Job Description

Plastikon Healthcare is looking for a Senior Validation Specialist responsible for generation and executions of all processes, equipment changes, and implementation of new systems, equipment, and product transfers. This position will also lead all Process Validations providing critical documented evidence that a manufacturing process consistently produces a product meeting predetermined specification. This position will support all new and existing equipment/system commissioning, qualification & validation, by providing technical information, writing, and review of URS documents. Supports engineering, QA and validation efforts by performing (FAT) Factory Acceptance Testing and (SAT) (Site Acceptance testing), commissioning and all site testing/validation activities. Writes and executes protocols for qualification & validation events in alignment with QA/QC. Writes and revises procedures to support existing and new systems. Maintains professional and technical knowledge by attending educational workshops and reviewing professional publications.

Position Responsibilities:

• Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing and laboratory equipment.
• Provide technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGXP, CFR 21 Parts, 11, 210 & 211, EU Annex 11, ICH Q7, Q8 & Q9, and other applicable regulations, procedures, and industry guidelines.
• Provide engineering support for new equipment upgrades and special projects.
• Develop project plans and schedules; estimate time; track project progression.
• Participates in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards.
• Report on project progress, limiting factors and issues, changes in project scope, develop contingency plans, and resolve issues impeding progress.
• Collaborate with production personnel to develop new projects, identify limiting factors in current projects, and create/maintain relationships.
• Participates in teams assembled to specify, install, validate, troubleshoot, and maintain systems and equipment.
• Participates in deviation investigations to help identify root causes and define corrective and/or preventative actions (CAPA).
• Write, review, and execute protocols.
• Ability to interpret and relate Quality and Best Practice Qualification and Validation standards for implementation and review.
• IQ/OQ/PQ activities for facilities/utilities
• Ability to work individually and within a team environment.
• Comply with all company Environmental Health and Safety and Department of Health requirements.
• Other duties as assigned.

ESSENTIAL FUNCTIONS

Reasonable Accommodations Statement

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

POSITION QUALIFICATIONS

SKILLS & ABILITIES

Minimum Requirements: BS in Engineering or in another discipline with equivalent experience, with 5+ years hands-on experience with facility validation, processes, and systems. ISO execution, Quality Systems, commissioning, and qualification preferred and is used to determine job level (I-IV).

Skills/Qualifications:

• Excellent attention to detail and working knowledge of FDA Regulations/Guidance and/or Good Manufacturing Practices.
• P&ID reading, commissioning and qualification principles, ISO Systems.
• Technical knowledge and experience with validation/qualification of processes, equipment, utilities, facilities and/or computer systems, required

LANGUAGE SKILLS

Required reading, writing, and speaking fluently in English.

PHYSICAL DEMANDS

While performing the responsibilities of the job, the employee is required to talk and hear. The employee is required to sit, stand, walk, reach with arms and hands, lift objects, and use their hands and fingers to handle or feel. The employee is occasionally required to climb or balance, stoop, and kneel, crouch or crawl. Vision’s abilities required by the job include close vision. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

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.

Job Tags

Similar Jobs