In this role, you will operate a variety of processing and packaging equipment to manufacture cell culture media in accordance with current Good Manufacturing Practices. This role resides in our Liquid Filtration department, which is primarily responsible for setup and operation of filling equipment for routine aseptic processes, performance of filling tasks with proper aseptic technique to prevent negative Safety and Quality product impact and monitoring/maintenance of production equipment to ensure continued operation. Duties of this role are primarily completed in a controlled clean room environment. Individuals in this role are required to maintain gowning qualification in order to operate in clean room environment. This role requires: strong application of aseptic technique, ability to complete production documentation according to cGMP guidelines, ability to operate in gowning equipment for long periods of time and successful annual completion of media fill validation to maintain aseptic filling qualification.

Scope of Role:

In the Operator II role you will be expected to complete moderately complex tasks and routine assignments through application of technical and procedural knowledge, including:

· Following SOPs to perform moderately complex tasks (sometimes technical in nature)

· Using experience and logic to solve routine to moderately complex problems within process guidelines

· Adjusting to changes in work volume

· Escalating all deviations to a Lead/Supervisor

· Interacting within a team

Essential Functions:

In this role you may complete some or all of the following duties:

· Sets up and operates filling equipment for routine aseptic processes

· Performs filling tasks with proper aseptic technique to prevent negative Safety and Quality product impact

· Operate processing and packaging equipment to manufacture cell culture media. Equipment includes mixers, mills, blenders, pumps, filtration systems, and packaging equipment.

· Weigh, measure and check raw materials with assistance of computer interface to assure batches manufactured contain proper materials and quantities.

· Calibrate/operate semi-automated and automated manufacturing equipment.

· Perform in-process sampling and testing to assure batches meet specification.

· Follow all safe practices and SOP’s.

· Complete and maintain Quality Records in compliance with regulatory requirements, GMP’s and standard operating procedures.

· Maintain equipment and rooms in proper operating condition and proper cleanliness requirements.

· Perform activities in a controlled environment up to and including classified clean room conditions.

· May be required to perform other related duties as required and/or assigned.

Job ID: 52959BR

Education:

Requires a high school diploma or equivalent.

Experience:

General understanding of machinery and mechanics is required. Strong attention to detail required.

Experience working with a strong focus on quality of product required. Prior experience in a GMP manufacturing environment is preferred. Knowledge of computer applications and current software is desirable.

Working Conditions:

Works in a controlled manufacturing environment; is required to lift up to 45 lbs. and may be required to stand for long periods of time while performing duties. Must be able to work safely with materials and equipment. Must be able to work overtime and flexible shifts. Various levels of gowning are required.

Responsible for the manufacturing, assembly, and/or packaging of BioProcess Containers in a clean room environment. Technicians carry out the production process by closely following the Standard Operating Procedures, Work Instruction Documents and blueprints or drawings as they relate to assembly, materials handling, equipment operation, and finished goods packaging

This position requires following cGMP (Current Good Manufacturing Practices) and working in a fast paced team environment

Key Responsibilities: (Include but are not limited to the following)

Following all safety requirements and cGMP requirements
Following work instruction document, standard operating procedures and standard works
Assembling product using specific written instructions, blueprints and drawings
Record correct and accurate documentation in Production Control Documents
Perform inspection of in-process and finished product
Participate in PPI (Practical Process Improvements), Lean and Continuous Improvement activities including 5S activities
Assist in training function of co-workers and mentoring
Daily Schedule adherence

Job ID: 55277BR

Must Have Hiring Criteria:

HS Diploma or equivalent

Physical and Environmental Requirements:

Ability to work in a fast paced controlled cleanroom environment up to 8 hours a day with additional overtime as required
The Clean-room is controlled at greater than 30% humidity with a temperature between 60º and 70º
The Clean-room has some ambient noise.
Specific gowning is required including: gloves, hair & beard net and face cover, safety glasses with no makeup / jewelry, and the like.
Position requires forceful gripping/grasping and repetitive motion including pushing and pulling
Ability to use PPE (Personal Protective Equipment) and understand chemical hygiene including labels and SDS (Safety Data Sheets), common chemicals are disinfect, solvents and IPA (Isopropyl Alcohol 70% and 99%)
Ability to stand and move about including reaching, bending, stooping, grasping
Ability to use hand tools and equipment including forceful gripping, grasping, pushing, pulling and repetitive motion
Ability to infrequently lift and manipulate up to 40 pounds unassisted

Job ID: 52027BR

When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $20 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.
Sr Manufacturing Planner/Scheduler

ESSENTIAL FUNCTIONS:

Manage internal build schedule and release of work orders
Evaluate and execute work order changes resulting from review of detailed engineering change orders; evaluate impact to production work orders, purchase orders, sales order fulfilment and field installation impact, ensuring effective communication with engineering, production mgmt. and buyers/suppliers
Determine raw materials needed to cover production demand, working closely with other Planners to ensure manufacturing plan cohesiveness and address issues in a timely manner when they arise
Collaborate with other department members, and quality control, warehouse, and other staff to plan and prioritize procurement, inspection, and material movements to ensure maximum performance and minimum delay
Tactical materials resource planning; build to order environment requires high level of planner intervention to ensure accuracy and timeliness.

ESSENTIAL SKILLS AND EXPERIENCE:

Proven experience as a production planner with knowledge of quality control principles; minimum of 5-10 years’ experience in a similar manufacturing environment; 2-5 in a Senior role.
Strong organization and problem-solving skills
Advanced communication and computer skills.
Minimum AS degree – Bachelors degree desired

BENEFICIAL/DESIRED SKILLS AND EXPERIENCE:

Proficiency with MS Excel required