Senior Validation Engineer

Sharp Services•Macungie, PA

About The Position

The Senior Validation Engineer independently plans, coordinates, and executes validation activities at Sharp facilities and at supplier or customer sites. The role covers equipment, processes, facilities, and computer systems, and validation work is performed in accordance with current good manufacturing practices. The position supports both the Conshohocken and Allentown facilities, with the employee based at one designated site. The work directly affects regulatory compliance and customer satisfaction. The engineer works with Operations, Sales, Engineering, Quality Assurance, customers, and the Validation Manager to establish validation approaches, develop and execute protocols, review results, and meet project schedules. The position has moderate supervisory responsibilities, including scheduling and monitoring project status, overseeing project team members, and supporting Validation staff with protocol and report development and execution. The role normally involves desk work, with periodic visits to the shop floor and work near packaging equipment. The environment is described as clean and not normally hazardous. Travel is approximately 10 percent between Sharp sites and for off-site assignments, with additional customer and supplier travel as needed.

Requirements

Six to ten years of related experience and/or training, or an equivalent combination of education and experience.
Independent certification of advanced quality skills and practices is required (for example, ASQ, CQE, or Six Sigma).
Broad knowledge of current validation principles and industry practices, including FDA regulations, cGMPs, and validation guidance documents.
Familiarity with quality engineering practices in manufacturing operations.
Knowledge of basic engineering principles and practices, including equipment automation controls.
Ability to independently plan and schedule validation activities, multitask, and meet project deadlines.
Ability to structure validation protocols in accordance with a planned validation approach.
Excellent written communication and technical writing skills; ability to produce sound protocols, summary reports, and clear documentation consistent with Good Documentation Practices.
Good oral communication, organizational, and planning skills; ability to present information professionally and address customer inquiries or complaints about validation.
Ability to read, analyze, and interpret scientific data, technical documents, engineering documents, and drawings.
Basic arithmetic skills and ability to apply complex mathematical operations, scientific notation, conversion factors, statistics, standard deviation, distribution and capability analysis, Design of Experiments, and sampling theory.
Good analytical, problem-solving, organizational, and negotiation skills, including the ability to interpret customer agreements and regulatory guidance.
Proficiency with Microsoft Office Suite, Windows operating system, Pilgrim SmartSolve, and Lotus Notes.
Ability to use hands to handle or write, and to speak and hear; regularly stand, walk, and reach; frequently sit; and occasionally lift or move up to 10 pounds.
Vision abilities including close vision, distance vision, and ability to adjust focus.

Nice To Haves

Bachelor’s degree (BS/BA) in a technical discipline from a four-year college or university is preferred.

Responsibilities

Support the Validation Manager in developing validation approaches, designs, and execution plans.
Represent the Validation function in reviewing and approving Change Controls involving equipment and processes.
Complete Validation review and approval of Sharp Master Production Records.
Develop validation requirements for projects involving new equipment, processes, facilities, and products.
Write IQ/OQ/PQ protocols for applicable equipment and systems in accordance with cGMP.
Supervise validation activities at the designated Sharp facility, including packaging, cleaning, HVAC, and computer systems.
Write process validation (PV) protocols specific to customer needs.
Communicate validation approaches and requirements to customers.
Monitor or execute assigned validation protocols.
Review executed protocols and prepare final reports.
Participate in customer audits concerning validation activities at Sharp facilities, as directed by the Validation Manager.
Participate in external regulatory audits concerning validation activities, as directed by the Validation Manager.
Schedule work, conduct daily project-status checks, oversee project team members, and support the Validation Manager as requested.
Support Validation staff in developing and executing protocols and reports, and review executed protocols for conformance with requirements and good validation practices.