Overview
Quality Engineer Jobs in Andover, MA at Orbis Clinical
Title: Quality Engineer
Company: Orbis Clinical
Location: Andover, MA
Job Title: Contract Lead Engineer, Quality Validation
Location: Andover, MA (Hybrid)
Contract: 12 months
Job Description Summary
The Lead Engineer, Quality Validation will be responsible for providing quality and technical support for qualification and validation activities related to process validation for both internal customers and CMOs/CTLs. The individual will support and facilitate the development of project plans, qualification protocols and reports for all stages of the qualification process.
Primary Responsibilities include:
Provide quality oversight for drug product process technology transfers, including development and engineering activities to be leveraged
Provide quality oversight for drug product process qualification/validation protocol, exception, and report reviews
Provide quality validation oversight at contract manufacturing organizations (CMOs), including continued process verification (CPV), product quality reviews (PQR), supporting investigations and deviations as needed
Adhere to regulatory guidance, policies, and procedures for technology transfer and process validation
Independently coordinate and directly interface with multiple departments both internally and with our contract manufacturing and testing organizations
Use risk management principles for qualification and remediation efforts
Provide regular updates directly to Management
Perform other related duties as assigned
Education and Skills Requirements:
8-12 years of relevant experience and bachelor’s degree in science or related field. Biopharmaceutical or Pharmaceutical experience preferred
Direct experience in process qualification and validation using FDA and ICH guidance required.
Direct experience working with a CMO and drug product manufacturing preferred
Must have in-depth understanding and application of GMP and validation principles, concepts, practices and standards in the US and internationally
Experience in analytical method qualification and validation using FDA, USP and ICH guidance also preferred.
Knowledge of biologics/gene therapy processes desirable
Able to execute complex concepts, techniques, and standards and new applications based on quality principles and theories
Able to implement solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness
Demonstrates knowledge of industry best practices and trends
Excellent verbal, written, and interpersonal communication skills are required
EEO and Reasonable Accommodation Statement:
Orbis Clinical provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, housing, age, disability or genetics.
We will consider all qualified applicants for employment, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws.
By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.
