Sr. Pharmaceutical Maintenance Technician - 3rd Shift

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

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Job Summary

The Senior Manufacturing Maintenance Technician is accountable for driving results in a fast-paced environment by directly supporting a wide range of service disciplines covering HVAC systems, mechanical and electrical troubleshooting, mechanical equipment repair and general maintenance in an FDA registered pharmaceutical processing environment. The Sr. Manufacturing Maintenance Technician operates in a highly technical fast paced environment requiring experience related specifically to keeping production business running. The Sr. Manufacturing Maintenance Technician applies critical thinking and considers all business impact aspects before taking job related actions that could cause unwanted consequences such as loss of revenue, unsafe events, and other risks. The technician can apply independent judgment and perform in a small company environment, where rapid changes occur constantly.

On-Site Expectations

• 100% on-site position in Charleston, SC.
• 3rd Shift: Sunday - Thursday, 11:00pm - 7:30am.

Responsibilities

• Performs scheduled P.M.’s on equipment and records all necessary data as required and in accordance with Company SOP’s and cGMP’s.
• Assists in installation and retrofit of facilities equipment in accordance with Company SOP’s and cGMP’s.
• Ensures Maintenance Management informed of all developments on a routine basis.
• Performs necessary repairs to equipment and physical plant as required in a safe, clean, and efficient manner to response to maintenance work requests.
• Troubleshoots equipment as necessary, working with equipment owners, engineers, and equipment vendors. Involved in developing solutions for equipment issues.
• Completes required paperwork and documentation, work orders and GMP documents in a clear, accurate and in a timely manner. Develop and encourage good interpersonal working relationships among Facilities staff and with other customer departments (internal and external).
• Maintain an organized and clean workspace at all times.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Is on call periodically to monitor and respond to facility and manufacturing equipment repairs and issues.
• Other duties as assigned.

Qualifications

• 2-5 years of experience working in a regulated environment (FDA, NRC or similar performing repairs on production and/or utility equipment).
• High school diploma or equivalent. Associate degree preferred.
• Prior pharma cGMP experience required.

Knowledge, Skills, and Abilities

• Excellent verbal communications and presentation skills required.
• Basic mechanical and electrical troubleshooting required.
• Strong understanding of Standard Operating Procedures required.
• Ability to read P&ID’s and electrical schematics required.
• Working knowledge of Microsoft Office (Word, Excel, PowerPoint) required.
• Working knowledge of cGMP in a pharmaceutical or regulated environment preferred.
• Working knowledge of Control Systems, PLCs & HMIs preferred.
• Working knowledge of Computerized Maintenance Management Systems to schedule and document work performed preferred.
• Working knowledge of general OSHA safety requirements preferred.
• Working knowledge of Building Management System preferred.

Travel Expectations

• Up to 5% travel expected.

Physical Demands and Work Environment

The physical demands and work environment characteristics described here are representative of those that must be met or encountered by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to walk; climb or balance and stoop, kneel, crouch, or crawl. The employee is occasionally required to sit. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, occasionally lift and/or move up to 80 pounds and occasionally lift and/or move over 100 pounds with assistance. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration.

The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. Other tasks involving elevated work may require the use of a body harness and lanyard. Additionally, the employee may be required to operate an industrial vehicle.