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Pharmaceutical Packaging Systems Engineer
2 months ago
The Packaging Equipment Engineer plays a vital role in the seamless operation of our pharmaceutical production facility.
This position demands creative problem-solving skills and will aid in the maintenance and enhancement of the plant's machinery, systems, and workflows to ensure adherence to industry regulations and standards.
The engineer will oversee, coordinate, and execute engineering initiatives at the designated Sharp facility from initial concept through to completion.
Ongoing support will extend through production initiation, technology transfer, and continued assistance post-qualification and start-up. This role necessitates collaboration with various departments including Central Engineering, Operations, Finance, Quality Control, Project Management, and Sales.The engineer will have the authority to plan, organize, control, integrate, and finalize engineering projects within their designated area by performing the following responsibilities.
KEY RESPONSIBILITIES include the following.Equipment Oversight:
Collaborate with the Mechanical Electrical Services Group to monitor and sustain all manufacturing machinery, including production equipment, utilities, and automated systems.
Develop and execute preventive maintenance strategies to reduce downtime, enhance performance, and ensure safe operations.Diagnostics and Resolution:
Leverage technical expertise to swiftly identify, analyze, and rectify equipment or process-related challenges. Work with cross-functional teams to implement effective solutions, minimizing production disruptions.
Process Enhancement:
Recognize opportunities for process improvement, cost efficiency, and energy conservation within the facility. Propose and enact innovative strategies to boost productivity, quality, and safety while complying with regulatory mandates.
Regulatory Compliance and Record Keeping:
Maintain precise documentation of equipment maintenance, repairs, and incidents. Ensure adherence to all relevant regulatory standards, including FDA, cGMP, and other applicable guidelines. Participate in audits and inspections, promptly addressing any findings.
Capital Project Management:
Partner with Central Engineering and Electrical Controls teams to strategize and implement capital projects, including equipment installations, upgrades, and modifications.
Provide technical insight during the design, procurement, installation, and commissioning phases. Project management responsibilities include developing and drafting specific project documentation, such as User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT) as necessary.Integrate all project aspects, including the design formulation for product handling, filling processes, and the machinery required for execution.
Coordinate with the Project Team Manager and Mechanical & Electrical Services Group to ensure technical project objectives align with the overall project strategy.
Tooling Development:
Work with existing equipment suppliers to acquire tooling and service estimates. Responsible for project proposal drawings, reviewing artwork layouts, material layouts, and web layouts. Capable of reverse engineering components and assemblies. Maintain and update Engineering Turn Over Packages and databases such as Sample Order, Tool Set Number, and Tooling Number.
Must possess a comprehensive understanding of all equipment and processes.
Enhance knowledge through individual technical data, interpretation of mechanical functions, and in-depth discussions with production mechanics, quality personnel, equipment operators, and manufacturers' representatives.
Collaborate with the Mechanical and Electrical Services Group to design tooling and machine components based on layouts and package proposal drawings.
Training and Knowledge Sharing:
Stay informed about industry trends, emerging technologies, and best practices related to pharmaceutical manufacturing. Author and revise equipment work instructions and preventive maintenance schedules. Mentor and train junior technicians and operators on equipment operation, maintenance, and safety protocols.
SUPERVISORY ROLE
This position does not have supervisory responsibilities but will provide technical support to Mechanics and Electricians during the construction, start-up, and ongoing production activities for machinery.
QUALIFICATIONS:
To successfully fulfill this role, an individual must be capable of performing each essential duty satisfactorily. The requirements listed below represent the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
EDUCATION and/or EXPERIENCE
A Bachelor's degree in Mechanical, Chemical, or Electrical Engineering (or a related field) with a minimum of 3 to 5 years of relevant experience and/or training; or an equivalent combination of education and experience.
Direct experience in troubleshooting manufacturing lines is essential; the ability to plan and coordinate projects; strong written, verbal communication, and presentation skills are required.
Proven experience in project management and the ability to manage multiple projects concurrently.Preferred qualifications include a working knowledge of applied manufacturing engineering principles; industry experience in food or pharmaceutical sectors and familiarity with FDA/cGMP compliance environments.
A solid understanding of regulatory requirements (FDA, cGMP, etc.) and quality systems is crucial. Proficiency in AutoCAD is required, and experience with SolidWorks is advantageous.LANGUAGE SKILLS:
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write articles and documents for publication that conform to prescribed style and format.
MATHEMATICAL SKILLS:
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
Ability to apply mathematical operations to tasks such as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
REASONING ABILITY:
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret a wide variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
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.
While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel.
The employee frequently is required to stand, sit, and talk or hear.The employee is occasionally required to walk; reach with hands and arms; climb or balance; and stoop, kneel, crouch, or crawl.
The employee must occasionally lift and/or move up to 25 pounds.Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
