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Mindlance · 1 day ago

Biologic Operator

Branchburg, NJ

Contract

Onsite

Entry Level

$23/hr - $25/hr

1+ years exp

Mindlance is a company seeking a Biologic Operator to join their team in Branchburg, NJ. The role involves working in aseptic environments to produce sensitive biological products, including tasks such as equipment cleaning, solution formulation, and inspection of filled products.

Human Resources

H1B Sponsor Likely

Hiring Manager

Gursha Sharma

Responsibilities

Candidate will work on aseptic high level, silent environments and perform a repetitive task as syringes Inspection

Must be able to tolerate sitting in the same position for 6.5 hours a day (55 minutes consecutive and 5 minutes of visual rest) all day with low light and be able to tolerate 15 thru 25 degrees cold rooms and sporadically subject to coldest rooms of 2 thru 8 degrees

Biologics Operator I is responsible for the production of highly expensive and sensitive Biological Parenteral product, and is trained to carry out its tasks in different areas of the process, such as cleaning and preparing equipment, formulating solutions, process testing, filtering and transfer of solutions, and will also be trained to provide support in the aseptic filling of small volume syringes with the use of RABS (Restricted Access Barrier System) and inspection of the filled product in its final package

Make inventory of materials and parts necessary for manufacturing, perform process tests as required It will monitor alarm systems

Assemble equipment and perform cleaning and sterilization procedures

Comply with Good Manufacturing Practices (GPS) and with standard procedures (SOP's)

Inform the supervisor about any event that occurred during the work shift

Subject to additional responsibilities

The incumbent is responsible for complying with the company's policies with the procedures of the ABL plant and with the regulations and requirements of Good Manufacturing Practices (GMP) of the Federal Food and Drug Administration (FDA) Work on the cleaning, preparation and sterilization of manufacturing equipment

Work aseptically in the formulation of biological parenteral product

Perform process samples such as pH, density, and osmolality

Inspect the equipment to verify that they are operating within the established parameters

Carry out cleaning operations, pressure testing, sterilization of equipment, integrity of filters and RABS gloves, filtration of solutions, aseptic filling, product inspection

Monitor processes through computerized systems and visual inspection of equipment and recognize when process parameters are diverted to alert and take action to avoid process deviations and / or product loss

Receive and verify materials for the manufacture of the final product

Participate and assist in the qualification and validation activities of the SVP area

Keep a detailed record of the operations carried out during the work shift, batch records, logbooks and perform the required inventory transactions, either manually or electronically

Handle and dispose hazardous and non-hazardous materials according to established procedures

Attend and complete the internally trained training on industrial hygiene, occupational safety, and good manufacturing practices (GMP, SARA, CHAP, BOP and others)

Use the required personal protective equipment (PPE) and notify the supervisor of incidents or unsafe conditions in the work area

Responsible for operating efficiently in order to obtain the best product performance

Carry out production documentation in a legible manner, without errors and on time, following good documentation practices and good manufacturing practices

Audit the batch records and logbooks of production as required

Maintain clean facilities following procedures, so aseptic conditions are maintained

Diagnose and resolve events or exceptions of highly complex equipment and processes through the interface of systems such as (HMI) Human Machine Interface (PLC) Process Logics Controls

Have an understanding and basic knowledge of equipment and processes with automated systems

Attend other areas within SVP as required or necessary

Provide assistance to operations in the control, management and disposal of domestic, biomedical and hazardous waste from their respective area as applicable, ensuring compliance with Federal local regulations following the procedures and policies of the plant

Qualification

Biology degreeAseptic techniquesManufacturing PracticesEquipment operationProcess testingInventory managementSafety proceduresDocumentation practices

Required

Must have a biology degree

1-2 years of working experience

Must be able to tolerate sitting in the same position for 6.5 hours a day (55 minutes consecutive and 5 minutes of visual rest) all day with low light

Be able to tolerate 15 thru 25 degrees cold rooms and sporadically subject to coldest rooms of 2 thru 8 degrees

Responsible for the production of highly expensive and sensitive Biological Parenteral product

Trained to carry out tasks in different areas of the process, such as cleaning and preparing equipment, formulating solutions, process testing, filtering and transfer of solutions

Trained to provide support in the aseptic filling of small volume syringes with the use of RABS (Restricted Access Barrier System) and inspection of the filled product in its final package

Operating different equipment such as parts washers, autoclaves, CIP (Cleaning in Place) systems, SIP systems (Sterilization in Place), formulation tanks, filter integrity testing machine, magnetic stirrers

Make inventory of materials and parts necessary for manufacturing

Perform process tests as required

Monitor alarm systems

Assemble equipment and perform cleaning and sterilization procedures

Comply with Good Manufacturing Practices (GPS) and with standard procedures (SOP's)

Inform the supervisor about any event that occurred during the work shift

Responsible for complying with the company's policies with the procedures of the ABL plant and with the regulations and requirements of Good Manufacturing Practices (GMP) of the Federal Food and Drug Administration (FDA)

Work on the cleaning, preparation and sterilization of manufacturing equipment