Quality Engineer: Validation

Overview

Description

At American Packaging Corporation (APC), you’ll find the packaging career you’ve been looking for. With competitive salaries, excellent benefits, 401(k) plans, and tuition reimbursement programs, we nurture our employees while advancing and promoting diversity and inclusion. As the leading flexible packaging converter in North America for over a century, APC’s longstanding success is fueled from the inside out. We’re constantly seeking to improve our internal operations and were named a “Best of the Best” in the Best workplaces in the America’s awards for 12 years in a row.

It’s how and why we engage the best and brightest talent to continue propelling our shared success into the future.

LOCATION: Rochester, NY

SUMMARY: THIS POSITION WILL PRIMARILY FOCUS ON THE VALIDATION TASKS OF THE JOB DESCRIPTION

Apply project management and technical expertise to successfully deliver Validation program goals and outcomes while interacting with customers and meeting their expectations.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Validation

• Manage the scope, schedule, and reporting of Validation program activities for individual products and/or customers; ensure status, risks, and open issues are tracked and that all stakeholders (Management, internal/external clients, Business Managers/Project Managers, and regulatory agencies) are informed in a timely manner.
• Write and execute IQ/OQ/PQ validation protocols, and manage the associated deviation process.
• Management and leadership of the change control, calibration, and gage R&R processes.
• Provide hands-on support to manufacturing areas as required to assist with problem-solving and long-term changes that lead to product/process improvements related to process failures. Collect and analyze data to make data-driven recommendations/decisions.
• Participate in process failure investigations.
• Maintain up-to-date knowledge of validation requirements, practices, and procedures, and instruct other site members participating in validation studies.
• Support risk analysis activities, including design and process FMEA.
• Facilitate team meetings as needed on in-depth process and product analysis, risk assessments, decision-making, and other evaluations related to the Validation program.
• Assist in internal and 3rd party audits.
• Provide backup for Quality Supervisors and Quality technicians.
• Drive continuous improvement opportunities utilizing lean six sigma and the seven basic quality tools, to benefit the success of APC, including profit improvement plans, long and short-term strategic objectives, helping establish problem-solving teams and methods, and recommending capital projects that improve Safety, Productivity, and Quality.
• Write and improve manuals, standards, and procedures as needed.
• Use of statistical software and techniques for analysis of data, including Process Capability (Cpk, Ppk), Statistical Process Control (SPC), and Design of Experiments (DOE)
• Other duties as assigned.

REQUIREMENTS: To perform this job successfully, an individual must be able to perform 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 the essential functions.

EDUCATION and/or EXPERIENCE

Bachelor's degree in science, mathematics, or engineering from a four-year college or university, and two years related experience and/or training; or equivalent combination of education and experience. ASQ certification is preferred.

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 speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors.

MATHEMATICAL SKILLS

Ability to apply advanced mathematical concepts. Ability to utilize descriptive statistics (average,…