Associate III Downstream Manufacturing - 12hr. Rotation Schedule (2/2/3)

Job Opportunity

Work Schedule: 12 hr shift/days

Environmental Conditions: Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description: Operating equipment is used to manufacture products. Weighs, measures and checks raw materials to ensure that batches manufactured contain proper ingredients in proper quantities. Fully trained 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. Perform operations in Support Services, Upstream, Downstream, and Fill/Finish workstreams following SOPs and Batch records and recommending improvements.

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 holidays. This role is a 1st shift, 7am-7pm shift (2/2/3 Rotation).

Responsibilities:

• Optimally complete work instructions while following procedures and cGMP regulations.
• Fully trained on all unit operations associated with the department.
• Follows established procedures on routine work.
• Stays up to date on required job training.
• 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.
• Assist with manufacturing batch records reconciliation.
• Complete assigned work tasks on time.
• Adhere to SOP's, Batch Records, and Work Instructions by living the Quality values every day.
• Support 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 customer concern.
• Accurately records and analyzes batches against standards.
• Make approved adjustments as appropriate.
• Maintain a culture of safety.
• Ensure chemicals are properly stored and labeled.

Education/Experience/Equivalency Requirements:

• High School Diploma or Equivalent
• Minimum of 2 years' experience in manufacturing/operations

Knowledge, Skills and Abilities:

• Ability to perform 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 aim to accomplish the job timely, accurately and safely the first time.
• 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 up to 50% of the time.
• The employee is required to ascend/ descend ladders, and push, pull, or lift a maximum of 50 lbs.
• Specific vision abilities required by this job include close vision and ability to adjust focus.

Compensation and Benefits:

The hourly pay range estimated for this position based in Massachusetts is $23.02–$38.36. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that includes:

• A choice of national medical and dental plans, and a national vision plan.
• Employee assistance and family support programs.
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave.
• Accident and life insurance, and short- and long-term disability.
• Retirement and savings programs.
• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount.

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.