Validation Technician / Production

Position Summary:

• Responsible for setting up, operating, and maintaining the production filling and filling support

equipment.

• Responsible for assembling and testing manufactured goods to ensure products are working exactly as

intended and are free of defects or others issues.

Essential Duties & Responsibilities:

• Set-up and operate solution filling lines, vial cappers, and tray loading lines.

• Perform fill weight checks and bottle torque checks on filled product containers.

• Set up and perform sterile solution filtration processes.

• Unloading racks of sterilized equipment from autoclaves and depyrogenated glassware from ovens.

• Operate autoclaves, both for sterilization of equipment and for terminally sterilizing product.

• Operate vial and ampoule washers, in conjunction with dry heat ovens to prepare the components for

aseptic processing.

• Clean and prepare filling gear/equipment for use on multiple filling operations.

• Completion of batch record paperwork, as well as reviews of applicable SOP's and other pertinent

documentation.

• Maintain a clean and sanitary environment.

Additional Responsibilities:

• Supporting new equipment validation efforts.

• Performing supervisory duties in supervisor's absence or in second shift manufacturing.

• Training new employees for all job duties.

Education and Experience:

• High school diploma or general education degree (GED)

• Two years related pharmaceutical experience and/or training.

PRODUCTION TECHNICIAN II

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• Equivalent combination of education and experience.

• Advanced mechanical training is a plus.

Job Prerequisites:

• Ability to meet attendance standards. All full-time employees are required to work a 40-hour week. At

times it may be necessary to work additional hours in order to get the required tasks accomplished to

meet deadlines.

• Become certified to work in cleanrooms for the purpose of aseptic filling.

• Demonstration of superior mechanical aptitude in set up and maintenance of pharmaceutical

manufacturing equipment is a must.

• Ability to interact with peers and operators to be part of the team.

• The cleanroom manufacturing environment requires personnel with good personal hygiene.

• Adaptability to change and to perform under pressure with time constraints.

Physical Demands:

• While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk, and

hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required

by this job include close vision for written work and PC use.

• A large amount of time will be spent standing or walking, stooping, kneeling, or crouching.

• The employee must regularly lift objects up to 10 lbs. and pushing carts in excess of 500 to 1000 lbs. is

necessary.

• Lifting baskets with product weighing 10-20 lbs.

Mental Requirements:

• Ability to hear accurately the spoken word with moderate office noise or plant noise;

• Ability to apply deductive reasoning and understand complicated issues;

• Ability to receive instructions and follow work rules and company policies;

• Ability to follow safety and security practices;

• Ability to meet deadlines and effectively deal with office stress;

• Ability to accurately communicate ideas, facts, and technical information; and

• Maintain confidentiality of certain information.

Work Environment:

• Exposure to moving mechanical parts.

Job Type: Full-time

Pay: $46,553.69 - $49,000.00 per year

Benefits:

• 401(k)

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work Location: On the road

Salary : $46,554 - $49,000