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Quality Assurance Validation Specialist
2 months ago
PSC Biotech is dedicated to delivering vital services within the life sciences sector, ensuring that healthcare products are developed, manufactured, and distributed in accordance with the highest standards and all relevant regulatory requirements.
Our mission is to elevate our clients' success, and you can contribute to our collective achievements. With a global team of skilled professionals and experts across strategically located offices worldwide, we take pride in the roles we play in helping our clients thrive.
Key ResponsibilitiesWe are seeking a seasoned Validation Engineer to assist with various commissioning, qualification, and validation initiatives. Your responsibilities will include:
- Formulating and executing Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Validation (PV) protocols, along with test methods, procedures, reports, and risk assessments for diverse pharmaceutical and manufacturing equipment, facilities, utilities, and related systems.
- Contributing to the creation of master plans and validation strategies for multiple manufacturing processes, ensuring adherence to regulatory standards and compliance.
- 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 investigating and efficiently resolving deviations.
- Providing assistance during regulatory inspections as required.
- Identifying potential risks and issues throughout the validation lifecycle, effectively supporting change controls.
- Performing periodic reviews and requalification assessments as necessary.
- Ensuring that all required documentation is accurately reviewed, approved, stored, and managed.
- Working with vendors and contractors to confirm that equipment and systems meet validation specifications and requirements.
- Driving continuous improvement initiatives to enhance validation processes, documentation practices, and compliance standards across the organization.
- Assuming additional responsibilities as needed to ensure successful project completion.
- 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.
- Comprehensive knowledge of regulatory requirements and guidelines, including cGMP and FDA standards.
- Experience in validating pharmaceutical manufacturing equipment, facilities, utilities, and computerized systems.
- Advanced understanding of validation principles and methodologies.
- Exceptional technical writing skills, with over 5 years of experience in drafting, developing, reviewing, and authoring technical documentation, including protocols, procedures, and risk assessments.
- Strong grasp of engineering specifications (URS, DS, FS, etc.).
- Detail-oriented with a strong focus on accuracy and compliance.
- Ability to manage multiple priorities and effectively prioritize tasks.
- Excellent communication and interpersonal skills.
- Strong analytical skills with the capability to problem-solve and troubleshoot effectively.
- Willingness to travel as necessary for project assignments and client engagements, adapting to various locations, cultures, and work environments.
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.
