Validation Engineer I

Sharp Packaging Services•Allentown, PA

4d•Hybrid

About The Position

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.

Requirements

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.
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 project deadlines.
Good oral communication, organizational and planning skills are required.
Passport required.

Nice To Haves

Familiarity with quality engineering practices in packaging operations is desired.
Relevant ASQ certification is desired.

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