DPI Manufacturing Operator II - 3rd Shift

Cipla•Hauppauge, NY

2d•Onsite

About The Position

The DPI Manufacturing Operator II is responsible for performing all functions according to current Good Manufacturing Practices (cGMP) and company Standard Operating Procedures (SOP). This role involves accurately documenting in Manufacturing Batch Records and Logbooks, determining when to stop a line for safety or quality reasons, and obtaining/weighing products for all shifts. The operator will move raw materials and product, inspect machine parts, operate equipment for pharmaceutical product manufacturing, and perform quality checks on product attributes. They will also submit samples to quality labs, maintain records, assist in running validation batches, monitor the production process, and make adjustments to maximize efficiency, yields, quality, and safety. Accurate reporting of production is essential. The role includes performing operator-level machine adjustments, assisting technicians with minor repairs and set-up, and troubleshooting equipment problems. The operator must immediately stop manufacturing and notify a supervisor of any safety or quality concerns. Responsibilities also include line cleaning, segregating waste, returning unused materials, disassembling, cleaning, and reassembling basic line equipment, and ensuring proper inspections are conducted. Participation in safety programs and adherence to safety regulations and environmental policies are required. Other duties may be assigned by Manufacturing Management.

Requirements

High School Diploma
2 years Manufacturing Operator experience in an automated work environment preferred.
Knowledge of current Good Manufacturing Practices (cGMP), Manufacturing Area Standard Operating Procedures and Food and Drug Administration (FDA) regulations
Ability to communicate effectively and clearly, both written and verbally in English
Comply with safety and quality regulatory standards.
Ensure products are Manufactured in accordance with CIPLA/InvaGen standards.
Works independently with minimal supervision once assignments or responsibilities outlined and delegated.
Displays a strong sense of ownership for work.
Flexible and Adaptable: Coping with ambiguity, change and uncertainty effectively. Not hesitant to resolve lack of clarity, structure or definition of outcomes then moves ahead.
Action and Results Oriented: Demonstrates initiative, sense of urgency and bias for action. Self-motivated, naturally proactive with high energy level when addressing work tasks.
Communication: Communicates effectively orally and verbally with supervisors and peers. Maintains and internal and external customer focus.
Organized and Timely: Uses organization and good time management skills. Ensures tasks are completed within set deadlines. Works effectively in a multitask environment and consistently tracks the progress of ongoing initiatives.
Prioritizes and Implements: Identifies issues and opportunities, prioritizes, and successfully implements them. Uses cognitive skills and processes to arrive at sound decisions and solutions.
Logical Thinking and Analysis: Assimilates diverse information and proactively presents solutions through detailed analysis. Balances logic and intuition to arrive at well-founded decisions tempered by practicality and common sense.
Relationship Builder: Builds productive, trusting, respectful relationships at all levels in the organization. Understands and values the perspectives of others by working in teams.
Continuous Improvement Focus: Continually strives to learn more to improve self. Sets high standards for work and work relationships. Actively seeks and supports continuous improvement activities in process efficiencies, costs, and effectiveness of work.
Effective Conflict Resolution Skills: Using tact and diplomacy is effective in resolving differences and conflicts within the organization. Good listener who takes care to understand the words of others, asking questions and actively acknowledges key points.
Team Player: Consistently acts as a member of the team.

Nice To Haves

2 years Manufacturing Operator experience in an automated work environment

Responsibilities

Perform all functions according to current Good Manufacturing Practices (cGMP) and company Standard Operating Procedures (SOP).
Accurately and legibly document in Manufacturing Batch Record and Logbook.
Determine when to stop a line related to a safety or quality issue.
Obtain and weigh in products for all shifts.
Move raw materials and product to/from vault, cage, process, or storage areas.
Inspect machine parts for unusual wear and proper lubrication.
Operate equipment required in the manufacture of pharmaceutical products.
Perform/review quality checks on weight, thickness, hardness, and friability of Product at various stages of the process according to manufacturing instructions and SOPs.
Submit product samples to quality laboratories as required.
Maintain product batch, room activity, and equipment records.
Assist in running validation batches.
Monitor the production process, make periodic checks, and adjust equipment or work practices to maximize production efficiency, yields, quality, and safety.
Accurately report production and ensure reports are completed as required.
Perform operator-level machine adjustments and lubrication.
Assist technicians with minor machine repairs and set-up.
Troubleshoot problems with equipment and processing to assist other technicians to minimize disruptions to production.
Immediately stop manufacturing and notify Line Leader or Supervisor of any safety or quality concerns.
Perform line cleaning.
Segregate waste product and materials.
Return unused material/product.
Disassemble, clean, and reassemble basic line equipment according to SOPs.
Ensure proper inspections are conducted prior to reassembly.
Participate in safety related programs and/or safety teams as needed.
Enforce and follow safety regulations and ensure working area is clean.
Adhere to CIPLA’s Safety, Health, and Environmental policies.
Perform other duties assigned as required by Manufacturing Management.