Sr. Manufacturing Associate Second Shift

Work Schedule

Environmental Conditions

Job Description

• Perform Drug Product manufacturing activities in classified cleanroom environments including aseptic setup material preparation formulation support filling and related operations using isolators biosafety cabinets (BSCs) and other controlled processing equipment.
• Operate monitor clean and support troubleshooting of manufacturing equipment and automated systems while following approved SOPs batch records aseptic techniques cGMP requirements and site safety procedures.
• Perform visual inspection of finished Drug Product including identification and segregation of defects completion of required documentation and support of inspection-related activities in accordance with approved procedures and quality requirements.
• Execute routine cleanroom and equipment activities such as cleaning disinfection line clearance component preparation environmental monitoring support and material transfers while maintaining proper gowning and contamination-control practices.
• Accurately complete batch records logbooks forms and other GMP documentation in real time and in accordance with Good Documentation Practices (GDP).
• Collaborate with Manufacturing Quality Engineering Validation and other cross-functional teams to support investigations deviations CAPAs equipment qualifications process improvements and continuous improvement initiatives.

• Knowledge of cGMP regulations aseptic manufacturing practices and cleanroom operations.
• Ability to operate manufacturing equipment and automated systems while following standard operating procedures and batch records.
• Strong attention to detail documentation skills problem-solving ability and effective communication in a collaborative team environment.

• While performing the duties of this job the employee:
• Ability to function in a dynamic environment and balance multiple priorities simultaneously.
• Ability to learn new software and tools quickly.
• Ability to make decisions and work with minimal to moderate supervision.
• Ability to aseptically gown and/or sterile gown as needed.
• While performing the duties of this job the employee is required to write read/review written documentation for extended periods of time. Specific vision requirements for this job include close vision distance vision color vision peripheral vision depth perception and ability to adjust focus.
• Is regularly required to talk and hear. The employee frequently is required to sit and stand for extended periods. The employee is occasionally required to lift stand; walk; use hands to finger handle or feel; reach with hands and arms; and stoop kneel or crouch.

• 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

Compensation and Benefits

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: Experience:

Senior IC