Job Description

Job Title
MDI Operations Specialist
Organization Name
InvaGen Pharmaceuticals, Inc.
Location
Fall River location
Employment Type
Full Time
Shift
Second Shift
Salary Range (Base/ Hourly)
$72,800 - $93,600
Benefits
In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance - medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) - vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, employee discounts, and other benefits.
Work Hours/ Shift/ Remote
Third Shift: 11:00 PM - 07:30 AM (may vary based on business needs)
Responsibilities/ Accountabilities
Assist in the coordination of daily packaging activities to meet production schedules of projects.

• Monitor packaging processes for adherence to cGMP, FDA, and Cipla's quality standards.
• Identify and resolve operational inefficiencies, escalating complex issues when necessary.
• Ensure proper documentation of batch records, logs, and deviations.
• Monitor production schedules to ensure timely execution and minimize delays to support ongoing projects.
• Assist in investigating deviations, non-conformances, and CAPAs (Corrective and Preventive Actions).
• Work closely with Quality Assurance (QA) to ensure adherence to standard operating procedures (SOPs).
• Assist in coordinating materials, equipment, and workforce allocation for optimal resource utilization.
• Identify areas for operational improvements, focusing on reducing waste and enhancing efficiency.
• Assist in implementing new technologies and automation in production workflows.
• Collaborate with Team, Quality, Supply Chain, Project Management, Engineering, and R&D teams to resolve operational bottlenecks
• Support training efforts by ensuring clear communication of standard operating procedures (SOPs)
• Monitor operational metrics such as efficiency, compliance rates, and resource utilization.
• Identify areas for improvement in packaging activities and contribute to process enhancements.
• Support initiatives aimed at improving overall productivity through data analysis and performance reviews.
• Develop and maintain strong professional relationships with suppliers/vendors to ensure compliance with quality standards and timely delivery of goods and services.
• Create and manage purchase requisition (PR) using SAP for services, contracts, equipment, consumables, and miscellaneous items, ensuring accuracy & alignment with end-user requirements.
• Maintain clear and effective communication with internal and external stakeholders to address issues, facilitate smooth operations, and ensure alignment with project strategies.
• Follow strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Packaging Practices (cGMP).
• Participate in safety related programs and or safety teams as needed.
• Enforce and follow safety regulations and ensure that their working area is clean.
• Adhere to CIPLA's Safety, Health, and Environmental policies.
• Other duties assigned as required by Reporting management / Dept. Head.

Education Qualifications
Bachelor's degree in pharmaceutical sciences/ electrical/ mechanical / production or related fields of study.
Experience
5-11 years of experience in packaging, operations, team management. Preference will be given to candidates with experience in pharmaceutical MDI packaging.
Skills/ Competencies

• Understanding of cGMP, FDA regulations, and pharmaceutical packaging processes.
• Experience in SAP system and packaging data analysis tools.
• Strong problem-solving abilities, attention to detail, and ability to work in a fast-paced, regulated environment.
• Excellent communication skills, drive, and sense of urgency
• Excellent computer skills, specifically Microsoft Office Suited.
• Follow strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Packaging Practices (cGMP), complying with legal regulations, monitoring the environment.
• Knowledge of pharmaceutical packaging and related documents.
• Knowledge and experience writing, revising, and creating cGMP records and SOP's.
• Experience with quality system compliance.
• Ability to work effectively both independently and as part of a team.
• Capable of handling and participating in compliance and regulatory audits at the local and federal levels.
• Experience in Inhalation products (Metered Dose Inhaler) is a plus.

Physical Demands

• Stand or walk for extended periods of time.
• Reach with hands and arms.
• Use fingers to handle or feel.
• Ability to lift up to 50lb when required.
• Safety/Personal Protective Equipment (PPE) required for this job.

GLOBAL COMPANY:
Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world.
Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.
CIPLA FALL RIVER (INVAGEN PHARMACEUTICALS, INC.):
About InvaGen Pharmaceuticals, a Cipla subsidiary InvaGen Pharmaceuticals, Inc. is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on metered dose inhaler.
InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.
EEO STATEMENT:
Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, genetic information, disability, or protected veteran status.
At Cipla, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact .
PRE-EMPLOYMENT PROCESS:
Applicants who receive a conditional offer must satisfactory complete pre-employment drug testing.
DISCLAIMER ON PAY RANGES:
About the Salary/ Pay Range: The salary range mentioned above is an anticipated base salary range for this position. Exact salary depends on several factors such as experience, skills, education, and budget. Salary range may vary based on geographic location. In addition to base salary, this position may be eligible for benefits and participation in a bonus program based on performance and company results.

Skills Required