Senior Validation Engineer

Sharp Services, LLC; Macungie (Lehigh County); On-site; USD 90,000 - 130,000; Full time

Job summary

Sharp Services, LLC is seeking a Validation Specialist to independently plan, coordinate, and execute validation activities across equipment, processes, facilities, and computer systems. The role involves collaboration with Operations, Sales, Engineering, Quality Assurance, and customers to schedule and perform validation per cGMP guidelines.

Location includes Conshohocken and Allentown facilities, with duties at designated sites.

Qualifications

• Bachelor’s degree in technical discipline (BS/BA) from a four‑year college or university preferred with six to ten years related experience and/or training.
• Independent certification of advanced quality skills and practices (i.e. ASQ, CQE, Six Sigma, etc.) is required.
• Board knowledge of current validation principles and industry practices, including FDA regulations, cGMPs, and validation guidance documents is required.

Responsibilities

• Support the Validation Manager in developing validation approach, design and execution.
• Represent the Validation function in the review and approval of Change Controls involving equipment and processes.
• Complete the Validation review and approval of Master production Records.
• Write IQ/OQ/PQ protocols for appropriate equipment and systems within the guidelines of cGMP.
• Supervise the execution of validation activities at designated Sharp facility including but not limited to packaging, cleaning, HVAC and computer system.
• Participate in customer audits specific to validation activity at all Sharp facilities as directed by the Validation Manager.

Skills

Independent planning

Scheduling

Problem solving

Documentation writing

Education

BS/BA in technical discipline

ASQ CQE Six Sigma certs

Tools

Pilgrim SmartSolve

Lotus Notes

Microsoft Office

Job description

SUMMARY

Responsible for independent planning, coordination and execution of validation activities either on-site (within Sharp facility) or off‑site (supplier or client facility). Responsibilities include execution of all validation activities related to equipment, process, facilities and computer systems as required. Validation activities will be performed at all facilities within the guidelines of current good manufacturing practices. Responsible for ongoing contact with Operations, Sales, Engineering, Quality Assurance, and customers regarding validation activities and scheduling.

Scope of the position includes both Conshohocken and Allentown facilities. The position will be located at one designated site.

The duties of this position directly impact on company compliance to regulatory requirements and customer satisfaction.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The following is a list of minimum responsibilities related to this position. Other duties may be assigned.

Support the Validation Manager in the development of validation approach, design and execution.

Represent the Validation function in the review and approval of Change Controls involving equipment and processes.

Complete the Validation review and approval of Sharp Master production Records.

Develop validation requirements for projects related to new equipment, processes, facilities and products.

Write IQ/OQ/PQ protocols for appropriate equipment and systems within the guidelines of cGMP.

Responsible for supervising the execution of validation activities at designated Sharp facility including but not limited to packaging, cleaning, HVAC and computer system.

Write PV protocols specific to customer needs.

Responsible for communicating validation approach and requirements with customers.

Monitor or execute validation protocols assigned.

Review executed protocols and write final reports.

Responsible for supervising the execution of validation activities at designated Sharp facility including but not limited to packaging, cleaning, HVAC and computer system.

Participate in customer audits specific to validation activity at all Sharp facilities at the direction of the Validation Manager.

Participate in external regulatory audits specific to validation activities at the direction of the Validation Manager

SUPERVISORY RESPONSIBILITIES:

Moderate including scheduling, daily checks of project status, and supporting Validation Manager as requested. Oversee project team members and support Validation staff in the development and execution of protocols and reports. Review executed protocols for conformance with requirements and good validation practices.

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.

EDUCATION and/or EXPERIENCE:

Bachelor’s degree in technical discipline (BS/BA) from a four‑year college or university preferred with six to ten years related experience and or training; or equivalent combination of education and experience. Independent certification of advanced quality skills and practices (i.e. ASQ, CQE, Six Sigma, etc.) is required

• Board knowledge of current validation principles and industry practices, including FDA regulations, cGMPs, and validation guidance documents is required.
• Familiarity with quality engineering practices in manufacturing operations is required.
• Knowledge of basic engineering principles and practices, equipment automation controls, etc. is required.
• Ability to independently plan and schedule validation activities is required.
• Ability to multi-task is required.
• Ability to commit to and meet project deadlines is required.
• Ability to structure validation protocols in conformance with a planned validation approach is required.
• Excellent written communication skills are required.
• Good oral communication, organizational and planning skills are required.

MATHEMATICAL SKILLS:

Basic math skills (addition, subtraction, multiplication and division) are required. Ability to apply complex mathematical operations, scientific notation and conversion factors, statistics, standard deviation, distribution analysis, capability analysis, Design of Experiments and sampling theory.

LANGUAGE SKILLS:

Ability to read, analyze, and interpret common scientific data and technical documents is required. Ability to read and interpret engineering documents and drawings is required. Ability to respond professionally to common inquiries or complaints from customers regarding validation issues is required.

Ability to effectively present information to the following groups:

• Internal: daily contact with Quality Department, Sales, Engineering and Operations Department employees for information exchange, collaboration, problem solving, direction regarding customer validation issues. Frequent contact with Account Executives and/or Project Managers for information exchange and direction regarding customer validation issues.
• External: Frequent contact with customer representatives planning new product introductions, and problem-solving validation issues. Occasional contact with client auditors and regulatory representatives (e.g. FDA, DEA) for inspections, questions and problem resolution related to validation matters as required by the Validation Manger.

WRITTEN SKILLS:

Ability to compile technically sound and grammatically correct validation protocols and summary reports is required. Ability to produce clear and concise documentation within forms and/or memos to file in conformance with basic Good Documentation Practices is required. Technical writing skills are required.

REASONING ABILITY:

Ongoing contact with internal Operations, Sales, Engineering and Quality Department employees, Customer QA representatives, occasional contact with regulatory personnel concerning compliance with customer requirements as well as cGMP’s concerning validation issues. Customer agreements and regulatory guidelines are available to assist; however frequent review and reasonable interpretation are necessary to keep current. Good organizational skills are necessary. Good mental skills for analysis and problem solving are needed. Need an ability to negotiate to reach a common solution meeting everyone’s needs.

COMPUTER SKILLS:

Must be proficient in Microsoft Office Suite. Windows O/S Pilgrim SmartSolve and Lotus Notes.

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 or write and to speak and hear. The employee frequently is required to sit. The employee is regularly required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, and 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. 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 periodically go onto the shop floor and to work in close proximity to packaging equipment. The working environment is clean and not normally subject to hazardous environment or conditions.

Approximately 10 percent travel between Sharp sites and to off‑site assignments.

Travel to customers and to equipment suppliers on an as needed basis.