Job Title: Sr QC Equipment Validation Engineer.
Location: Seattle, WA.
Length of Assignment: 6 Months.
Relocation assistance will be provided.
Job Description:
We are seeking a highly skilled Senior Quality Control (QC) Equipment Validation Engineer for a 6-month assignment in Seattle, WA. The successful candidate will be responsible for ensuring the reliability and compliance of equipment and instruments used in the bio or pharmaceutical industry. This role requires expertise in equipment instrument qualification, Installation and Operational Qualifications (IOQs), data integrity, writing validation documents, system configuration, specifications, user requirements, and risk assessment.
Key Responsibilities:
Equipment Instrument Qualification (IQ): Perform comprehensive equipment qualification to ensure compliance with industry standards and regulations.
Installation and Operational Qualifications (IOQs): Execute IOQ protocols to verify that equipment is installed correctly and operates within specified parameters.
Data Integrity: Ensure the accuracy, reliability, and completeness of data generated by the equipment through rigorous validation processes.
Validation Documentation: Prepare and review validation documents, including protocols, reports, and procedures, ensuring they meet regulatory requirements.
System Configuration and Specifications: Contribute to the development and maintenance of system configurations and specifications to guarantee optimal performance and compliance.
User Requirements: Collaborate with stakeholders to gather and define user requirements for Equipment Validation.
Risk Assessment: Conduct risk assessments related to Equipment Validation processes and implement appropriate mitigation strategies.
Bio or Pharma Background: Apply industry-specific knowledge in the bio or pharmaceutical sector to address unique challenges and requirements.
GMP (Good Manufacturing Practice): Ensure compliance with GMP standards throughout the validation process.
Empower Software Knowledge: Familiarity with Empower Software is a plus and will be advantageous for this role.
Qualifications:
Bachelor's degree in Engineering, Life Sciences, or a related field or equivalent.
Proven experience in Equipment Validation within the bio or pharmaceutical industry.
Strong understanding of GMP regulations and compliance.
Familiarity with Empower Software is a plus.
Excellent written and verbal communication skills.
If you are a highly motivated and detail-oriented professional with a background in bio or pharma validation, we encourage you to apply for this exciting opportunity.
Job Type: Contract
Pay: $60.00 - $70.00 per hour
Expected hours: 40 per week
Experience level:
- 4 years
Schedule:
- Monday to Friday
Work setting:
- In-person
Ability to Relocate:
- Seattle, WA: Relocate before starting work (Required)
Work Location: In person