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

Work Schedule

Flex 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, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials

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. Applications of 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.
• 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 assigned work tasks on time.
• Adhere to SOP’s, Batch Records, and Wok Instructions by living the Quality values every day and holds peers across the site accountable as well.
• 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; complete post critical issue 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
• May require cross-department support

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 is required, as well as the ability to work closely and effectively in a team environment.
• 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. Employee may be asked to sit continuously for a maximum of 6 hours. Specific vision abilities required by this job include close vision and ability to adjust focus with tasks.

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.

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 distributed 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  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.

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 our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: