Cell Culture Technician

POSITION SUMMARY

Perform operations in a line team environment to provide high quality pharmaceutical products on time and in the right quantities to customers.

POSITION DUTIES & RESPONSIBILITIES

• Incumbent will be expected to train and become qualified in all required and preferred skill areas within a reasonable period of time.

• Comply with all workplace standards and safety procedures, including Lockout Tagout, Current Good Manufacturing Practices (cGMPs), Occupational Safety and Health Administration requirements (OSHA), Standard Operating Procedures (SOPs), and Company Guidelines.

• Perform equipment setup and changeover activities. Take action to safely reduce equipment setup and changeover times.

• Initiate and establish equipment operating parameters to maximize production, while meeting all product specifications.

• Coordinate the utilization of outside contractors and vendors as needed.

• Perform the daily setup and routine operation of the packaging line, including but not limited to: bottle in-feed, unscrambler, filler, bottle capper, torquer, labeler, vision systems, weighing systems, bar coding systems, sealers, disassembly/assembly, cleaning, resolving equipment stoppages and jams, and all material handling as trained.

• Perform preventive maintenance tasks as needed and trained.

• Troubleshoot Variable Frequency Drives and Servo Drive systems as trained.

• Inspect packaging components, in-process items, and packaged drug products to assure compliance to specifications, identify any non-conforming item and initiate appropriate actions.

• Palletize both finished and unfinished products, and operate motorized and non-motorized material handling equipment.

• Complete, maintain, and update production documentation (both electronic and paper) to perform material movements, material take-outs and yield determinations by following SOPs and utilizing systems as required such as Systems/Applications/Products (SAP), Manufacturing Execution Systems (MES), Electronic Batch Records (EBRs), etc.

• Take ownership of training and learning to develop high performance competencies such as technical skills, communication skills, and skills to build a team-oriented culture (i.e. training team members, motivating and supporting team members, sharing knowledge to continuously improve the process, etc.).

• Meet the production schedules outlined by line team and/or Supervision. Review and approve work output for team members by using validated methods.

• Perform other duties as trained and assigned.List all Equipment/Machinery used in position:

• Forklift, walkie stacker, hand pallet jack, bottle hopper and unscrammbler, fillers, cottoners, capper hopper and capper, labelers, enercons, retorqers, cartoners, case packers, palletizers, debottler, hand tools, conveying equipment

REQUIREMENTS/PREFERENCES

Education Requirement(s):

• High School Diploma or GED required.

Skill & Competency Requirements:

• Good written and verbal communication skills in English required.

• Must be willing to work overtime as required, based on production demands.

• Must be willing to work different shifts to support business demands and training needs.

• Demonstrated ability to read/interpret/follow instructions in regard to workplace documentation, such as SOP’s, Operator Manuals, Work Instructions, etc.

• Must be able to demonstrate a good mathematical aptitude in addition, subtraction, multiplication, division, & metric system.

• Must be cleared to perform the occupational and physical demands of the Assoc Technician job description."