Manufacturing Specialist (MDI Operations) – 1st Shift

Shifts:

• 1st Shift: 7:00 AM – 3:30 PM
• 2nd Shift: 3:00 PM – 11:30 PM (based on business needs)

Relocation Assistance: Available for qualified candidates
Visa Sponsorship: Not Available (Only US Citizens or Green Card Holders)

About the Role

We are seeking an experienced Manufacturing Specialist (MDI Operations) to join our pharmaceutical production team in Fall River, MA. This role is ideal for professionals with 5–11 years of packaging or operations experience in a regulated pharmaceutical, nutraceutical, or medical device manufacturing environment.

The Manufacturing Specialist will oversee and support daily MDI packaging operations, ensuring full compliance with cGMP, FDA regulations, and SOPs while driving process efficiency and continuous improvement.

Key Responsibilities

• Coordinate and oversee daily packaging activities to meet production schedules.
• Monitor MDI packaging processes for compliance with cGMP, FDA, and internal quality standards.
• Identify, troubleshoot, and escalate operational issues or inefficiencies.
• Ensure accurate documentation of batch records, logs, and deviations.
• Collaborate with Quality Assurance, Supply Chain, Project Management, and Engineering to resolve operational challenges.
• Assist in investigations of deviations, non-conformances, and CAPAs.
• Support resource allocation, equipment coordination, and material planning to optimize workflow.
• Prepare purchase requisitions (PR) in SAP for equipment, consumables, and services.
• Participate in performance reviews and data-driven productivity initiatives.
• Assist in implementing automation and process improvement technologies.
• Support staff training and ensure consistent SOP compliance.
• Maintain strong vendor relationships to ensure timely delivery of materials and compliance with standards.
• Follow all safety protocols, maintain clean working areas, and participate in safety programs.

Qualifications

• Bachelor’s degree in Pharmaceutical Sciences, Electrical, Mechanical, Production, or related field (required).
• 5–11 years of relevant experience in pharmaceutical, nutraceutical, or medical device packaging/operations (required).
• Prior experience in MDI (Metered Dose Inhaler) operations (preferred).
• Strong understanding of cGMP, FDA regulations, and pharmaceutical packaging processes.
• Experience with SAP and data analysis tools.
• Proficient in Microsoft Office Suite (Excel, Word, PowerPoint).
• Excellent problem-solving, communication, and organizational skills.
• Knowledge of creating and revising SOPs and cGMP records.
• Experience with quality system compliance and regulatory audits.
• Ability to work effectively in both independent and team settings.
• High attention to detail and strong sense of urgency in meeting production goals.

Physical and Safety Requirements

• Ability to stand or walk for extended periods.
• Reach with hands and arms and handle materials as needed.
• Must be able to lift up to 50 lbs when required.
• Use of PPE is mandatory, including gloves, goggles, and other protective gear as needed.

Benefits

Employees enjoy a comprehensive benefits package that includes:

• Competitive salary with performance-based growth
• 401(k) savings plan with employer match
• Health, dental, and vision insurance
• Health Savings Account (HSA) and Flexible Spending Account (FSA) options
• Paid Time Off (vacation, sick, and flex days)
• Paid holidays
• Short-term and long-term disability (STD/LTD)
• Parental leave
• Employee discounts and other wellness benefits

Why Join Us

This is an exciting opportunity to join a world-class pharmaceutical manufacturing organization that values innovation, safety, and quality. You will play a key role in supporting the production of inhalation-based pharmaceutical products that improve lives worldwide.

Job Type: Full-time

Pay: $72,800.00 - $93,600.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Employee discount
• Health insurance
• Paid time off
• Parental leave
• Vision insurance

Work Location: In person