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. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The Vaccine Manufacturing Facility Operations Technician role is a multi-faceted position. The successful candidate will use their maintenance expertise to ensure that the equipment is running at optimal levels at all times. The Operation's Technician will be responsible for all aspects of product manufacturing and equipment maintenance to include preventive maintenance, troubleshooting and repair - this will involve true ownership. 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 desiring 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 process / 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 Merck Durham facility boasts an empowered culture and as such, the Technician is a self- directed employee part of a team that is responsible for providing support, direction and training in the operations area of Lyophilization in clean room conditions. Develops standard operating procedures (SOP's) and preventative maintenance (PM's) plans as requested and conducts in-process testing as needed. Performs check-in, set-up/preparation of equipment, cleaning/sterilization, changeover of lines and general housekeeping and performs general maintenance and troubleshooting. Follows proper procedures for maintaining equipment, supplies and facilities in a sterile environment and is responsible for written documentation of activities. Actively supports, participates and embraces an empowered team culture including significant interaction with Quality, Technical Operations, Engineering and other groups as required.
• 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.
• Demonstrated ability to troubleshoot mechanical and electrical components.
• Perform general troubleshooting and maintenance of equipment while maintaining production schedule.
• Provide training to others.
• Set-up and prepare equipment for ongoing operations.
• Operate various computer controlled process support/process equipment (i.e. washer, autoclave, filling line, lyophilizer, cap/inspect machines, etc.).
• Follow instructions for completion of job tasks.
• Complete written documentation of work performed.
• Cleaning & Environmental Monitoring
Education Minimum Requirement:
Required: A minimum of High School Diploma or equivalent is required for this position.
Preferred: Bachelor's or Associates Degree in Mechanical/Electronic Engineering
Required Experience and Skills:
Must be willing to work 12 hour shift
Must be willing to work a rotating 2-2-3 schedule (2 days on, 2 days off, 3 days on) which will include Holidays and weekends
Basic computer fluency (internet browsers, e-mail, word processing).
Must be able to read electrical prints, P&IDs, and shop drawings.
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.
At least 4 years of maintenance experience with a focus on industrial, pharmaceutical, food industry, and/or laboratory equipment, troubleshooting & repair within a cGMP environment with an associate degree in engineering (or equivalent) OR 7 years maintenance experience with a focus on industrial, pharmaceutical, food industry, and/or laboratory equipment, troubleshooting & repair within an cGMP environment
Preferred Experience and Skills:
Experience in clean room or GMP/regulated manufacturing environment.
Ability to work with and troubleshoot computer control equipment including Programmable Logic Controllers (PLC)
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org.
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.
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