Packaging Maintenance Mechanic, 2nd Shift (M-Th: 4:00PM - 2:30AM)

Knoa Pharma; Wilson (NC); On-site; USD 52,000 - 80,000; Full time

Job summary

Knoa Pharma in Wilson, NC is seeking a Packaging Maintenance Mechanic to set up, diagnose, adjust and repair oral solid dosage packaging equipment. You will perform preventive maintenance and document downtime, spare parts, and PM activities, and assist with equipment changeovers.

You will lead as SME in production, troubleshoot, ensure batch records compliance with cGMP and SOPs, and collaborate with Pharma Technology on new products.

Qualifications

• High School Diploma or equivalent.
• Minimum of five years of relevant pharmaceutical industry experience preferred.
• Strong mechanical troubleshooting and problem-solving abilities.
• Experience with packaging equipment and GMP requirements.

Responsibilities

• Set up and operate oral solid dosage packaging equipment and related line components.
• Perform preventative maintenance and document downtime, spare parts, and PMs.
• Execute packaging changeovers for product lines and formats.
• Troubleshoot mechanical issues and restore equipment to production safely.
• Ensure batch records and SOPs are followed and maintained.
• Serve as SME on equipment to maximize OEE and lead floor support.

Skills

Advanced mechanical skills

OSD packaging experience

Troubleshooting

Reading & interpreting docs

Mathematics

GMP/regulatory awareness

Education

High School Diploma or equivalent

Tools

PLC controls

Robotics

Automated packaging equipment

Job description

Join Knoa Pharma Knoa Pharma is a public health-driven pharmaceutical company dedicated to addressing the opioid crisis. Our focus is onexpanding access to lifesaving overdose reversal medicines and affordable treatments for opioid use disorder.Ownedbya not-for-profit foundation,everything we do is centeredonimproving public health,saving lives,supportingrecovery,and bringing forward medicines that make a meaningful difference.

Join Knoa Pharma Knoa Pharma is a public health-driven pharmaceutical company dedicated to addressing the opioid crisis. Our focus is onexpanding access to lifesaving overdose reversal medicines and affordable treatments for opioid use disorder.Ownedbya not-for-profit foundation,everything we do is centeredonimproving public health,saving lives,supportingrecovery,and bringing forward medicines that make a meaningful difference. Knoa Pharma has a robust generics and branded portfolio of medicines in development to address unmet medical needs, and it supports public health initiatives to address the opioid crisis. Its public health-minded purpose enables the company to expand access to lifesaving opioid overdose reversal medicines and affordable treatments for opioid use disorder – at no profit.

Position Summary

The Packaging Maintenance Mechanic is responsible for the setup, diagnosing, adjustment, and repair of all oral solid dosage, pharmaceutical packaging equipment. Maintenance Mechanics will perform routine preventative maintenance to minimize equipment downtime and ensure the product produced is of the highest quality. This role will require routine documentation pertaining to downtime, spare parts, and preventative maintenance performed. This role will also assist with equipment changeovers.

Core Responsibilities

• Ensure proper set-up and operation of oral solid dosage packaging such as but not limited to: descrambler, desiccant feeder, induction sealer, re-torquers, labelers, and outserter.
• Perform packaging equipment preventative maintenance as required.
• Ensure proper cleaning and assemble of the packaging equipment.
• Perform changeover of packaging equipment for different products including bottle size and format changes.
• Troubleshoot and correct mechanical issues as they occur.
• Ensure proper execution of batch records and standard operating procedures.
• Operate equipment as needed to ensure continuous operation of equipment.
• Function as Lead Technician (SME) in the production areas with a strong understanding of operating all equipment to achieve Overall Equipment Effectiveness (OEE).
• Interpret and carry out detailed written or verbal instructions including work orders, blueprints, drawings and sketches related to the operation, maintenance, repair, or modification of packaging equipment control and power systems while exercising judgement and discretion in the most advantageous manner.
• Assist in the installation, modification, commissioning, and qualification/validation of equipment.
• Assist Pharmaceutical Technology with new product introductions and provide feedback of processing requirements.
• Provide technical leadership and process knowledge in the training of new operations personnel.
• Contact equipment/supply vendors as needed to resolve problems and ensure limited downtime due to mechanical issues.
• May provide support in the area of small project management in the definition of requirements for and procurement of small equipment.
• Function as subject matter expert (SME) in the production areas with a strong understanding of operating all equipment to achieve Overall Equipment Effectiveness (OEE).
• Maintain strong presence on the floor to ensure that equipment problems are resolved in a timely manner with little downtime.
• Possess knowledge of working properties of common-stock materials, metallic and non-metallic.
• Disassemble equipment for repair, maintenance, modification, and/or training; reassemble the equipment, check for proper operation.
• Ensure compliance with cGMPs, OSHA, DEA, and any other regulatory guidelines and Company policies that may apply. Identify and report quality issues.
• Perform other related assignments and duties as required and assigned.
• Perform all functions according to current Good Manufacturing Practices (cGMP) and company Standard Operating Procedures (SOP
• Responsible for "Downtime", "Change Over Time", "PM's" and "Productivity" results.

Education and Experience

• High School Diploma or equivalent.
• Minimum of five years of relevant pharmaceutical industry experience preferred or equivalent combination of education, demonstrated mechanical skill.

Knowledge, Skills And Abilities

• Demonstrated advanced or expert level of mechanical knowledge, skills, and abilities supporting oral solid dose (OSD) pharmaceuticals Packaging and/or Packaging Serialization.
• Hands on maintenance, troubleshooting, repair and upgrade to packaging production equipment.
• Demonstrated ability to read and interpret documents such as safety policies, operating and maintenance instructions and procedure manuals, etc.
• Demonstrated ability to perform diverse and complex assignments in support of operations.
• Capability to perform basic/complex mathematical computations of addition, subtraction, multiplication, and division. Understanding of the Metric System of Measurement.
• Advanced knowledge of the functional/process area. The work calls for advanced comprehension of the area to solve unusual as well as common work problems, to be able to advise on technical matters, and to serve as a resource on the subject for others in the organization.

Highly Preferred Skills/Qualifications

• Certification/Associate’s/Bachelor’s degree in Manufacturing, Engineering, or Technology related fields
• Operational Excellence; Six Sigma Green Belt certified
• Advanced Computerized Manufacturing
• Controls (Programmable Logic Controls); Motors & Controls; Robotics
• Maintenance, Installation, and Repair
• Diagrams/Schematics
• Root cause analysis/problem solving tools and techniques

Physical and Environmental Requirements

• Occasionally, transport materials using manual, and power assisted vehicles including manually pushing and pulling drums, totes, boxes, and pallets
• Frequently push, lift and maneuver boxes and materials weighing up to 50 pounds.

Supervisory Requirements (if applicable)

• This role does not have direct supervisory or managerial responsibility.

Additional Information

This job description is not intended to be an all‑inclusive list of duties and responsibilities and may be modified as business needs require.

We are an Equal Opportunity Employer. Qualified applicants will receive consideration without regard to: actual or perceived race, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), national origin, ancestry, citizenship status, religion, color, age, creed, sexual orientation, marital status, gender identity or gender expression (including transgender status), protected medical condition as defined by applicable state or local law, genetic information, physical or mental disability, veteran status and military service, or any other characteristic protected by local, state, or federal laws and ordinance.

• EEOC Know Your Rights
• USERRA Rights
• Family and Medical Leave Act (FMLA)
• Employee Polygraph Protection Act (EPPA)
• E-Verify (English and Spanish)
• Right to Work (English and Spanish)

We strive to make our Career opportunities website accessible to all users. If you need an accommodation to participate in the application or hiring process, please email the Knoa Pharma LLC Talent Acquisition team at [e-mail]. This email is not for general employment inquiries or vendors; rather it is strictly for applicants who require assistance.

The Company does not seek or accept unsolicited resumes or CVs from recruitment agencies. We are not responsible for any fees, commission, or any type of payment related to unsolicited resumes or CVs except as required in a written agreement between the Company and the recruitment agency or party requesting payment of a fee.

Under certain state law, we may be required to provide a reasonable estimate of the salary range for the jobs covered by this description. Actual salary determinations will take into account factors such as work location, prior education or training and experience, job related knowledge, and demonstrated skills aligned with the Company’s internal leveling guidelines and benchmarks. Resumes may be considered in the order they are received.