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Thermo Fisher Scientific Associate II, Manufacturing (nights) in Cambridge, Massachusetts

Summary

Operates equipment used to manufacture products. Weighs, measures and checks raw materials to ensure that batches manufactured contain proper ingredients in proper quantities. Fully trained to and proficient at manufacturing drug product injectables in a cleanroom environment and following GMP standards. Autonomously run equipment, pumps, and automated systems and collaborate with team members to ensure it's right the first time and on schedule. Push fluids through filters in chromatography columns. Set flow paths for the operations, following SOPs and Batch records and recommending improvements.

Responsibilities

  • Effectively execute work instructions while complying with procedures and cGMP regulations. Applies acquired job skills and company policies and procedures to complete assigned task

  • Fully trained on all unit operations associated with the department. Works on assignments that are semi-routine in nature but receives instruction on new processes that are accepted practices

  • Follows established procedures on routine work, requires instructions only on new assignments.

  • Stays up to date on required job training. Assist in training staff on operations

  • Maintains inventory records of raw materials used in batch manufacturing. Keeps accurate and up-to-date batch records and data sheets on batches in process.

  • Inspect finished product to assure adherence to specifications such as appearance, foreign substances and packaging or labeling requirements as required

  • Assist with manufacturing batch records reconciliation. Complete Preventative Maintenance & work notifications tasks on time.

  • Adhere to the Quality Management Systems by living the Quality values every day and holds peers across the site accountable as well. Assist with the on-time closure of Nonconformance's/ CAPAs.

  • Assist in the completion and identification of PPI initiatives and continuous improvements.

  • Identify and communicate items requiring escalation; execute post escalation decisions. Accurately records and analyzes batches against standards all processing data gathered from instruments, etc. to ensure operating standards are met. Make approved adjustments as appropriate to maintain process parameters within designated limits.

  • Maintain a culture of safety by identification of near misses, safety walkthroughs and assisting with resolution of safety observations. Ensure chemicals are properly stored and labeled.

  • 90% of time spent on the floor

Work Hours:

  • This position will generally require the ability to work a 12-hour rotating shift in a 24-hour, 7 day per week operation to include evenings and holidays.

Education/Experience/Equivalency:

  • High school or STEM/Biotechnology certificate preferred

  • 1-2 years of specific industry experience

  • Bachelor's Degree

  • Academic or professional experience (may be demonstrated through a degree or biotechnology certificate)

  • An equivalent combination of education and experience may be considered.

Knowledge, skills and Abilities:

Grasp scientific concepts. Understand working in a regulated environment. Understand the implications of missing a clamp or a flow path and the impact to product. Knowledge of Chromatography. Knowledge of aseptic operations. Surface level problem solving skills. Ability to anticipate system response. Understand cleanroom concepts. Ability to follow directions & procedures and work in team environment. Strong attention to detail and drive to accomplish the job timely, accurately and safely the first time is required, as well as the ability to work closely and effectively in a team environment. This position will generally require the ability to work a 12-hour rotating shift in a 24-hour, 7 day per week operation to include evenings and holidays. Ability to apply knowledge of Good Manufacturing processes and the knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures. Adhere to all Personal Protective Equipment (PPE) requirements used within cGMP manufacturing.

Physical Requirements:

Employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; sit and to talk or hear. The employee is required to walk and stoop, or kneel, crouch approximately 80% of the time. The employee is required to ascend/ descend stairs approximately 20% of the time, lift a maximum of 50 lbs., and sit for a maximum of 4 hours. Specific vision abilities required by this job include close vision and ability to adjust focus with tasks.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit  www.thermofisher.com .

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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