Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focused on development and cGMP manufacturing of biopharmaceutical products derived from mammalian cell culture. We provide a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, our services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support. We also provide a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization.
We are dedicated to the improvement of global patient outcomes by delivering world-class services. Our expertise enables us to partner with our customers to advance their products from clinical development to commercial launch. Do you possess the skills and expertise below to improve patient lives and support patient innovative therapies? If so, apply today!
Relocation Bonus for West Coast Applicants available! H-1B Transfers Welcomed!
Summary and Qualifications:
This position shall provide validation support for computerized systems, networks, and software that have been newly installed, upgraded, replaced and/or modified in the cGMP Manufacturing Facility as well as its related manufacturing support areas, which may include Facilities/Engineering, Quality Assurance, Supply Chain, and Quality Control.
Essential Duties And Responsibilities:
Provide input and assist in change control assessment and Part 11 assessment for validated systems.
Coordinate and oversee validation protocol execution or validation activities with cross-functional departments.
Audit/inspection readiness in preparation for client and regulatory agencies as well as support for validation documentation and processes during the audits and inspections.
Provide input on the development of validation policies and procedures.
Effectively interact and provide validation guidance to other departments.
Assist department management in developing realistic time and resource requirements for validation activities in support of company expectation.
Help author Requirement and Specification for computerized equipment, systems, software and processes.
Generate and execute Installation, Operational and Performance/Process qualification (IQ, OQ, PQ) protocols and final reports.
Knowledge of validation principles, standard concepts, practices, procedures and requirements in cGMP-regulated environment with special focus on computerized systems and software.
Experience and knowledge of Data integrity guidance and regulations.
Understanding of Good Automated Manufacturing Practice (GAMP), cGMP, ASTM E2500, SDLC, Risk Assessment, EU Annex 11 and 21 CFR Part 11 Electronic Records and Electronic Signatures.
Additional experience may include but not limited to knowledge and understanding of manufacturing processes and equipment/process gap analysis.
Experience with supporting audits and inspections
Knowledgeable with Programmable Logic Controllers (hardware and software).
Takes accountability for actions, drives results, and learns from mistakes.
Practical experience with quality risk management and risk-based validation.
Demonstrates excellent organizational and time management skills.
Required Education and Experience:
Requires a BA/BS in a Computer Science, Engineering, Biology, Chemistry, or other related field.
Minimum of 5 years of computer system/software validation experience or an equivalent combination of education and experience.
Including experience in the pharmaceutical, biopharmaceutical or medical device industry with GMP experience.
EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER
Avid Bioservices do not discriminate against any employee for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or because he or she is a protected veteran.