Bioserv, a Sorrento Company, is a leading contract manufacturing service provider whose core competencies are centered in aseptic and non-aseptic drug, medical device or reagent manufacturing; bulk formulation filtration; fill/finish; lyophilization services; labeling and finished goods assembly; kitting and packaging; as well as controlled temperature storage and distribution services to support Pre-Clinical, Phase I and II Clinical Trial drug products.
WHAT YOU’LL DO:
The Validations Manager/Validations Engineer is responsible for identifying Validation requirements for equipment, processes and analytical methods for Bioserv Corporation and Bioserv customers. The Validations Manager/Validations Engineer is responsible for responding to validation issues, authorizing Validation documents, revising existing Validation documents, analyzing Validation data, recommending and implementing remedial/corrective actions and overseeing the maintenance of the Validation database.
Essential Duties & Responsibilities
- Lead and assist team members with validations: write IQ/OQ/PQ, review equipment, utilities, HVAC, facilities validation protocols/reports (URS/DQ/IQ/OQ/PQ)
- May act as process owner or QA reviewer for change controls of protocols, SOPs, specifications, validations, and Forms related to Validation activities; ensure Change Control activities are well documented; follow up on open Change Controls and assess impact of changes on validation and key systems
- Coordinate validation schedules with departments and customers
- Execute validation
- Analyze results and generate test reports and recommendations
- Troubleshoot validation methods and/or instrumentation
- Provide technical expertise for the generation of protocols and review of reports of validations of temperature controlled units, HVAC systems, water supply, autoclaves, depyrogenation ovens, Quality System computer programs, analytical equipment and methods
- Task and support QA personnel to meet Quality and Manufacturing needs
- Perform and/or review quality investigations and customer processes for CAPAs, NCMRs, Complaints, and Deviations that are related to validations; review reports to ensure root cause analysis was performed using Quality Tools (e.g. Ishikawa Diagram, 5 Why's, DMAIC, etc.)
- Perform or assist with preparation for FDA and other regulatory agency audits, inspections and customer audits
- Perform or assist in internal audits and external audits; write internal audit reports and follow up on completion of any open corrections or corrective actions deemed necessary that were communicated and documented to the auditee
- Ensure adequacy of validation procedures for phase appropriate cGMP compliance; must be able to identify deficiencies and discrepancies during internal audits, walk-through, for cause or impromptu audits and documentation audits; ensure management is notified and actions are taken to correct/address the quality problem(s) in a timely manner
- Provide oversight for the selection and performance of any validation contract services
- Prioritize work in alignment with company priorities
- Assist with all QA Functions in the department, as needed
EDUCATION AND QUALIFICATIONS:
BS or MS degree in a science discipline e.g., Life Sciences, Chemistry, Biology, Microbiology.
Minimum 5 years of experience in the pharmaceutical, biotech or related industry. Hands-on experience with a paper, electronic or hybrid systems preferred. Strong knowledge of validations s required. FDA and/or other regulatory agency experience required.
Specialized or Technical Knowledge, Licenses, or Certificates Needed
- Strong GMP background is required. Experience with writing GXP documents to meet requirements of phase appropriate cGMPs.
- Must have knowledge of 21CFR210-211, 21CFR600-610, ICHQ7, ICH QS, Q9 & Ql 0. Experience with authoring Quality Agreements, Business Supply Agreements, CMC Section, Analytical Reports, is a plus.
- FDA inspections and/or other regulatory agency inspections experience is highly desired.
- Strong written and verbal communication skills, specifically technical, scientific, communications and oral presentations.
- Support scientists who are on the leading edge of immunotherapies for the treatment of cancer.
- Earn a competitive salary that allows you to focus your attention on your passion.
- A comprehensive benefits package including medical, dental, vision, life and disability insurance, matching 401k, 10 paid holidays, and flexible PTO, plus stock options.
If this sounds like the right career to fit your personality and interests, please apply, we’re looking forward to meeting you!
Principals only. Recruiters, please don't contact this job poster.
Sorrento Therapeutics, Inc. is an Equal Opportunity Employer