Associate III Downstream Manufacturing - 12hr. Rotation Schedule (2/2/3) at Thermo Fisher Scientific

Plainville, Massachusetts, United States

Thermo Fisher Scientific Logo
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
  • Ability to work a 12-hour rotating shift (7am-7pm, 2/2/3 rotation) in a 24-hour, 7-day per week operation, including holidays
  • Adherence to Good Manufacturing Practices (GMP) Safety Standards
  • Compliance with cleanroom requirements (no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair, etc.)
  • Ability to wear 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 and ability to accomplish tasks timely, accurately, and safely the first time
  • Ability to apply knowledge of Good Manufacturing processes, pharmaceutical processes, equipment, instrumentation, and procedures
  • Physical ability to stand regularly; use hands to finger, handle, or feel; reach

Responsibilities

  • Optimally complete work instructions while following procedures and cGMP regulations
  • Apply acquired job skills and company policies/procedures to complete assigned tasks
  • Be 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 SOP’s, Batch Records, and Work Instructions; live Quality values and hold peers accountable
  • Support on-time closure of Nonconformance’s/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
  • Be fully trained and proficient at manufacturing drug product injectables in a 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

Skills

GMP
cGMP
Cleanroom Operations
Downstream Manufacturing
Upstream Manufacturing
Fill/Finish
SOPs
Batch Records
Equipment Operation
Pumps
Automated Systems
Inventory Management
PPE

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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