MANUFACTURING ASSOCIATE B SHIFT

Company

We are a pharmaceutical group, founded in 1993 in Amiens (North of France), recognized for making affordable healthcare products that improve and simplify patients’ lives to as many people as possible.
With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 11 sites on 4 continents and more than 1600 employees. 
We are a dynamic company driven by a spirit of victory and are therefore pursuing strong growth while maintaining a close relationship with our customers and employees. Our culture is based on 5 values: Respect, Responsibility, Trust, Courage and Innovation. We are committed to bringing these values to life with our employees by granting them a high degree of autonomy in the exercise of their profession and by encouraging their initiatives. We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential. 

Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 280 employees.

We propose you to integrate a site that values the meaning of work and that entrusts our employees with a high level of responsibility. 

Role

Reporting to the Manufacturing Supervisor,

The Manufacturing Associate is responsible formanufacturing pharmaceutical products by setting-up, cleaning, operating, andmaintaining equipment. Executes all manufacturing processes while strictlyadhering to cGMP, Standard Operating Procedures, documentation protocols,environmental health and safety guidelines and any other related regulationsthat could apply. The Manufacturing Associate is expected to fully participatein both departmental projects and any quality working teams that may beapplicable. This position shall be responsible for the hands-on execution ofactivities as they relate to the manufacturing of products. Supports the leaderand subject matter (SME) expert in their area(s) of responsibility. Supportsproduction, operations projects, and process improvements. Maintains accurateand compliant documentation on all activities.

B. ESSENTIAL DUTIES /RESPONSIBILITIES:

Room & Process Ready for Production Run(25%)
· Prepares for production by reviewing theproduction schedule, understanding deliverables, and reviewing applicableSOP’s, and any procedure changes.
· Ensures that supplies, materials, anddocuments are available as required to meet the production schedule.
· Works with other departments to ensureadherence to production schedule.
· Receives and distributes supplies intoproduction area as necessary.
· Executes equipment qualification protocolsand validation protocols.
Product Ready for FurtherProcessing (30%)
· Operates general production equipmentensuring its proper operation and adhering to production procedures.
· Monitors and records critical processparameters.
· Documents production by completing forms,reports, logs and records of equipment and batches.
· Keeps equipment operating by followingoperating instructions, troubleshooting breakdowns, and placing work orders forrepairs. Elevates issues when work orders are placed.
· Provides input regarding opportunities forimprovement, waste reduction, etc. to supervision and/or during team meetings
· Supports implementation of processimprovement efforts, cycle time reductions, waste reductions, etc.
Equipment & Room Ready for NextProduction Run (25%)
· Prepares equipment for next run by performingcleaning. This may include manually cleaning portable equipment and smallparts.
· Performs routine maintenance and cleaning ofproduction equipment to maintain equipment in GMP fashion.
· Ensures equipment conditions are acceptableto pass to incoming shifts. Communicates any ongoing equipment, material orquality concerns to incoming teams as well as his/her supervisor.
· Ensures all paperwork is completed thoroughlyand accurately prior to the end of the shift.
Safe Work Environment (20%)
· Follows all HSSE rules and regulations.Accepts accountability for own personal safety and identifies potential unsafeconditions to help prevent self and co-workers from being injured.
· Complies with all site security requirements.
· Ensures that actions do not create a negativeimpact on the environment.

Profile