- 191339 - Validation Engineer
- Up to $30.00 DOE
- 7 mos
- Chipton-Ross is seeking a Validation Engineer for an opening in Miami, FL
The Validation Engineer participates as an active member of a dynamic team with high involvement and engagement in cell culture media manufacturing operations. Supports the Validation and Quality Control programs within the Miami, Florida site .
The Validation Engineer participates as an active member of a dynamic team with high involvement and engagement in cell culture media manufacturing operations. Supports the Validation and Quality Control programs within the Miami, Florida site. Author and execute protocols in support of new equipment, instrumentation, Computer Systems, and analytical method validation and method transfer. Complete validation reports and resolution of deviations. Work closely with business stakeholders technical support groups and QA to thoroughly investigate validation discrepancies and drive best practice for system validation. Provide direction to vendors in the qualification of equipment. Effectively liaison with representatives from originating / sending sites, R&D, Quality Control, etc. to ensure design and readiness for laboratory test method validations, verifications, and transfers to support NPI / transfer projects. Provide support in the area of troubleshooting of new / existing equipment and test methods. Support change management system and assess for validation impact. Execute validation deliverables as defined by the the client's Quality Management System. Assure compliance to appropriate regulatory requirements. Initiate quality records when not in compliance and inform Quality of noncompliance and proposed corrective activities. Assure validation support structure and document handling systems are maintained. Ability to function efficiently and independently in a fast paced, changing environment. Make effective decisions relative to position requirements. Work with functional teams to achieve operational goals. Communicate issues and concerns to management.
Minimum of 4 years of validation experience in Pharmaceutical / Biotechnology industry. Hands-on experience in Quality Control laboratory instrumentation and equipment qualification. Experienced in developing IOQ, CSV, method validation and method transfer plans and protocols. Thorough knowledge of quality management systems and validation principles for equipment, laboratory test methodologies, regulatory agency expectations, and industry trends. Knowledge and experience in engineering, chemistry, microbiology, and other sciences to effectively meet the responsibilities of the position. Possesses technical and analytical skills to be able to lead root cause investigations in a timely and effective manner. Strong technical writing, effective verbal communication, and interpersonal skills. Ability to prioritize and perform multiple tasks, with minimal supervision required. Ability to work in teams to obtain results, self-motivated, and ability to effectively manage conflict. Working competency of Microsoft Word, Excel, Power Point, Project, and statistical programs.
Job Complexity: Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Internal and external contacts often pertain to company plans and objectives.
Supervision: No direct reports. Will be expected to determine methods and procedures on new assignments and may provide guidance to other personnel. Exposure to industrial machinery, sharp and moving parts, electrical and other energy sources. Personal Protective Equipment (PPE) required including but not limited to lab coats, hair / beard covers, shoe covers, gloves, ear protection, eye protection and specialized cleanroom suits and head coverings as required. Exposure to fumes and chemicals such as raw materials, cleaners, etc. Infrequent exposure to high frequency noise. Ability to lift up to 25 pounds repetitively. Must be flexible to meet requirements of qualification work schedules.
Accredited Bachelor’s Degree in Science or Engineering is required.
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 x252 or (800) 927-9318 x252
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.