Senior Pharmaceutical Validation Engineer

Employer
PYRAMID Laboratories, Inc.
Location
Costa Mesa, CA
Posted
Oct 06, 2017
Jobs Outside Higher Education
Other Jobs Outside Higher Education
Institution Type
Outside Academe


Job Description

POSITION SUMMARY:

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.

PRINCIPAL DUTIES:
  • 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.

MINIMUM QUALIFICATIONS/REQUIREMENTS:
  • 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.

Company Description
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:

Aseptic Filling
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

af30e32610

Tue, 26 Sep 2017 11:22:32 PDT

PI99709066