Senior Validation Specialist - Pharmaceuticals
Company: Cameron Craig Group
Posted on: January 15, 2022
We are actively seeking a Validation Specialist (Sterile -
Injectable and Blow Fill Seal) to join its growing team in the
Charlotte NC area. The Validation Engineer/Specialist will plan and
schedule qualification projects, including the ability to develop,
perform, maintain, and support qualification activities and
documentation in accordance with cGMP requirements. Provide support
to the vendor's installation and qualification activities.
- Qualification of Sterile - Injectable and BFS manufacturing
facilities and equipment in compliance with FDA regulations,
Quality management systems, Good Manufacturing Practices and 21 CFR
Part 11 (Electronic Records and Signatures) requirements.
- Experience in Equipment, Utility and Facility Qualification in
GMP environment. This position will interface with clients, lead
team members of Qualification, Engineering, Operations and QA
- Provide subject matter expertise in the qualification process
of a variety of utility, facility and process equipment.
- Responsible for preparing and executing qualification documents
for a variety of Utility, Facility and Process/Packaging equipment.
This includes Factory Acceptance Testing, User Requirement
Specification, System Impact Assessment, Design Qualification, Site
Acceptance Testing, Installation Qualification, Operational
Qualification, Performance Qualification, and Periodic review of
equipment qualification status.
- Develop qualification protocols and reports for the Facility,
Manufacturing Equipment, Packaging Equipment, Utilities.
- Assist in the generation of User Requirement Specification and
Impact Assessments to ensure the functioning of the equipment and
determine the impact of the system.
- Assist in creating the Standard Operating Procedures for
manufacturing/packaging equipment and qualification related
- Able to follow-up and resolve comments, deviations, and
technical issues with the qualification activities.
- Provide support in generation of Master Validation Plan. Ensure
it is current and the scheduled activities being implemented per
- Must be able to work independently and in team environment to
conduct qualification activities using a science and risk based
- Must be able to lead project with minimal supervision.
- Coordinate the proper approval of plans, requirements, and
- Review completed protocols for completeness, cGMP compliance
and data acceptability.
- Conduct regular project review meetings within the team, with
cross functional teams and with the vendors to control the project
time to time.
- Contribute to department efficiency initiatives.
- Support in presenting and defending qualification
protocols/reports during regulatory inspections and internal
- Bachelor's degree in relevant scientific discipline
(Engineering, Chemistry or Science) required. Equivalent experience
will be considered.
- Minimum of 3 years of experience in qualifying the Sterile -
Injectable and Blow Fill Seal manufacturing equipment and Facility
required. 7 years of overall experience is preferred.
- Must have excellent verbal communication and technical writing
- Must have experience with aseptic gowning requirements and
Clean room qualification.
- Must have experience with usage of data loggers and Kaye
- Hands-on experience in project planning, development, and
execution of pharmaceutical equipment qualification
protocols/reports for Sterile manufacturing equipment (Compounding,
and Filtration Vessels), Autoclave, Lyophilizer, Vial Filling Line
(Washer, Filler, Depyrogenation Tunnel) Vial Labeler, CCIT,
Serialization and Aggregation, Pre Filled Syringe Line (PRILM), BFS
(Filling, Deflashing), Pouching Machine and PFS Labeler.
- Hands on experience with interpreting P&ID's, Block Flow
Diagrams, Process Flow Diagrams, Piping and instrumentation
Diagrams, Mass and utility balances, equipment/system layouts,
wiring diagrams, and specifications in planning and performing
- Demonstrated experience with process valve matrix, process
sequence logics, functional design specification (FDS), process
control sequences, CIP/SIP sequences.
- Familiarity with qualification of Purified Water System,
Compressed Air, Nitrogen Gas, Water for Injection, Pure Steam,
HVAC/AHU, EMS/BMS system.
- Familiarity with statistical knowledge of ANSI/ASQ sampling
scheme, Control Limits and Process Capability Analysis is
- Excellent knowledge of pharmaceutical quality systems and
- Ability to work in a team structure; plan, organize and
- Ability to analyze quantitative data, create and/or edit
written reports and be able to process information.
- Proficient in Microsoft Word, Excel, Power Point and
Keywords: Cameron Craig Group, Rock Hill , Senior Validation Specialist - Pharmaceuticals, Healthcare , Monroe, South Carolina
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