Manufacturing Process Associate

Job Title 

Manufacturing Process Associate  

Organization Name 

InvaGen Pharmaceuticals, Inc., a Cipla subsidiary. 

Location 

550 South Research Place, Central Islip, NY 11722. 

May be required to work at other manufacturing units located at 7 Oser Avenue, Hauppauge, NY 11788, and 600 Old Willets Path, Hauppauge, NY 11788. 

Employment Type 

Full-time, Exempt  

Salary Range 

(Base/salary) 

$66,300 to $70,000.00 annual salary. The salary range mentioned is an anticipated base salary range for this position. The exact salary or wage rate depends on several factors such as experience, skills, education, and budget. Salary range may vary based on geographic location. In addition to the base salary/hourly wage rate, this position may be eligible for benefits and participation in a bonus program based on performance and company results. 

Notice to Applicants 

The job posting is for local applicants only. It is not for those applying for a global assignment and/or for employees working outside of Cipla's U.S. subsidiaries or affiliates. No new employment sponsorship will be provided. Relocation is negotiable for eligible candidates. 

Equal Opportunity Employer 

Cipla and its U.S. affiliates is an equal opportunity employer. The Company does not discriminate in its hiring process based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group 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 reasonable accommodation to make your application or interview experience a great one, please contact the recruiter. 

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, paid and unpaid family leave, employee discounts, and other benefits. 

Work Hours/ Shift/Remote 

General shift – 8:30 AM to 5:00 PM. 

Onsite. No remote work unless approved by Department Head and aligned with Site Human Resources (HR) Department Head in writing. 

Scope of Role 

The content and statements documented in this job description are designed to describe the general nature and level of work as well as provide a basic understanding of the role, responsibilities, and expectations of the person assigned to perform the job. This job description is not designed to provide an exact or exhaustive list of all job duties, tasks, skills, and qualifications.  

This job description intends to be representative of the knowledge, skills, and abilities needed to satisfactorily perform the essential functions of the position and in accordance with the established performance expectations.  

This position is an individual contributor who works under the direct supervision of a functional manager on most tasks and projects. Decisions may have legal and compliance implications, and/or affect the financial management and operations of the business. Work and decisions are reviewed for quality of judgment, and overall adequacy and accuracy to minimize impacts. 

Responsibilities/Accountabilities 

The Manufacturing Process Associate shall lead process capability improvement, working closely with Manufacturing, Materials, and Engineering teams to ensure internal processes are capable of providing products to satisfy customer requirements. The QE will provide focused support for daily production activities and provide guidance for technical data interpretation/analysis. 

Drive manufacturing process capability improvements through variation reduction, error-proofing, and implementation of statistical process control. 

Provide leadership on problem solving teams to drive root cause analyses and corrective/preventive action plans. 

Manage major program manufacturing process qualification. 

Validate and respond to corrective and preventive action requests (from both internal and external customers) 

Develop process flow charts/diagrams and process failure mode effects analyses reports. 

Use of lean and six sigma tools to drive variation reduction. 

Support to Operations through the product life cycle / process for defined product portfolios. 

Collaborate with cross-functional teams to identify process improvement opportunities and develop strategies for implementation.  

Conduct regular audits and assessments to identify areas for improvement and compliance. 

Collaborate with cross-functional teams to advance operational excellence objectives. 

Develop proposals for improving site process technology from a quality, cost and capacity optimization perspective. 

Management of process deviations, non-conformances, reworks, CAPA, Design Changes, complaints, scrap and change requests for product group. 

Lead Validation activities for designated product groups. 

Investigate production and product issues and consider corrective measures to make improvements. 

Prepare detailed reports of malfunctioning equipment and defective product raw materials. 

Ensure compliance with quality specifications by the inspection and testing of materials, equipment, processes, and products at different stages. 

Coordinate with the organization’s internal teams to improve product quality and meet customer requirements 

Education Qualifications 

Minimum of Bachelor’s degree (or foreign equivalent) or higher in engineering, quality /regulatory affairs, pharmaceutical sciences, or related field of study from an accredited institution required. 

Master’s degree (or foreign equivalent) in engineering, quality / regulatory affairs, pharmaceutical sciences, or related field of study from an accredited institution of preferred. 

Experience 

Minimum of 2 years of relevant experience required. 

Three or more years of relevant experience preferred. 

Preference will be given to candidates with current InvaGen Pharmaceuticals, Inc. work experience in manufacturing operations. 

Experience working in a pharmaceutical manufacturing environment required. 

General understanding and hands-on experience working with equipment, instruments, and systems involved in the manufacturing process.