Production Technician (Maintenance) - Lyo

Employer
Merck
Location
Durham, NC, US
Posted
April 17 2018
Discipline
Other
Organization Type
Pharma
Requisition ID: PRO017085

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. The Vaccine Manufacturing Facility Operations Technician role is a multi-faceted position. The successful candidate will be the subject matter expert (SME) and use their maintenance expertise to ensure that all equipment is running at optimal levels at all times. The Operations Technician will be responsible for all aspects of product manufacturing and equipment maintenance to include preventive maintenance as well as troubleshooting and repair. This is an excellent opportunity for experienced mechanics, recent graduates of technical degree programs, or mechanically talented persons with cGMP manufacturing and leadership experience. We are seeking candidates that desire to be responsible for all aspects of the manufacturing process and want to be a part of a diverse operations team with daily activities that go beyond typical roles of completing PM tasks and responding to equipment downtime. The role offers opportunities to obtain in-depth processing / equipment knowledge and leadership experience in an empowered, team-driven environment.
The Operations Technician will troubleshoot, maintain, and operate process and process support equipment in support of vaccine manufacturing operations. The Technician is a self- directed employee part of a team that is responsible for providing support, direction and training in the operations area under clean room conditions. They must understand standard operating procedures (SOP's) and perform preventative maintenance (PM's) and conduct in-process testing as needed. The perform check-in, set-up/preparation of equipment, cleaning/sterilization, changeover of lines and general housekeeping as well as performing general maintenance and troubleshooting. They are expected to follows proper procedures for maintaining equipment, supplies and facilities in a sterile environment and are responsible for written documentation of activities. The successful candidate will have significant interaction with Quality, Technical Operations, Automation, Validation, and other groups as required.

Responsibilities:
  • Sets up, adjusts, repairs, and maintains all process equipment 
  • Assists Instrument Technicians and Automation Engineers as required
  • Prepares technical documentation on as needed basis
  • Participates in the establishment of new equipment and the improvement of existing process equipment.
  • Provides technical specifications and information to Quality, Manufacturing, Process-Project Engineers, and other MMD requestors
  • Maintains process equipment by developing/performing PM's, installing new equipment, documenting work using a computerized maintenance management system (SAP) and other duties as requested by the Mechanical Services Technician.
  • Performs preventative maintenance inspections and prepares inspection reports concerning operation of equipment and mechanical condition of equipment.
  • Responsible for participating in new equipment installations by interfacing with equipment vendors and recommending spare parts, selecting lubrication processes and assisting process project engineers.
  • Responsible for performing assignments in conformance with appropriate Regulatory (GMP's) and department Standard Operating Procedures which assure the quality of our products.
  • Demonstrates ability to troubleshoot mechanical and electrical components.
  • Provides training to others with-in and across functional area.
  • Sets-up and prepares equipment for ongoing operations.
  • Operates various computer controlled process support/process equipment (i.e. washer, autoclave, vial filler, lyophilizer, capping/inspect machines, etc.).
  • Follows instructions for completion of job tasks.
  • Completes written documentation of work performed.
  • Performs cleaning & Environmental Monitoring

Qualifications

Education:
  • A minimum of High School Diploma or equivalent is required for this position.
Preferred: 
  • Bachelor’s or Associates Degree in Mechanical, Computer, or Electronic Engineering Technology
Required Experience:
  • Must be willing to work 12 hour shifts, including evenings 
  • Must be willing to work a rotating 2-2-3 schedule (2 days on, 2 days off, 3 days on) which includes weekends and Holidays 
  • Must be able to successfully pass Aseptic gowning qualification. Aseptic gowning requires that all skin and hair be covered through wearing the following: Beard/moustache cover, hair net, hood and facemask, goggles, jumpsuit, gloves and boots.
  • Must be willing and able to lift 50 lbs.
  • Must be willing to be vaccinated/blood tested for titer for products manufactured within the facility if needed.
  • Must be willing to work various shifts
  • Must be able to demonstrate basic computer literacy (internet browsers, e-mail, word processing).
  • Must be able to read electrical prints, P&IDs, and shop drawings. 
  • Must be able to work from over-head platforms and ladders while wearing a safety harness. 
  • Must have excellent documentation and verbal communication skills 
  • Must possess the ability to work independently and effectively with peers, and display strong interpersonal and organizational skills.
  • Must possess at least 2-5 years of demonstrated maintenance experience with a focus on industrial, pharmaceutical, food industry, and/or laboratory equipment, troubleshooting & repair within a cGMP environment with an Asssociates degree in Engineering Technology(or equivalent), or 
  • Five (5) years of maintenance experience with a focus on industrial, pharmaceutical, food industry, and/or laboratory equipment, troubleshooting & repair within a cGMP environment.
Preferred Experience:
  • Experience in clean room or GMP/regulated manufacturing environment.
  • Ability to work with and troubleshoot computer control equipment including Programmable Logic Controllers (PLC)

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. 
If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com.   Search Firm Representatives Please Read Carefully:  Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. Visa sponsorship is not available for this position.  For more information about personal rights under Equal Employment Opportunity, visit:              EEOC Poster             EEOC GINA Supplement

Job: Production / Maintenance
Other Locations:
Employee Status: Regular
Travel: No
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck

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