within MS Office and other systems to improve business effectiveness.
  • Accurate Data Entry skills in ERP system

 

     EDUCATION AND EXPERIENCE:

Operator 1

  • 0-2 Years MD&D/Pharmaceutical experience or equivalent industry experience
  • HS Diploma or Equivalent required

 

Operator 2

  • Minimum of 2-4 Years MD&D/Pharmaceutical experience or equivalent industry experience
  • HS Diploma or Equivalent required.

 

Operator 3

  • Minimum of  4-6 Years MD&D/Pharmaceutical experience or equivalent industry experience
  • HS Diploma or Equivalent required.

 

Operator 4

  • Minimum of  6-8 Years MD&D/Pharmaceutical experience or equivalent industry experience
  • Associates Degree or Equivalent

 

LANGUAGE SKILLS:

  • Ability to read, write and speak English
  • Read and interpret documents such as safety rules, operating instructions and logbooks
  • Review and provide feedback for SOP and Batch Record Revisions
  • Good communication and written skills

 

 

REASONING ABILITY:

  • Follow a variety of instructions furnished in written, oral, diagram or schedule form.
  • Follow instructions, strong understanding of processes and interpretation of results
  • Solve practical problems and troubleshoot routine manufacturing equipment and processes 

 

MATHEMATICAL SKILLS:

  • Add, subtract, multiply and divide in all units of measure, using whole numbers, common factions, and decimals.

 

 

OTHER SKILLS, ABILITIES OR QUALIFICATIONS:

  • Understand Lean principles as it relates to work
  • Understand Value Stream maps and relevancy
  • Actively participates in Kaizen, problem solving and asset care

 

 

PHYSICAL DEMANDS:

While performing the duties of this job, the employee:

  • Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position.
  • Is frequently required to communicate with coworkers.
  • While performing the duties of this job, the employee is regularly required to stand; walk; use hands to finger, handle, or feel; climb, bend and stoop; and reach with hands and arms for extended periods of time.
  • Must pass vision acuity test for inspection of  work in process and finished goods
  • Ability to lift up to 40 lbs.
  • Needs to perform gowning procedures to work in manufacturing core or classified rooms.
  • Work with blood, blood products and chemicals
  • Work in a cGMP area and/or clean room environment
  • Overtime is required, as necessary
  • Shift work may be required, as necessary

 

Please reference job number 1540.

Posted By

San Francisco, CA

Contact
Dice Id : NETSO
Position Id : 1540
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