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

Thermo Fisher Scientific • Plainville, MA

39d • $23 - $38 • Onsite

About The Position

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.

Requirements

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

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

Benefits

• annual incentive plan bonus scheme
• healthcare
• employee benefits
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees