Performs those mechanical maintenance functions necessary to set up, adjust, maintain and repair production line equipment. Performs the duties and responsibilities of a production operator by following specified instructions and Standard Operating Procedures (SOP’s), to ensure that a high standard of quality is maintained during the production process. Works at a proficient level and proactively troubleshooting and recommending preventive action.
Sets up, cleans, troubleshoots, and adjusts equipment as required. Mechanical, electrical/electronic, pneumatic, and hydraulic knowledge concerning industrial equipment specific to the pharmaceutical industry. Lubricates equipment as required.
Disassembles and assembles mechanical, electrical/electronic assemblies and equipment to include repair/replacements of major components working from blueprints, assembly diagrams, electrical/electronic, pneumatic and hydraulic schematics, or other technical instructions, operate equipment as required. Mechanical, electrical/electronic pneumatic and hydraulic knowledge concerning industrial equipment specific to the pharmaceutical industry and adherence to established procedures.
Operates systems, machines, lines and equipment; e.g. vacuum systems, production machines, high pressure boilers, gas turbines, general hand tools and instruments.
Performs repairs on equipment from written instructions, sketches, plans, diagrams, verbal descriptions or self determined job requirements based on observed conditions.
Documents conditions, actions, procedures and results of work, tests or inspections performed as required by Company policies and procedures. Documents work performed on production equipment by maintaining accurate records or logs.
Maintains and upgrades technical skills through participation in training programs. Abilities to retain, understand, and apply new technical information.
Complies with SOP’s and CGMP’s through adherence to SOP’s and company policies relating to quality, safety, housekeeping, cost effectiveness. Develops and maintains SOPs for instrument calibrations.
Examines product visually for proper physical quality (i.e., properly filled, sealed, labeled, etc.). Attention to detail, alertness, skill in detecting defects.
Performs equipment cleaning as required.
Performs other duties as assigned.
High school diploma or equivalent is required.
Four years of industrial experience as a mechanic in the pharmaceutical industry or related field is preferred.
Equivalent combinations of education, training, and relevant work experience may be considered.
Outstanding attention to detail and organizational skills. Self-starter, mature, independent and dependable. Ability to work in a fast paced environment under pressure, able to multi-task and is results-oriented. Demonstrates ability to maintain a high degree of confidentiality. Effective time management and prioritization skills. Highly effective verbal and written communication skills. Ability to respond quickly to sight and sound and the ability to read gauges, dial, meters, and instructions. Those expected to weld must successfully demonstrate welding performance in accordance with Section IX of ASME Boiler and Pressure Vessel Code for shielded arc and gas tungsten arc applicable to ferrous and non-ferrous metals. Ability to tolerate stress in a safe way. Ability to motivate and energize a group of people. Demonstrated ability to manage and lead professional staff in order to achieve goals, evaluate and resolve complex technical problems.
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds, occaisionally pushing and pulling 50-100+ pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.