Filling Technician

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

An Inhalation (IDD) Filling Technician is to manufacture the filled aerosol vials according to the requirements of the product, which are documented in batch record documentation and SOPs. Collects quality samples as required by the batch documentation. Assures that equipment is properly & correctly cleaned, the correct components are used per the batch record, and that all filling processes are compliant with the established methods and procedures. Ensures that all filling lots are completed to meet production timelines and goals.

Responsibilities

• Performs cleaning and clean check procedures of the filling lines
• Operates filling equipment and assures that process parameters are monitored and within range for the product being manufactured, documented in the batch record.
• Performs filling equipment change-over and set-up operations in a timely and efficient manner
• Operates filling equipment per established operating, quality, and safety practices and procedures
• Utilizes the correct cleaning procedures
• Ensures the HMI interface has the correct program selection
• Able to troubleshoot routine equipment problems and recognizes when supervision and maintenance should be notified; sets goal to minimize equipment down time per established targets
• Keeps filling equipment running efficiently and per the production plan; immediately communicates with FOT management any issues that prevent equipment from running as scheduled
• Stages and maintains supply of raw materials for an efficient and organized filling operation
• Maintains a clean and orderly work area
• Knows and uses good safety practices, takes ownership for running a safe operation, promptly communicates unsafe situations, identifies opportunities for improving safety and actively participates in safety programs
• Anticipates and plans for lot kitting, staging and filling operations for the efficient transition to the next lot
• Assures that the status of current and upcoming filling processes are communicated to the next shift’s technician
• Solid understanding and knowledge of in-process and finished product quality requirements
• Accurately records filling lot information on documents, in M.O.s, log books, labels, etc, in accordance with SOP, M.O. and cGMP requirements in pharmaceutical environment
• Sets error-free goals for their work as well as for the entire filling team; works to the successful completion of those goals
• Recognizes & communicates quality improvement opportunities that apply to the filling process
• Gives and accepts constructive feedback; provides input on the performance of operators and agency workers
• Always wears appropriate personal protective equipment (PPE) per EHS requirements when working on department processes; assures that co-workers also follow PPE requirements
  
  

Qualifications

• Excellent attention to details is essential
• Must be able to follow written and verbal instructions; able to read, write legibly, understand and communicate in English
• Must become certified in job performance within the specified amount of time allowed
• Uses a calculator and has good basic math skills including metric conversions and percentages
• Excellent teamwork & interpersonal skills, able to effectively communicate process and equipment information to co-workers and FOT management
• Physical effort involves lifting 25-65 lbs (latter on occasion); push/pull weight of approximately 310-360 lbs utilizing a dolly, when handling drums of ethanol for formulating and/or tank cleaning
• Good mechanical skills; ensures that filling equipment is correctly assembled and operating per established standards and procedures
• Uses good time management; plans daily tasks for an efficient operation and the effective use of resources
• Must be able to perform the essential functions of the position with or without a reasonable accommodation.
• Attend and participate in the Tier 1 Process.
• Proficient for basic use of D365 system to support production needs
  
  

California residents should review our Notice for California Employees and Applicants before applying.

The expected compensation range for this position represents a good faith estimate. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, & Vision, Health Savings Accounts, Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences, and 401k Benefits, etc.).

Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.

Equal Opportunity Employer

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

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