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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 is essential for maintaining and enhancing the equipment, systems, and processes to comply with industry regulations and standards.
The Engineer will oversee, manage, coordinate, and execute engineering initiatives at the designated Sharp facility from initial concept through to final implementation.
Continuous support will be provided during production start-up, technology transfer, and ongoing assistance post-qualification and initiation. This role necessitates effective communication across departments, including Central Engineering, Operations, Finance, Quality Control, Project Management, and Sales.The Engineer will hold functional authority for the planning, organization, control, integration, and completion of 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 maintain all manufacturing machinery, utilities, and automated systems.
Develop and implement preventive maintenance strategies to reduce downtime, enhance performance, and ensure safe operations.Issue Resolution:
Leverage technical expertise to identify, diagnose, and swiftly resolve equipment or process-related challenges. Work alongside cross-functional teams to devise effective solutions, ensuring minimal disruption to production workflows.
Process Enhancement:
Identify and pursue opportunities for optimizing processes, reducing costs, and improving energy efficiency within the facility. Propose and implement innovative strategies to boost productivity, quality, and safety while adhering to regulatory requirements.
Regulatory Compliance and Record Keeping:
Maintain precise documentation of equipment maintenance, repairs, and incidents. Ensure adherence to all relevant regulatory guidelines, including FDA, cGMP, and other applicable standards. Participate in audits and inspections, promptly addressing any findings.
Capital Project Management:
Collaborate with Central Engineering and Electrical Controls teams to plan and execute capital projects, including equipment installations, upgrades, and modifications.
Provide technical guidance 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 to achieve these objectives.
Coordinate with the Project Team Manager and Mechanical & Electrical Services Group to ensure technical project goals align with the overall project strategy.
Tooling Development:
Work with existing equipment vendors to obtain tooling and service estimates. Responsible for project proposal drawings, reviewing artwork, material layouts, and web layouts. Capable of reverse engineering parts and assemblies. Maintain and update Engineering Turn Over Packages and databases such as Sample Order, Tool Set Number, and Tooling Number.
Possess a comprehensive understanding of all equipment and processes.
Enhance knowledge through technical data interpretation, 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 Development:
Stay informed about industry trends, emerging technologies, and best practices in pharmaceutical manufacturing. Author and update equipment work instructions and preventive maintenance schedules. Mentor and train junior technicians and operators on equipment operations, maintenance, and safety protocols.
SUPERVISORY ROLE
This position does not include supervisory responsibilities but will provide technical support to Mechanics and Electricians during construction, start-up, and ongoing production activities for machinery.
QUALIFICATIONS:
To successfully perform this role, an individual must be capable of fulfilling each essential duty satisfactorily. The requirements listed below represent the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
EDUCATION and 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, project planning, and coordination is essential, along with strong written, verbal communication, and presentation skills.
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 pharmaceuticals, and familiarity with FDA/cGMP compliance environments.
Excellent understanding of regulatory requirements (FDA, cGMP, etc.) and quality systems. Proficiency in AutoCAD is required, and experience with SolidWorks is a plus.LANGUAGE SKILLS:
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to inquiries or complaints from customers, regulatory agencies, or business community members. Ability to write articles and speeches 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 perform mathematical operations related to frequency distribution, 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 manage 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.
