Packaging Maintenance Mechanic, 1st Shift (Mon. - Thurs; 6:00am - 4:30pm)

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.

Job 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.

Primary 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 Requirements

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

Necessary 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

Supervisory Responsibilities (if Applicable)

The Packaging Maintenance Mechanic has no direct reports.

Physical and Environmental

• 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.
• Ability to work standard schedule of 10.5 hours a day, Monday - Thursday and overtime as needed.

Additional Information

Relocation is not offered for this position.

The Company does not sponsor or facilitate any U.S. work or training authorization for this position. All applicants must have unrestricted and independent authorization to work or participate in an internship or training program at the Company.

Minimum required education, experience, knowledge, skills and abilities for this position are included in the posting. The position will be filled at the level commensurate with the successful candidate's education, experience, knowledge, skills, and abilities.

The job description is not an exhaustive list of all functions that the employee may be required to perform, and the employee may be required to perform additional functions. Additionally, the company may revise the job description at any time.

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.

For more information about your rights under Equal Employment Opportunity, visit:

• 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 View email address on click.appcast.io . 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.