Senior Pharmaceutical Validation Engineer
PYRAMID Laboratories, Inc. is a Bio-pharmaceutical Contract Manufacturing and Analytical Services facility located in Costa Mesa, California. The company is seeking a Senior Validation Engineer whose primary responsibilities include designing and implementing manufacturing validation programs as well as ensuring that all cGMP requirements are satisfied.
- Develop validation protocols in compliance with IQ/OQ/PQ requirements and industry guidelines as related to quality control/assurance manufacturing activities.
- Design and implement protocols to validate and monitor the various quality control/assurance manufacturing activities or systems, such as, WFI, air handling, etc., in compliance with cGMP and industry guidelines.
- Develop and execute steam sterilization (autoclave) protocols, IQ/OQ/PQ, maintenance and trouble-shooting.
- Ability to participate in vendor, client, internal and FDA audits, and generate the appropriate documentation.
- Perform all duties and quality control/assurance/validation activities according to the applicable guidelines, i.e. FDA, cGMP, ICH etc.
- Ability to validate, calibrate, maintain and trouble-shoot various equipment as required for all quality control/assurance activities.
- Ability to initiate problem-solving and technical decision-making commensurate with level of experience.
- Written and oral skills at a level commensurate for interaction with staff, vendors and clients as necessary.
- Perform Risk-Based Analysis and validate various Part 11 Systems.
- Implement and validate various control systems.
- Direct, plan, design, and coordinate development project activities.
- Provide technical expertise to all project activities. Participate in short-and long-term strategic planning.
- Perform other related duties and responsibilities as assigned.
- Bachelor's or Master's degree in chemistry, biology, or related scientific discipline and a minimum of ten (10) years experience in the same or closely related cGMP environment.
- Demonstrated competence in related manufacturing protocols and QA procedures.
- Demonstrated ability to effectively supervise and direct personnel and to plan and direct medium to large projects.
- Oral and written communication skill must be at a level appropriate for effective in-house communications, client contact and report preparation.
PYRAMID Laboratories, Inc. (PYRAMID) is a rapidly growing Contract Aseptic Manufacturer and Analytical Service provider for the pharmaceutical and biotechnology industries.
PYRAMID offers a wide array of services for all phases of drug development, including:
Formulation & Process Development
Lyophilized Product Formulation & Cycle Development
Product Process Validation
Clinical and Commercial Vial & Syringe fill / finish
Clinical and Commercial Lyophilization batches
Labeling & Packaging
Analytical Quality Control Laboratory Services
Analytical Method Development & Validation
API & Drug Product Stability Studies
Costa Mesa, CA
Tue, 26 Sep 2017 11:22:32 PDT