Biologic Support Operator I

Select Source International; Puerto Rico; On-site; USD 22,000 - 36,000; Full time

Job summary

Select Source International in the United States is seeking a Biologics Support Operator I to perform cleaning, sterilization, weighing, and material dispensing in aseptic and non-aseptic environments. The role requires basic lab technique knowledge and comfort with DeltaV, MES, and SAP, with bilingual English/Spanish communication.

Training will prepare you for shifts including third shift. The position is hourly, with overtime opportunities and a focus on cGMP compliance, safety procedures,

Qualifications

• Basic knowledge of laboratory techniques.
• Basic mechanical and mathematical skills.
• Basic verbal and written communicationskills in English and Spanish.

Responsibilities

• Perform cleaning, sterilization, weighing and dispensing of materials; monitor alarms and equipment; operate in aseptic/non-aseptic environments.
• Inspect manufacturing equipment to ensure parameters are met.
• Clean and sterilize equipment for manufacturing use.
• Monitor processes and report deviations.
• Collect samples and support process testing.
• Document batch records and equipment status in electronic/paper systems.
• Adhere to cGMPs and SOPs; complete process documentation accurately.
• Support EHS and continuous improvement programs; follow PPE and waste procedures.

Skills

Laboratory techniques

Mechanical skills

English/Spanish communication

Education

Associate Degree in Science/Mechanics/Electricity/Instrumentation

Tools

DeltaV

MES

SAP

Job description

Job Description

Biologic Support Operator I

Employment type

HOURLY

Description

Job Title

Biologics Support Operator I

Proposed Job Title

Biologics Support Operator I

Purpose

Describes the primary goals,objective or function or outputs of this position.

Key Responsibilities

• Perform cleaning, sterilization, weighing and dispensing of materials. Monitor alarm systems. Assemble and inspect equipment in the manufacturing area to confirm operational status. Work is performed in aseptic or non-aseptic environments. Perform process tests and participate in qualification and validation activities as required.
• Inspect manufacturing equipment to monitor that performance is within parameters.
• Clean and sterilize equipment for manufacturing use.
• Monitor manufacturing processes using electronic or manual systems and elevate any deviation that could impact the operations to address accordingly.
• Sample collection and processing as required by the process.
• Conduct equipment and facility inspections and advise of situations that affect operating and environmental conditions.
• Receive, inspect and verify materials availability to be used for production.
• Document, audit and timely correct manufacturing electronic or paper batch record discrepancies. Document process and equipment status in the area electronic or manual records.
• Audit documentation of operational activities and document discrepancies using computerized or manual systems.
• 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.

Additional Requirements

• Reason for Request Manufacturing volumes increase.
• Are you open to look at candidates willing to relocate at their own expense? NO.
• What are the top 3-5 skills, experience or education required for this position?
• What is a nice to have (but not required) skill, experience, education, or certification? N/a.
• In what type of environment would this individual be working (i.e.: Team; Individual; type of office, etc.) ? Teams.
• Daily Work Schedule Expectations ALL candidates must be available for any shift/weekend/holidays.
• Once training being completed will be assign to 3rd shift.
• Is overtime offered or required? Yes.
• Does this position offer the ability to work remotely on a regular basis or is it required to be onsite? NO.
• If remote opportunity exists what are the options (i.e., 1 day remote, 4 days on-site)? NO.
• Is Travel expected? If so, will it primarily be domestic or international? NO.
• Is the new hire going to be working with Toxins? NO.
• How many rounds of interviews? One round.
• Who will be involved in the interview process? Carol/MaryAnn/Velmarie/Claudio.
• Type of interview (video, phone or onsite)? Teams Interview.
• Experience Level = 1-3 Years.
• Enable Skills-Based Hiring No Provide the days of the week and the hours that this position will require:

1. Associate Degree in Science, Mechanics, Electricity, Instrumentation or related field. No previous experience required.

2.Basic knowledge of laboratory techniques.

3. Basic knowledge of computerized systems such as Delta V, MES and SAP preferred.

4. Basic mechanical and mathematical skills.

5. Basic verbal and written communicationskills in English and Spanish.