Maintains the cGMP solids manufacturing facilities and equipment as per the customer's requirements. Working under limited supervision, monitors, inspects, and repairs equipment. Primary focus on operational projects, technical services, mechanical repairs and maintenance of cGMP process equipment.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Performs basic to complex service or repair work in a specialized skill area such as mechanical, electrical / electronic, hydraulics / pneumatics, plumbing, etc.
Ability to properly troubleshoot, diagnose, repair and correct processing manufacturing equipment problems
Performs all mechanical PMs on Process Equipment
Setup equipment and associated ancillary equipment related to specific campaigns. Includes preparing and receiving equipment for intersite transfers.
Perform duties using EOP / SOP departmental guidelines.
Performs all activities utilizing correct documentation practices
Interacts with all Equipment Vendors and other site support staff
Inspects specialized systems to ensure operation of equipment is within design capabilities and achieves operational conditions prescribed by client.
Knowledge of PLC and Industrial controls, sensors, switches
Responds quickly to emergency situations, summoning additional assistance as needed.
Performs variety of cleaning tasks associated with general work area cleanliness; examples include sweeping, trash collection, wash down areas, etc.
Must comply with general work requests, relative to performing GMP equipment cleaning requirements and maintenance work.
Dismantling and cleaning of GMP equipment previously used for various clinical/development processes.
Performs other general maintenance of building systems and features to assist other trades as directed.
Moves supplies and equipment as assigned.
Inventory and stocking of GMP and lab supplies.
May assist other process mechanics in performing other duties.
Complies with all company policies and procedures and adheres to company standards.
Performs all work in accordance with established specific department safety procedures.
Performs any other miscellaneous duties as requested.
No formal supervisory responsibilities in this position. May provide informal assistance such as technical guidance and/or training to coworkers. May coordinate work and assign tasks.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and EXPERIENCE
High school diploma or general education degree (GED) and a minimum of four years of related experience and/or trade school training.
Ability to comprehend and interpret instructions, short correspondence, and memos and ask clarifying questions to ensure understanding. Ability to write routine reports and correspondence. Ability to respond to common inquiries or complaints from clients, co-workers, and/or supervisor.
Requires basic knowledge of financial terms and principles. Ability to calculate simple figures such as percentages.
Ability to understand and carry out general instructions in standard situations. Ability to solve problems in standard situations. Requires intermediate analytical and quantitative skills.
OTHER SKILLS and/or ABILITIES
Uses personal computer and / or PDA for work order system, email, ESS and training. Basic skills with Microsoft Office Outlook. Physical requirements include stooping, standing, walking, climbing stairs / ladders and ability to lift / carry heavy loads of 50 lbs. or more.
SCOPE OF RESPONSIBILITY
Decisions made with general understanding of procedures and company policies to achieve set results and deadlines. Errors in judgment may cause short-term impact to co-workers and supervisor.
Internal Number: 18030448
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