Validation Engineer I

Sharp Corporation; Allentown (Lehigh County); On-site; USD 75,000 - 110,000; Full time

Job summary

Sharp Packaging Services seeks a Validation Specialist to lead execution of validation activities for equipment, processes, and facilities, aligned with cGMP and guided by the Validation Manager. The role may cover multiple sites including Macungie, Conshohocken or Allentown, with the work located at one designated site.

You will write and review IQ/OQ/PQ protocols, support audits, and coordinate with Internal Operations, Sales, Engineering, and QA to ensure regulatory compliance and customer

Qualifications

• Bachelor’s degree in technical discipline (BS/BA) preferred with three to five years related experience.
• Independent certification in advanced quality skills (ASQ, CQE, Six Sigma) preferred.
• Knowledge of FDA regulations, cGMPs, and validation guidance documents.
• Ability to structure validation protocols per a planned approach.
• Familiarity with ANSI Z1.4 sampling plans; strong written communication.
• Ability to plan, schedule, and multi-task validation activities.

Responsibilities

• Develop and write ES/IQ/OQ/PQ protocols for equipment and systems per cGMP.
• Support validation program design and execution.
• Participate in URS, FAT, SAT and engineering studies as requested.
• Coordinate validation activities across Sharp facilities (Macungie, Conshohocken, Allentown).
• Review executed protocols and write summary reports.
• Support customer and regulatory audits related to validation.

Skills

ASQ CQE Six Sigma

Validation principles

Engineering principles

Quality sampling plans

Written communication

Oral communication

Project planning & multitasking

Independent work ethic

Education

Bachelor's degree in technical discipline

Job description

SUMMARY

Responsible for validation activities at respective Sharp facility. Responsibilities include execution of all validation activities related to equipment, process and facilities qualifications in the direction of the Validation Manager. The scope of work may extend into temperature mapping activities. Validation activities will be performed at all facilities within the guidelines of current good manufacturing practices. Responsible for ongoing contact with Internal Operations, Sales, Engineering, Quality Assurance, and customers regarding validation activities and scheduling. The scope of the position includes Macungie, Conshohocken or Allentown. The position will be located at one designated site. The duties of this position directly impact on company compliance with regulatory requirements and customer satisfaction.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Support the validation program by contributing to development of validation approach, design and execution.
• Write ES/IQ/OQ/PQ protocols for appropriate equipment and systems within the guidelines of cGMP.
• Participate in URS, FAT, SAT and Engineering Studies when requested.
• Write PV protocols specific to customer needs and per Sharp requirements.
• Responsible for communicating validation approach and requirements with customers.
• Execute validation protocols.
• Review executed protocols and write summary reports.
• Provide support for customer audits and external regulatory audits specific to validation activity at all Sharp facilities at the direction of the Validation Manager.
• Responsible for coordinating the execution of validation activities at designated Sharp facility including but not limited to packaging, HVAC, equipment qualification, packaging processes and facilities and utilities.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Independent certification of advanced quality skills and practices (i.e. ASQ, CQE, Six Sigma, etc.) is required
• Knowledge of current validation principles and industry practices, including FDA regulations, cGMPs, and validation guidance documents is required
• Knowledge of basic engineering principles and practices, equipment automation controls, etc. is required
• Ability to structure validation protocols in conformance with a planned validation approach is required
• Familiarity with quality and attribute sampling plans (e.g. ANSI ZI.4) is required
• Excellent written communication skills are required
• Ability to plan and schedule validation activities and to multi-task is required
• The position requires the ability to work independently and to commit to meet project deadlines
• Good oral communication, organizational and planning skills are required
• Familiarity with quality engineering practices in packaging operations is desired
• Relevant ASQ certification is desired

SUPERVISORY RESPONSIBILITIES

• Coordinate the work of Validation Technicians
• Provide directions to Tech Ops personnel during an ES, IOQ, or PQ

EDUCATION and/or EXPERIENCE

Bachelor’s degree in technical discipline (BS/BA) from a four‑year college or university preferred with three to five years related experience and or training; or equivalent combination of education and experience.

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 accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to handle equipment, write, and to speak and hear. The employee frequently is required to sit. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus. Travel to local sites is required in all weather conditions. Travel to customers and to equipment suppliers on an as needed basis. International travel may be required for FATs. Passport required.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is normally required to sit at a desk and regularly go onto the shop floor and to work near packaging equipment. The working environment is clean and not normally subject to hazardous environment or conditions. Approximately 5 percent of auto travel between sites. Travel to customers and to equipment suppliers on an as needed basis. International travel may be required for FATs. Passport required.

DISCLAIMER

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

Sharp Packaging Services works across the world to create unique commercial and clinical packaging solutions for the pharmaceutical and biotechnology industry. We are made up of two dynamic international divisions, Sharp Packaging Solutions and Sharp Clinical Services. Together our 1,600-strong team works from state-of-the-art facilities in the United States, United Kingdom, Belgium and the Netherlands. We’ve built an exceptional global reputation for the design, serialisation and production of innovative, cost-effective compliance packaging for even the most complex products. Our extensive range includes blister packs, bottles, pouches and stick packs, but our expertise goes far beyond, enabling us to support your product through every stage of design, development, manufacture and delivery. Our clinical services division is one of the world’s leading providers of innovative clinical supply chain services, with a talented and highly experienced team that can handle every aspect of your supply chain. Our work spans everything from drug development and manufacturing to clinical supplies packaging, labelling, distribution, Qualified Person auditing and comparator sourcing.