3) at Thermo Fisher Scientific

Plainville, Massachusetts, United States

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, ManufacturingIndustries

Requirements

High School Diploma or Equivalent
Minimum of 2 years’ experience in manufacturing/operations
Ability to lift 40 lbs. without assistance
Able to work a 12-hour rotating shift (2/2/3 rotation, 7am-7pm) in a 24-hour, 7-day per week operation including holidays
Adherence to Good Manufacturing Practices (GMP) Safety Standards and cleanroom protocols (no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair, etc.)
Ability to work in environmental conditions including cold rooms/freezers (-22°F/-6°C), laboratory setting, strong odors, hazardous/toxic materials, standing for full shift, and wearing PPE (safety glasses, gowning, gloves, lab coat, ear plugs, etc.)
Ability to perform aseptic operations
Surface level problem-solving skills
Ability to anticipate system response
Understanding of cleanroom concepts
Ability to follow directions & procedures and work in a team environment
Strong attention to detail to accomplish tasks timely, accurately, and safely the first time
Ability to apply knowledge of Good Manufacturing processes and skills in pharmaceutical processes and equipment

Responsibilities

Optimally complete work instructions while following procedures and cGMP regulations
Apply acquired job skills and company policies/procedures to complete assigned tasks
Become fully trained on all unit operations associated with the department
Work on semi-routine assignments, following established procedures and receiving instructions on new processes
Stay up to date on required job training
Maintain inventory records of raw materials used in batch manufacturing
Keep accurate and up-to-date batch records and data sheets on batches in process
Inspect finished product for adherence to specifications (appearance, foreign substances, packaging/labeling)
Assist with manufacturing batch records reconciliation
Complete assigned work tasks on time
Adhere to SOPs, Batch Records, and Work Instructions; live Quality values and hold peers accountable
Support on-time closure of Nonconformances/CAPAs
Assist in completion and identification of PPI initiatives and continuous improvements
Identify and communicate items requiring customer concern; complete post-critical issue decisions
Accurately record and analyze batches against standards, including processing data from instruments
Make approved adjustments to maintain process parameters within designated limits
Operate equipment to manufacture products; weigh, measure, and check raw materials for proper ingredients/quantities
Fully trained and proficient at manufacturing drug product injectables in cleanroom environment following GMP standards
Autonomously run equipment, pumps, and automated systems; collaborate with team to ensure right first time and on schedule
Perform operations in Support Services, Upstream, Downstream, and Fill/Finish workstreams following SOPs and Batch Records; recommend improvements
Maintain a culture of safety by identifying near misses, conducting safety walkthroughs, and assisting with resolution of safety observations
Ensure chemicals are properly stored and labeled
Spend 90% of time on the floor
May require cross-department support

Skills

Key technologies and capabilities for this role

GMPcGMPCleanroomDownstream ManufacturingUpstream ManufacturingFill/FinishSOPsBatch RecordsPumpsAutomated Systems

Questions & Answers

Common questions about this position

What is the work schedule for this position?

This is a full-time role requiring a 12-hour rotating shift (2/2/3 rotation) from 7am-7pm in a 24-hour, 7-day per week operation, including holidays.

What are the key responsibilities of this role?

Responsibilities include operating equipment to manufacture products, weighing and measuring raw materials, running equipment autonomously in a cleanroom following GMP standards, maintaining batch records, and supporting continuous improvements.

What skills or experience are required for this position?

Candidates need to be fully trained on unit operations, proficient in cleanroom manufacturing of injectables following GMP standards, able to follow SOPs and batch records, and capable of autonomous equipment operation.

What is the salary or compensation for this role?

This information is not specified in the job description.

What makes a strong candidate for this Associate III position?

Strong candidates are fully trained in department unit operations, can work autonomously on equipment in a cleanroom GMP environment, follow procedures accurately, and demonstrate a commitment to quality by adhering to SOPs and supporting continuous improvements.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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