Parenteral Support Operator I

Select Source International; Puerto Rico; On-site; USD 25,000 - 34,000; Full time

Job summary

Select Source International is seeking an entry-level Parenteral Support Operator I to operate equipment in aseptic or non-aseptic environments, inspect syringes, assemble and inspect equipment, and perform cleaning and sterilization procedures. The role involves documenting batch records and maintaining compliance with cGMPs and SOPs, with shifts including weekends and overtime as needed.

Qualified candidates hold an Associate Degree in science or related fields and have basic lab knowledge

Qualifications

• Associate Degree in Science, Mechanics, Electricity, Instrumentation or related field.
• Basic knowledge of laboratory techniques.
• Basic knowledge of computerized systems such as Delta V, MES and SAP preferred.
• Basic mechanical and mathematical skills.
• Basic verbal and written communication skills in English and Spanish.

Responsibilities

• Inspect and pack syringes of biologic parenteral product.
• Clean, prepare and sterilize manufacturing equipment for parenteral use.
• Conduct equipment and facility inspections and raise issues affecting operations, safety or environment.
• Receive, inspect and verify materials for production; sample collection as required.
• Document, audit, and correct batch record discrepancies.
• Perform cleaning operations according to procedures.
• Document process and equipment status in electronic or manual records.
• Monitor critical parameters and address deviations.
• Comply with cGMPs, SOPs and documentation requirements.
• Assist operations with EHS compliance and continuous improvement.

Skills

Basic laboratory techniques

Delta V

MES

SAP

Basic mechanical skills

Basic mathematical skills

English and Spanish communication

Education

Associate Degree in Science or related field

Tools

Delta V

MES

SAP

Job description

Job Description

Parenteral Support Operator I

Employment type

HOURLY

Location

Description:

Purpose:
Operate different equipment in one of the functional areas assigned. Perform inspection and pack syringes. Assemble and inspect equipment in the manufacturing area to confirm operational status. Perform cleaning and sterilization procedures. Work is performed in aseptic or non-aseptic environments.

Responsibilities:

• Inspect and pack syringes of biologic parenteral product.
• Clean, prepare and sterilize manufacturing equipment for parenteral use.
• Conduct equipment and facility inspections and raise situations that affect the operating, safety, and environmental conditions.
• Receive, inspect and verify materials availability to be used for production. Sample collection and processing as required by the process.
• Document, audit documentation and timely correct manufacturing electronic or paper batch record discrepancies.
• Perform cleaning operations according to the established procedures.
• Document process and equipment status in the area electronic or manual records.
• Monitor critical parameters and raise any deviation that could impact the operations to address accordingly.
• Strict adherence to current Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP) and accurately complete process-associated documentation.
• Provide assistance to operations in accordance with environmental management, occupational health and safety (EHS) systems and promote continuous improvement. Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal, and any other program applicable according to the position duties.

Qualifications:

• Associate Degree in Science, Mechanics, Electricity, Instrumentation or related field.
• No previous experience required
• Basic knowledge of laboratory techniques.
• Basic knowledge of computerized systems such as Delta V, MES and SAP preferred.
• Basic mechanical and mathematical skills.
• Basic verbal and written communication skills in English and Spanish.

Candidates must be available to work any shift and OT/DT based in business needs.

Shift: Rotative/Hard Shift/Weekend

The requirements for a Parenteral Support Operator I, Parenteral Operator, Biologics Support Operator I is an Associate Degree in science / related fields and no experience is required. The associate degree in science is important for customer operation due to the type of product they manufacture.

What are the top 3-5 skills, experience or education required for this position:

• Associate Degree in Science, Mechanics, Electricity, Instrumentation or related field.
• Basic knowledge of laboratory techniques.
• Basic knowledge of computerized systems such as Delta V, MES and SAP preferred.
• Basic mechanical and mathematical skills.
• Basic verbal and written communication skills in English and Spanish.

Experience Level = 1-3 Years

Enable Skills-Based Hiring No Provide the days of the week and the hours that this position will require: