Validation Engineer/Specialist
Pharmasol - South Easton, MA

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Pharmasol is a small to midsize privately held contract development and manufacturing organization (CDMO) of personal care and pharmaceutical products for prominent global marketers and retailers. We are driven by our strong management team, continuous improvement philosophy and dedication to product quality and customer service.

We are currently seeking a QA Validation Engineer to provide validation support to design, development, installation and start-up of new equipment and processes. This position will also provide technical expertise and specialized knowledge in validation and change control for quality compliance while assuring that products and process continue to operate in accordance with company policies and procedures, and operate in accordance with company policies and procedures, FDA Regulations, ISO Standards and Canadian Medical Device Regulations, where applicable.

This position will:
- Serve as a Quality representative to improve awareness, visibility and communication on validation and change control initiatives to support departmental, functional, facility and corporate quality goals and objectives.
- Provide direction, input and review and approval of Engineering studies, FAT, IQ, OQ, and PQ validation protocols and reports for facilities, equipment, systems and utilities to ensure thoroughness, accuracy and compliance with company policies and procedures. Design and implement Quality Control and Validation protocols for new and existing manufacturing processes and products.
- Review and oversee change control activities related to facility equipment, systems and utilities to ensure that all changes are properly documented and impact assessments are properly conducted.
- Assess revalidation requirements and prepare recommendations and plans for such activities.
Effectively interface with manufacturing, quality control, quality assurance and engineering functions to assure compliance with regulations, standards, company policies and procedures. Ensure that validation and change control files are properly maintained in accordance with company policies and procedures.
- Support the transfer of new products and processes into manufacturing.
Provide project direction, coaching and mentoring for company personnel in the areas of validation and change control. Proactively initiates the development of streamlined systems to effectively identify and resolve quality problems.
- Provide support during regulatory inspections and customer audits. Identify and implement quality system improvements when gaps are identified through audits and departmental reviews. Proactively investigates, identifies and implements improved Quality practices.
- Track and monitor metrics related to the validation and change control processes and develop and implement programs designed to increase department and company employee awareness. Lead the implementation of continuous process improvement initiatives designed to meet or exceed internal requirements.
- Prepare and present trend reports to management.

Qualifications:
- Bachelor’s degree in an Engineering Field (Mechanical, Bioengineering, Manufacturing preferred)
- 4-5 years professional experience in a medical device/pharma manufacturing environment;
working knowledge of validation and change control processes with the ability to apply statistical techniques
- Knowledge of quality policies, FDA Regulations and ISO Standards for medical device or pharmaceutical operations;
- Excellent written and verbal communication and interpersonal skills with the ability to make verbal presentations to both large and small groups at a variety of levels both inside and outside of the company.


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