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Title: Senior Engineer, QA Validation
Hiring Organization: Connexion Systems & Engineering
Our client is seeking: Senior Engineer QA Validation
Ideal candidate is someone with med device and has interest/touch of experience in the pharma world
The Sr. Engineer QA Validation will be responsible for providing quality and technical support for commissioning, qualification and validation (CQV) activities related to manufacturing equipment, processes, clean utilities for both internal customers and CMOs. The individual will support and facilitate the development of project plans, qualification protocols and reports for all stages of the qualification process.
Compensation, Benefits, and Employment Type
- Duration – Permanent
- Pay rate: 110-130K
- Job Location: Andover, MA
- Job# bh11531
- Date Posted: 7/15/2020
Primary Responsibilities Include
• Collaborate with systems owners and CMOs on the qualification
• Adhering to regulatory guidance for CQV policies and procedures for manufacturing and support systems
• Develop and support the qualification of systems and processes including but not limited to cell culture, protein synthesis, purification, shipping and packaging and labeling
• Develop and support the qualification of automated process control systems
• Develop and support the development and execution of FATs, SATS, DQ, IQ, OQ, PQ and other relevant validation lifecycle documents including but not limited to commissioning test plans, commissioning summary report reports and test scripts
• Supports the development of user requirements, detailed design specifications, functional and configuration specifications, and requirements traceability matrices
• Develops and supports gap assessments, GxP classification assessments, 21 CFR Part 11 assessment, and system criticality and impact assessments
• Independently coordinate and directly interface with multiple departments both internally and with our CMOs
• Direct experience in commissioning, qualification and validation required. Experience with manufacturing process and support systems, aseptic systems, filling and packing systems highly desirable
• Uses risk management principles for qualification and remediation efforts
• Support the periodic qualification review and maintenance of systems
• Interfaces with Regulatory agencies as required representing to authorities and regulatory inspectorates in matters relating to CSV
• Provide regular updates directly to Management
• Perform other related duties and special projects as needed
Education & Skills Requirements
• 8+ years of relevant experience and Bachelor’s degree in science or related field. Biopharmaceutical or Pharmaceutical experience preferred
• Direct experience working in validation using FDA, ICH and GAMP guidance
• Knowledge and experience in validation in highly regulated manufacturing environments
• Must have in-depth understanding and application of GMP and validation principles, concepts, practices and standards in the US and internationally
• Knowledge of biologics/gene therapy, chemical synthesis processes, analytical instrumentation desirable
• Prior QA experience 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
• Travel required, up to 25% domestic and international.
Candidates must be authorized to work in the U.S.
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