- 193451 - Test Method Validation Engineer II
- CA-Southern California - San Diego
- Up to $35.00 DOE
- 4 mos
- Chipton-Ross is seeking a Test Methods Validation Engineer II for an opening in Carlsbad, CA.
The role is responsible for Test Method Validation within the Quality Assurance group of a recently built enzyme manufacturing facility serving pharmaceutical customers, ensuring the applicable assay is suitable for its intended use. This operation is part of our Biosciences Division (BID), part of our Life Sciences Solutions Group (LSG). BID is experiencing outstanding growth supporting exciting markets: Academia, Research, Biotech, Pharma, Cell and Gene Therapy and Medical Devices.
We are looking for a self-driven, reliable and resourceful Test Method Validation Engineer to develop and support the successful execution and implementation of test method validations, ensuring assays produce reliable (repeatable and reproducible) analytical results suitable for its intended use.
Develop and support execution of Test Method validation protocols and associated validation reports while adhering to the site Change Management process.
Supports writing procedures for Test Method validation protocols and reports, where applicable.
Supervises vendors for qualification functions, where necessary.
Support assay risk mitigation by assessing the suitability of methods used to accept and/or reject products.
Support manufacturing assay implementation/launch including but not limited to validation plans/reports, user requirement specifications, traceability matrices, etc.
Maintains all qualified and validated assays in compliance with policies, guidelines and procedures.
Provides technical support and guidance on equipment qualification issues
Manage projects of varying scope and complexity.
Drive a culture of continuous improvement by employing Practical Process Improvement concepts and reporting metrics and communicating internally to diverse audiences.
Provide knowledge and insight into qualification and validation activities and the ability to work effectively with engineering and operations teams in completing these tasks.
Minimum of 2-4 years’ experience within the Medical Device or Pharmaceutical Industry supporting Regulated Products.
Knowledge, Skills, Abilities (Required)
Excellent communication, collaboration and interpersonal skills with the ability to partner with and influence key stakeholders including Manufacturing, Technical Operations, Equipment Services, etc.
Strong capability to leverage work with diverse teams, facilitate agreement, build collaborative relationships and focus on customer needs.
Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency.
Strong analytical ability including the ability to effectively use data in problem solving and to evaluate process changes and impacts.
Compliance with regulated quality management system standards (e.g., 21 CFR Part 820, 21 CFR part 210/211, ISO 9001, ISO 13485, MDSAP, ICH Q7, Eudralex volume 4 requirements and excipient manufacturing regulations).
Quality tools e.g. FMEA, Risk Analysis, Root Cause Analysis
Global Systems e.g. TrackWise, AGILE, E1, LIMS
Proficient in Computer applications and software (Microsoft Excel, Outlook, Word, Access, Project); compliance specific software programs (Agile, Trackwise, LIMS, Master Control, ERP, etc.).
Knowledge, Skills, Abilities (Preferred)
Experience with biological manufacturing processes.
Project Management advanced experience.
Certified Lean Professional or Six Sigma
Bachelor’s degree from an accredited college/university with a preference for Science, Engineering, Biochemistry, Biotechnology, Biology or Biomedical Engineering.
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x307 or (800) 927-9318 x307
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.