Validation and Technical Support Engineer

Piper Companies is actively seeking a Validation and Technical Support Engineer to join a global pharmaceutical organization producing innovative, injectable diabetes and obesity treatment. The successful candidate will provide validation and technical support through the preparation, execution, data analysis, and report writing for various protocols, ensuring compliance with regulatory requirements and industry standards. This person will join a reputable company that is looking to double both in size and production in the coming years. This is a Monday - Friday, traditional hours role location in the greater Raleigh, NC area.

Responsibilities of the Validation and Technical Support Engineer:

• Provide validation and technical support through the preparation, execution, data analysis, and report writing for IQ, OQ, and PQ protocols.
• Take ownership of Change Requests (CRs) related to project validation responsibilities.
• Perform compliance and technical reviews/approvals of protocols and protocol data.
• Author Implementation Plans (IMPL), validation plans (VPLs), and other key validation documentation.
• Ensure compliance of validation protocols executed are aligned with local, corporate, and regulatory regulations.
• Lead validation failure investigations and non-conformities utilizing root cause analysis techniques.
• Create and modify existing validation procedures and configuration item lists (CILs) as required.
• Experience with IT systems such as PAS-X, SAP, and Aveva PI, and computerized equipment such as autoclaves, packaging, assembly, filling, cart washers, utensil washers, CIP/SIP, and formulation.
• Participate in FAT, SAT commissioning efforts for computerized equipment, automation systems, and processes.
• Identify process improvements before equipment, systems, or processes are placed under change control during validation.
• Assist with development and improvement of system user requirements.
• Coordinate and communicate with IT and Automation teams to ensure validation efforts are met.
• Lead validation activities assigned by the overall project manager and other accountabilities, as assigned.

Qualifications of the Validation and Technical Support Engineer:

• BA/BS degree in Engineering, Computer Science, or applicable technical degree or proven equivalent relevant work experience.
• MA/MS/MBA degree preferred.
• Minimum of five (5) years of validation or quality-related discipline experience in the pharmaceutical environment.
• Experienced with regulatory requirements and industry standards for pharmaceutical and/or medical device manufacturing, such as 21 CFR Part 11, GAMP5, ISO, electronic records retention, configuration items list, FDA, and ICH guidance documents.
• Demonstrated experience using root-cause analysis techniques to solve problems.
• Ability to read, write, and understand complicated product documentation.
• Demonstrated leadership and project management skills, including two-way communication skills with customers (internal/external), project team, and management.
• Ability to write technical documentation based on equipment manuals.
• Experience in pharmaceutical manufacturing preferred. Knowledgeable in GMP concepts.
• Knowledge of standard operating procedures with attention to high-level concepts.
• Ability to manage multiple tasks/deadlines and prioritize properly based on process needs.
• Demonstrated strong skills in change management.

Compensation of the Validation and Technical Support Engineer:

• $50-$60/hr depending on years of experience
• Benefits: Medical, Dental, Vision, 401k, and sick leave if required by law

This job opens for applications on 3/24. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: Validation, Technical Support, Pharmaceutical, Quality Control, Change Management, Root-Cause Analysis, SAP, PAS-X, Aveva PI, GAMP5, GMP, 21 CFR Part 11, ISO, FDA, ICH

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Salary : $50 - $60