Validation Engineer - Largo, United States - Formulated Solutions

Formulated Solutions Largo, United States

2 weeks ago

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

Bachelors 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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