Associate Technician, Maintenance

Job Description

Associate Technician, Maintenance 

• Job Description In Primary Posting Language (Include Requirements For Education, Experience And Skills)

Associate Technician, Maintenance (1st Shift)

The Bio Process Maintenance Associate Technician will be a member of the Maintenance & Operations team within the Vaccines integrated process team for a start-up vaccine manufacturing facility in Wilson, NC.  Under the direction of a Operations/Maintenance Coach, provide maintenance support to Pharmaceutical process equipment. Takes appropriate action to correct operational maintenance problems. Responsible for carrying out the Manufacturing Division Divisional and site mission by assuring the quality of products and services are of the highest quality, optimal cost, and delivered on schedule. Responsible for continuing improvement in all aspects of the operation.

In addition to the day to day maintenance activities, the individual is accountable for providing shop floor operations support to aseptic manufacturing within the vaccine manufacturing facility. Tasks will include aseptic primary filling, inspection, packaging, CIP/SIP and room and equipment disinfection.  Must be able to function in a team-based culture and operate in an empowered environment. Identifies and demonstrates a working knowledge of customers, suppliers and their requirements. Seeks ideas and information on how to improve customer service involving internal and external customers. Applies knowledge of the overall supply chain to efficiently complete work tasks. Applies knowledge of key business processes in their functional areas to perform daily work tasks. Adheres to the highest level of data integrity in all activities.

Delivery

• Checks set-up, changes over, and adjusts production/process equipment according to current SOP’s and Competency Based Training Modules. Performs experimental set-ups and runs trials at the direction of the process/project/reliability engineer as required.
• Determines proper settings and clearances, installs parts and adjusts for given machine requirements at the time of initial set-up and during operations as outlined in set-up specifications or as required.
• Execute corrective and preventative maintenance on manufacturing equipment
• Test runs equipment to determine coordinated timing, alignment, machine height, and other relatively basic fixed adjustments.
• Disassembles and inspects parts and equipment to determine the cause of improper operations. Makes a repair through the use of replacement parts and reassembles equipment with new or repaired parts.
• Cleans and lubricates machines periodically and performs other maintenance work required to assure the efficient operation of all equipment.
• Performs minor and assists with major overhauls to process equipment by disassembling, repairing, and reassembling equipment to proper operation condition. This includes but not limited to disassembling manufacturing/Filling/Packaging machines & plant engineering process equipment.
• Identifies the root cause of equipment malfunctions occurring while equipment is in operation and whenever possible repairs and adjusts the equipment in a manner which will result in the minimum production delay.
• Assist with the the calibrate of industrial control, measurement, and recording equipment. Prepares accurate GMP acceptable documentation recording measured information for files retention.
• Uses technical information, reads and interprets drawings, diagrams, and schematics, and carries out maintenance troubleshooting and repairs.
• Set up and perform aseptic vaccine manufacturing to include primary filling, inspection, packaging, CIP/SIP, and additional equipment within qualified parameters
• Identify potential equipment problems and partner with Vaccines Maintenance Technicians to ensure appropriate resolution. Demonstrate ability to troubleshoot process, electronic systems, and equipment for routine and basic problems.
• Perform other duties as requested by the Operations coach
• Demonstrates the ability to troubleshoot equipment.

Compliance

• Accountable for performing work in a safe manner, following identified safety procedures (hazardous work permitting, LOTO, HECPs), and using applicable safety equipment / personnel protective equipment (PPE)
• Execute maintenance and operations functions in accordance with current Good Manufacturing Practices (cGMPs) and standard operating procedures (SOPs)
• Complete documentation in EAM, electronic batch records, electronic logs, and other systems in accordance with site procedure
• Maintain good housekeeping and 5S in assigned work area
• Adhere to the highest level of data integrity while performing duties
• Identify potential quality or safety issues.  Escalate as per IPT management processes and assist in the investigation, root cause determination, and CAPA implementation.
• Must be able to participate in and/or provide direct specialized training to any Manufacturing Division employee requiring it.

Cost

• Ensure that startup activities for area of assignment are executed such that deliverables and timelines are met
• Closely monitor team / process performance and improve reliability through problem solving and continuous improvement
• Set up, troubleshoot and operate equipment in alignment with established training and procedures to ensure reliable operation with minimal delays or discards
• Identify and help implement continuous improvement and productivity enhancements within the IPT

Team

• Partner with Technicians, Operations personnel and cross-functional groups for assigned area
• Demonstrate a high degree of maturity and personal integrity.  Strictly adhere to all site policies on personal conduct and attendance. 
• Train, develop, and mentor other team members to share experience and best practices
• Pursue knowledge and skills in assigned area from an operations perspective and share that information readily with team
• Maintain a culture of continuous improvement / MPS focused on standard work, making problems visible, minimizing waste, reducing process variability, and problem solving
• Routinely demonstrates leadership and conflict-resolution ability.  Demonstrates a willingness to provide and receive constructive feedback in 360° performance review.
• Responsible for performing work in a safe manner following identified safety procedures and using applicable safety equipment.

Reporting Relationships:

• Solid line report to: Manager, Maintenance & Operations        
• Dotted line report to: N/A
• Position(s) reporting to this position: N/A (individual contributor)

Work Schedule:

• 8-hours 1st Shift (06:00AM - 02:30PM)

Minimum Education Requirement:

• High School diploma or equivalent 

Required Experience and Skills:

• One or more years of experience in a GMP manufacturing facility including maintenance experience (aseptic GMP environment strongly preferred). 
• Demonstrated ability to work independently and as team member
• Demonstrated interpersonal skills with ability to influence and assist others through a culture of inclusion, feedback, and empowerment
• Ability to gown and work in an aseptic environment
• Demonstrated ability to work with computerized and automated systems.
• Willing to work irregular hours to support multi-shift operation on an as needed basis

Preferred Education, Experience and Skills:

• Associates degree in Business, Science, or Technology-based field and/or bio-pharma focused certificates, such as Bioworks, preferred.
• Experience with maintenance troubleshooting, Preventative and Corrective Work Orders, aseptic filling equipment, visual inspection systems, CIP/SIP systems, packaging equipment and similar aseptic formulation and filling operations
• Experience operating, maintaining, troubleshooting, and/or repairing industrial equipment
• Experience working in a regulated environment (FDA, etc.) and basic knowledge of cGMPs as they apply to the vaccine/pharmaceutical industry
• Experience in Continuous Improvement, Lean Manufacturing, Problem Solving, and/or Right First-Time methodologies
• EAM / SAP / MES / electronic logbook basic knowledge from a production execution perspective
• Demonstrated leadership ability, peer training experience, and/or productivity improvement activities
• Demonstrated ability and drive to work autonomously and help organize priorities and work with other team members
• Outstanding communication skills both within direct team and across multiple shifts to ensure success of overall team
• Ability to support technical writing of documents such as standard operating procedures (SOPs)
• Job Description In Secondary Posting Language(s) (Include Requirements For Education, Experience And Skills)
• Job Families for Job Profiles

#MSJR

The salary range for this role is: $47,600 - $75,100

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. 

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. 

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.