SUMMARY:

A Pharmaceutical Manufacturing Company is looking for the talents of a Maintenance Engineer. The Maintenance Engineer will support activities of the pharmaceutical production and ensure compliance with policies and regulations. Perform setup, maintenance and operation of aseptic and non-aseptic production equipment along with general facility repair and maintenance. Research and evaluate technology and design related to existing and new processes with the aim of optimization of performance throughout the product life cycle.

ESSENTIAL DUTIES AND RESPONSIBILITIES

include the following. Other duties may be assigned. Studies blueprints, sketches, drawings, specifications and manual to understand machine setup, operation and troubleshooting. Support and operate production process equipment. Install the appropriate change parts to setup pharmaceutical process equipment in the aseptic and non-aseptic area such as labeling machine, cartoner, casepacker, and etc. Troubleshoot manufacturing problem of production process equipment including the installation of replacement parts or design tooling to ensure continued functionality and/or improve performance. Follow procedures to perform general preventative maintenance of production process equipment. Coordinate with Maintenance Department office to ensure timely preventative maintenance or request appropriate corrective maintenance on applicable equipment. Participate in equipment commissioning, qualification (IQ/OQ/PQ), and validation efforts. Coordinate with Metrology Department to ensure timely calibration of all instruments related to the packaging/Filling machine operations. Support installation of new equipment and upgrades to existing systems. Order and maintain appropriate spare part level for production process equipment. Support the preparation of the equipment and components for production schedule. Support relevant Engineering activities for current or developmental manufacturing processes and equipment Conduct investigations relating to manufacturing non-conformances and implement effective corrective and preventative actions.

QUALIFICATION REQUIREMENTS

Mechanical aptitude. Ability to understand, follow and audit complex written procedures. Good critical thinking ability High attention to details and awareness of surroundings. Methodical and meticulous Awareness of cGMP and SOPS. Ability to use small hand tools such as: Screwdrivers, nut drivers, wrenches and allen wrenches Ability to use common mechanical and electrical tools. EDUCATION and/or

EXPERIENCE

Bachelor's degree (B.S.) from four-year college or university in Mechanical or Electrical engineering or other relevant scientific field. At least 6 months of experience in Pharmaceutical manufacturing or equivalent and relevant field desired. Clear understanding of mechanical system, process control, pharmaceutical manufacturing processes and cGMP also desired.

PREFERRED QUALIFICATIONS

Certification in maintenance or reliability engineering ( e.g., CMRP). Experience with Lean Manufacturing or Six Sigma methodologies. Knowledge of environmental and safety regulations relevant to pharmaceutical manufacturing. Master degree in Mechanical/Electrical preferred

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential work functions. While performing the duties of this job, the employee is regularly required to stand, sit, walk and talk or hear. The employee frequently is required to use hands, fingers, handle, or feel objects, tools or controls and reach with hands and arms. The employee is required to climb or balance; and stoop, kneel or crouch. The employee is frequently required to work on their feet for long period of time. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds. The employee must be able to climb to the top of building/ equipment for verification purposes. May require overtime or adjustable hours when necessary to accommodate the schedule or unforeseen circumstances. Sunshine Act Amphastar reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Amphastar to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Amphastar intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Amphastar that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. EEO & Employment Eligibility Amphastar is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Amphastar also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Amphastar is an E-Verify employer. Amphastar is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Job Type:

Full-time Pay:

$36.00 - $40.00 per hour

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Health savings account Life insurance Paid time off Referral program Vision insurance

Education:

Bachelor's (Preferred)

Experience:

Pharmaceutical Manufacturing:

1 year (Preferred)

Work Location:

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Maintenance Engineer