Manufacturing Technician IV

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** Manufacturing Technician IV
** leads others in a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set inclusive of current GMP/ISO requirements and standards and following all safety guidelines of PCI. With general supervision, the technician leads and performs all manufacturing operations including but not limited to work functions in equipment prep, dispensing, dissolution, formulation, purification, aseptic compounding, filling and packaging activities for biopharma and medical device products.

Addresses non routine matters. Utilizes technical knowledge and experience to resolve complex manufacturing problems. Monitors personnel interaction to ensure proper behaviors. Escalates matters requiring resolution by management. Works with, reviews and revises master production records and standard operating procedures. Trains and guides less experienced personnel. Is a model of the Guardian values and behaviors.

Essential Duties and Responsibilities:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The basic duties and responsibilities include the following, but other duties may be assigned.
* Maintains and adheres to safe work habits and all applicable PCI safety procedures and guidelines. Is proactive in identifying safety risks and alerts management to take corrective action.
* Leads team to accomplish daily tasks
* Maintains weekly/daily schedule up to date and provides direction to team
* Accountable for completing daily tasks and reporting issues to management
* Works with management to provide a positive culture within operations
* Mentors less experienced staff in the performance of aseptic techniques
* Prepares solutions, aseptic filling and labeling of vials under sterile and non-sterile conditions, routine solution and filtration, vial and component preparation and sterilization
* Assembles, disassembles and operates aseptic filling equipment and lyophilizer equipment in classified cleanroom and controlled non classified environments. Operates vial capper, unloads product from lyophilizers and liquid fill line.
* Prepares equipment and components for sterilization and Lyophilization
* Operates processing equipment including autoclaves, ovens, vial washers, and depyrogenation, centrifuges, mills equipment.
* Assists in the formulation and dispensing of product in a clean room environment per SOPs and MBRs
* Sanitizes production areas and prepare equipment for production
* Completes, maintains and reviews documentation related to assigned work, including logbooks, batch records, etc.
* Trains and ensures proper training within the team prior to assigning tasks
* Troubleshoot and resolve problems with equipment or processes in the course of performing job duties
* Adheres to verbal instructions and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation
* Identifies, escalates and documents events that deviate from normal operation; perform investigations as needed
* Maintains compliance, cleanliness and orderliness of operational areas per appropriate SOPs
* Performs COP, CIP, and SIP operations to prepare equipment for manufacturing operations
* Demonstrated understanding of sanitization and sterilization practices (build, clean and sterilize equipment to support production operations
* Inspire and constantly strive to make PCI a great place to work and respected for the quality of its people and products and clients
* Successfully participates in media fill/aseptic proficiency test

Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

* Requires a high school diploma with 4+ years of cGMP Pharmaceutical experience to include finished dose form
* 4+ years of working experience in the pharmaceutical or medical device industry.
* Strong knowledge of aseptic techniques and fill finish experience required
* Experience in reviewing and creating controlled documents
* Detail oriented with strong mechanical aptitude
* Positive attitude and strong interpersonal skills to resolve and de-escalate issues.
* Honesty, integrity, respect and courtesy with leadership and peers
* Strong commitment to conducting PCI business according to the highest legal and ethical standards, and to continually pursue excellence in the manufacturing and delivery of PCI products and services
* Resilient, can quickly move forward despite challenges,…