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Quality Assurance Validation Specialist
2 months ago
PSC Biotech is dedicated to providing essential services to the life sciences sector, ensuring that healthcare products are developed, manufactured, and distributed to meet the highest standards and comply with all relevant regulatory requirements.
Our Mission
Our aim is to enhance our clients' success, and you can contribute to our achievements. We take pride in our global team of skilled professionals and experts located in strategically positioned offices worldwide.
Your Responsibilities
We are seeking a seasoned Validation Engineer to assist with various commissioning, qualification, and validation projects. Your responsibilities will include:
- Creating and executing Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Validation (PV) protocols, as well as associated test methods, procedures, reports, and risk assessments for a variety of pharmaceutical and manufacturing equipment, facilities, utilities, and systems.
- Contributing to the formulation of master plans and validation strategies for diverse manufacturing processes, ensuring adherence to regulatory standards.
- Collaborating with cross-functional teams to guarantee alignment and successful execution of validation activities and deliverables.
- Conducting risk assessments and supporting risk mitigation strategies while efficiently addressing deviations.
- Providing assistance during regulatory inspections as required.
- Identifying potential risks throughout the validation lifecycle and effectively managing change controls.
- Performing periodic reviews and requalification assessments as necessary.
- Ensuring all documentation is accurately reviewed, approved, stored, and managed.
- Working with vendors and contractors to ensure compliance with validation requirements and specifications.
- Driving initiatives for continuous improvement to enhance validation processes, documentation practices, and compliance standards across the organization.
- Taking on additional responsibilities as needed to ensure successful project completion.
Qualifications
To be considered for this role, candidates should possess:
- A Bachelor's degree in a relevant engineering discipline.
- A minimum of 5 years of experience in equipment commissioning, qualification, and validation engineering, with a proven track record in developing and executing validation protocols within the pharmaceutical manufacturing sector.
- In-depth knowledge of regulatory requirements and guidelines, including cGMP and FDA standards.
- Experience with the validation of pharmaceutical manufacturing equipment, facilities, utilities, and computerized systems.
- Advanced understanding of validation principles and methodologies.
- Excellent technical writing skills, with over 5 years of experience in drafting, developing, reviewing, and authoring technical documentation, including protocols, procedures, and risk assessments.
- A strong grasp of engineering specifications (URS, DS, FS, etc.).
- Attention to detail with a focus on accuracy and compliance.
- The ability to manage multiple priorities and effectively prioritize tasks.
- Strong communication and interpersonal skills.
- Robust analytical skills with effective problem-solving and troubleshooting abilities.
- Willingness to travel as necessary for project assignments and client engagements, adapting to various locations and work environments.
Equal Opportunity Employment Statement:
PSC is committed to a policy of Equal Employment Opportunity for all employees, interns, and applicants. Our policy is to comply with all applicable federal, state, and local laws regarding employment discrimination. The Company prohibits discrimination against qualified individuals in all aspects of employment.
