Validation Engineer - Largo, United States - Formulated Solutions

Description

THE COMPANY:

Formulated Solutions is redefining the Pharmaceutical and Self-Directed Consumer Healthcare CDMO experience through creativity and invention; delivering our world class Marketing Partners unmatched formulations, innovative packaging and cost effective, reliable supply.

Formulated Solutions is and shall always be a company of people with the knowledge and dedication to provide our Marketing Partners with a single source solution for delivering quality and innovative products to market.

We shall embrace changes and new opportunities as a vehicle to continually develop and grow sustainable relationships.

As a company we shall never accept anything less than a culture that fosters creativity, growth, and profitability for both our Partners and the company.

PRIMARY PURPOSE:

The Validation Engineer will be responsible for qualifying equipment and processes to ensure compliance with regulatory requirements and industry standards.

This position requires a strong understanding of GMP guidelines and a meticulous attention to detail to ensure the quality and reliability of our manufacturing processes.

Must demonstrate proactive, positive, "can-do" leadership by setting an example for others to follow.


MAJOR DUTIES AND RESPONSIBILITIES:

Responsibilities:

• Develop and execute validation test plans and protocols for equipment, processes, and systems in accordance with GMP regulations and company standards.
• Perform qualification studies, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new and existing equipment and processes.
• Owner of the validation system and the validation master plan
• Document and analyze validation test results and prepare comprehensive reports that demonstrate compliance with regulatory requirements.
• Identify and address deviations or non-conformances during validation activities and implement corrective and preventive actions as needed.
• Support regulatory inspections and audits by providing validation documentation and participating in related activities as required.
• Facilitates risk analysis as part of the validation and suggests risk minimization measures.
• Perform equipment, utility system, and computer system periodic reviews in line with cGMP standards.
• Identifies necessary re-validations over the asset life cycle and coordinates the measures required for these.
• Draft Standard Operating Procedures (SOP) related for new operational equipment, processes, or systems.

Health, Safety, and Environmental Compliance:

• Ensure that engineering activities and processes comply with all relevant health, safety, and environmental regulations and standards.
• Promote a culture of safety within the engineering team and the broader manufacturing plant.

Technical Excellence and Innovation:

• Champion technological innovation and research, staying up to date with industry trends and emerging technologies to guide the team's decision-making process.
• Promote a culture of continuous improvement, encouraging engineers to explore and implement new tools, technologies, and practices to enhance product performance and reliability.

Talent Development and Training:

• Stay current with industry trends, best practices, and regulatory changes related to validation activities, and implement improvements, as necessary.

Cross-Functional Collaboration:

• Collaborate with cross-functional teams to establish validation requirements, specifications, and timelines for new qualifications.

Risk Management and Compliance:

• Identify potential risks and challenges associated with engineering projects and develop mitigation strategies to address them.
• Ensure compliance with relevant regulations, standards, and industry best practices in all engineering activities.

QUALIFICATIONS:
Required

• Bachelor's degree in Engineering, Pharmaceutical Sciences, or a related field.
• Minimum of five (5) years of experience in validation within a GMP environment.
• Strong understanding of GMP regulations, FDA guidelines, and international regulatory requirements.
• Experience with validation processes for equipment, utilities, facilities, and computerized systems.
• Excellent analytical and problem-solving skills with the ability to interpret and apply regulatory requirements to validation activities.
• Strong written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams.
• Detail-oriented with a high level of accuracy in technical documentation writing and reporting.
• Ability to manage multiple projects and priorities in a fast-paced environment.
• Good communication and interpersonal skills to facilitate collaboration across different teams and stakeholders.
• Proactive problem-solving skills and the ability to handle multiple priorities in a fast-paced environment.

Preferred Additional
Five or more years' experience in a cGMP environment is preferred.


CRITICAL SKILLS AND ABILITIES:

• Proficiency in all Microsoft Office applications
• Ability to read and understand blueprints, electrical diagrams, and other facility related drawings.
• Extra considerations offered to candidates with cGMP, FDA and/ medical device experience.

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