Sr. Validation Engineer

Job Title: Sr. Validation Engineer

Department: Validation

JOB SUMMARY:

The Validation Engineer is responsible for the development and documentation of data to support the manufacturing and distribution of products in accordance with CGMP requirements.

Responsible for validation of new products, formulations, processes, and equipment including Process Validation, Equipment Qualification, and Manufacturing Equipment Cleaning Validation. and assists with development and review of documentation associated with Analytical Method Validation, Computer Validation, and qualification/validation of Analytical Instruments. Supports manufacturing operations, troubleshooting investigations, process improvement, cost reduction, sourcing of alternate materials/vendors, and transfer of manufacturing processes to new equipment/sites.

EDUCATION AND EXPERIENCE REQUIRED:

• Degree in Chemistry, Pharmacy, Industrial Pharmacy, Engineering, or other relevant discipline
• Two years or more (2 required, 4 preferred) experience in Manufacturing, Validation, or Quality in the pharmaceutical industry, preferably in semi-solid and/or liquid dosage forms.
• Basic understanding of pharmaceutical manufacturing processes for topical formulations such as solutions, suspensions, ointments, creams, gels, and shampoos).
• Must have a good understanding of Quality Management System concepts with an ability to oversee and execute the development, qualification, verification, validation, and transfer of cGMP-compliant formulations and manufacturing processes.
• Excellent leadership, communication, and collaboration skills in a cross-functional and fast-paced environment
• The proven ability to achieve results in manufacturing facilities is a must.

Other requirements include:

• Good organizational skills combined with strong logical thinking, strategic problem-solving abilities, and the ability to predict emergent issues and identify solutions.
• Working knowledge of Microsoft suite of software products including Excel, Word, and PowerPoint.
• A basic understanding of manufacturing equipment and processes, analytical testing, packaging, and product preservation.
• Excellent verbal and written communication skills, and the ability to effectively work across levels, functions, and companies. Fluent in English.
• A demonstrated ability to effectively plan and deliver tasks with expected quality outcomes in a timely fashion.
• The ability to work independently to reliably produce accurate comprehensive documents with minimal errors. The candidate must be extremely organized, detail-oriented, and able to work well in a team environment under tight deadlines.
• Proven multi-tasking ability with the capability to adapt quickly in a fast-paced work environment.
• Familiarity with CGMP’s, FDA/BOP guidelines and expectations, ICH standards, and industry best practices. Must develop detailed knowledge of company SOPs. Experience in interacting with regulatory agencies is preferred.

· Demonstrated leadership skills such as:

• The ability to effectively communicate, motivate employees, and achieve results in a team-based environment.
• Good interpersonal skills with the ability to interact and collaborate with internal and external groups.
• Strong negotiating skills and persuasive abilities, the ability to employ diplomacy judiciously, and to positively influence others.
• The ability to lead successfully and handle multiple challenges under pressure.
• Bilingual English / Spanish preferred

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Responsible for the development and issuance of Validation and Qualification Protocols, Summary Reports, and relevant ancillary documentation:
• Summarization for Validation Reports includes data review, performing data summaries, and the development of conclusions.
• Remedial actions and plans for implementation of remedial actions are also to be developed as required.
• Responsible for field work and interaction with various departments in connection with validation studies which may include validation project oversight, auditing, sampling, protocol execution, issuance of sampling/testing requests, or data acquisition as required.
• Oversees the development and implementation of Master Validation Plans.
• Assists in the development, review, or revision of documents pertaining to analytical methods, equipment, or processes as needed.
• Responsible for review and revision of new and existing Standard Operating Procedures and all associated Change Control Documents to determine and implement Validation/Re-Validation requirements in conjunction with Quality Assurance and Plant Management.
• Other duties as assigned.

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