Shire Jobs

Job Description

When your part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location : Miami, Fl Site / Biologicals and Chemicals Division

3rd shift - 10:00 p.m. to 6:30 a.m*

*Shift differential is paid.

As a Manufacturing Tech II you are responsible to safely operate equipment to manufacture cell culture media and cell therapy in accordance with current Good Manufacturing Practices, including a variety of processes and packaging. Models our 4i values, integrity. Innovation, intensity, and involvement. Align with our Quality Policy by continuously improving the quality of our products & services and by ensuring global regulatory compliance. Handle materials by picking up, restocking, and ordering inventory. Experience or Proficiency with Value Streams of Packaging and Powder V Blender including weighing, Poms and Portable Fitz Mill.

What’s a typical day as a MANUFACTURING TECHNICIAN II?

You’ll be:

Dedicated to Safety, by following site safety procedures and using safety equipment as needed to complete your daily assigned work.

Using batch record instructions, job aids, standard operating procedures, and product specifications to complete production activities.

Maintain accurate documentation, records, and logs in accordance with FDA (Food and Drug Administration), GMPs (Good Manufacturing Practices) and IS09000 (International Organization for Standardization).

Perform minor troubleshooting and problem solving in areas of set-up of equipment and processes; Ability to follow testing and inspection procedures (i.e., visual inspections, in process, final product attribute). Ability to document Near Miss reports, safety opportunities, accidents, etc.

Maintain a focus on continuous improvement helping improve equipment maintenance, safety, efficiency, and throughput.

Report damage to production areas and equipment, through work orders as needed. Safety in mind, by following site safety procedures and using safety equipment as needed during your daily work. Ability to detail near miss reports, safety opportunities, accident reports, etc.

Use batch record instructions, job aids, standard operating procedures, and product specifications to complete production activities.

Maintains accurate documentation, records, and logs in accordance with FDA (Food and Drug Administration), GMPs (Good Manufacturing Practices) and IS09000 (International Organization for Standardization).

Ability to follow testing and inspection procedures (i.e., visual inspections, in process, final product attribute).

Maintains a focus on continuous improvement helping improve equipment maintenance, safety, efficiency, and throughput.

Ability to report damage to production areas and equipment, through work orders as needed. Rework and re-packaging of materials as needed. Perform the specified cleaning of manufacturing equipment in liquid and/or powder.

As needed, maintain the stocking levels for gowning, consumables, cleaning products, and other manufacturing supplies.

Working with the team to achieve operational goals while being engaged in the process.

Presenting issues and concerns to supervisor or designee.

Powder Manufacturing [Dependent on skill specialization]

Experience in set-up and operate semi-manual and manual powder processing and packaging equipment.

Ability to load IBCs (Bins) with raw materials (ROHs) and gross weighing’s for IBCs (Bins).

Perform weighing processes in manual and automated powder packaging processes.

Ability to cover all aspects of powder packaging, including material handling, weighing the materials, setting-up of equipment, and operating the equipment (both manual and semi-automated processes).

Liquid Manufacturing [Dependent on skill specialization].

Ability to set-up and operate liquid compounding tanks and perform liquid compounding processes.

Set-up, operate and perform the liquid manual and automated bottle filling and packaging equipment and processes.

The set-up and perform the liquid bag filling and packaging process.

Ability to set-up and operate sterilization processes, including autoclave sterilization, filter sterilization and Steam-ln-Place (SIP) processes. Also, to qualify in aseptic gowning techniques.

General - Physical and Environmental Requirements:

Work in a controlled manufacturing environment; is required to lift 25 lbs. may be required to stand for long periods of time while performing duties. Ability to work safely with materials and equipment.

Expose to fumes and chemicals such as raw materials, cleaners, etc.

Potential for overtime and flexible shifts*.

Various levels of gowning are required.

Emergency overtime may be required with little notice to ensure operational objectives.

Your Knowledge and Experience:

General understanding of machinery and mechanics is required.

Knowledge of computer applications and current software.

High school diploma with 2 years of experience in GMP and experience with similar equipment.

Technical Proficiencies :

Experience and understanding of E1 platform SAP.

Learn and demonstrate an understanding of PPI (Practical Process Improvement). Identifying and calling out technical problems.

Manufacturing Competencies:

Process knowledge; communication and risk issue and operational understanding

At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has an outstanding story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner, and safer.

We offer an excellent Benefits Package

· Review our company’s Total Rewards (https://jobs.thermofisher.com/global/en/total-rewards)

· Medical, Dental, & Vision benefits-effective Day 1

· Paid Time Off & Holidays

· 401K Company Match up to 6%

· Tuition Reimbursement – eligible after 90 days!

· Employee Referral Bonus

· Employee Discount Program

· Recognition Program

· Charitable Gift Matching

· Company Paid Parental Leave

· Career Advancement Opportunities

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

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.