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Validation Engineer

June 30, 2016


Location : Rocky Mount, NC

Description :

Job Summary/Goals:
Responsible for performing a variety of large-scale generic API (active pharmaceutical ingredient) chemical manufacturing tasks (rotovaping, chromotography, distillation, filtration, crystalization, chemical reactions) and activities related to advancing the product through various processes to achieve prescribed level of purity, quality and consistency. Works within closely defined processes and fills out process documentation as required.
Essential Functions:
– Receives training in process tasks, scientific theory and process documentation in order to become qualified under cGMP guidelines to perform generic API pharmaceutical manufacturing tasks. Level and complexity of training increases with demonstrated ability and successful task completion.
– Performs process manufacturing tasks including operation of large scale equipment, weighing, measuring, monitoring of raw and in-process materials to assure batches contain proper ingredients, quantities and process output.
– Prepared batches of solvents of other process ingredients as required.
– Performs and monitors multiple process tasks simultaneously in order to most efficiently drive product through production steps.
– Identified and informs supervisor of equipment malfunctions or process outputs that do not meet expected outcomes. May perform trouble-shooting of equipment or process problems and recommend solutions.
– Fills out process documentation timely and accurately as required by SOPs. Writes up instances where process failures occurred.
– Maintains manufacturing areas to identified standards of cleanliness and neatness; may involve sweeping, mopping floors, wiping down equipment, placing glassware and utensils in sterilizer, carrying away and appropriately disposing of trash.
– Performs any related hazardous waste duties in accordance with internal controlled documents, local, State and Federal Regulations.
High school diploma or GED; college course work in science highly desirable.
Minimum of 3 years experience in chemical or pharmaceutical process operations.
Other Requirements:
Mechanical aptitude and ability to use hands and tools to operate small/large-scale equipment; Ability to effectively read and understand English written SOPs/batch records; ability to write sufficiently and to quality standards to fill out documentation and write about events clearly and concisely. Interpersonal skills sufficient to communicate effectively with co-workers and supervisors and to act in concert with others to achieve tasks. Requires understanding of basic math skills to do mathematical calculations (i.e., weigh materials, calculate percentages).Ability to wear half face and full face respirators as required. Regularly engages in restricted manufacturing area activities. Hazardous environment with risk of exposure to chemicals, fumes, and heat and cold. Requires the ability to lift and carry up to 50 pounds; ability to crawl, climb, read, twist torso and stand for long periods of time. May need to push/pull material handling equipment up to 300 lbs.
Primary Function:
The Validation Engineer role supports the Commissioning, Qualification and Validation (CQV) for all aspects of a new sterile small volume parenteral (SVP) manufacturing facility. The Validation Engineer is responsible for ensuring that processes and systems such as those associated with facilities, utilities, equipment, sterilization and cleaning are fully qualified/ validated and perform as designed. This individual is responsible for developing, providing guidance, and executing validation strategies to provide documented evidence that processes, systems, equipment, facilities, utilities and cleaning, have been commissioned, qualified and/ or validated in a manner that meets or exceeds regulatory and cGMP requirements for manufacturing operations.
Major Duties and Responsibilities:
– Defining CQV strategies and oversight through the implementation of CQV plans for plant utilities, facilities and process equipment.
– Apply thorough understanding of cGXPs, relevant plans and SOPs, routine project procedures, project management, and other training as appropriate.
– Lead and perform variety of CQV projects/studies in areas that may include Sterilization, Equipment, Facility and Utility commissioning and qualification.
– Perform change control assessments and write/review CQV plans, study/test protocols, and summary reports. Manage execution of study/test protocols and review test results.
– Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
– Identifies deviations from established product or process standards and provide recommendations for resolving deviations.
– Collaborate closely with Project Management, Project Engineering, Process Engineering, Manufacturing, Quality, and Laboratory personnel in order achieve objectives according to stringent timelines.
– Establish validation plans, execution strategies and acceptance criteria based on established site, industry and regulatory standards. This individual will be knowledgeable of industry and regulatory standards. Lead the validation scope of projects with little to no supervision
– The role will be responsible for scheduling, planning and execution of validation projects for plant utilities, facilities, equipment and cleaning.
– Must be proficient in the ability to write validation protocols and reports.
– Develop qualification and validation (IQ, OQ, PQ,) documentation
– Experience and in-depth understanding of all system lifecycle deliverables from Commissioning & Qualification (C&Q) and Computer System Validation (CSV) documents through System Retirement. This includes deliverables such as Planning (Project Validation Plan or Validation Master Plan), User/Functional Requirements, Design Specifications, Design Qualification (DQ), Qualification Test Protocols (IQ/OQ/PQ), Process Validation (PV), Final Reporting, and support documentation (i.e. Traceability Matrices, SOP development, PMs, calibration, etc.)
– Technical writing, document control, and organizational skills is a must.
Skills Required:
– Minimum of 3-5 years of relevant validation experience
– Should have up to date knowledge on the validation requirements, practices and procedures.
– Must possess good technical writing ability.
– Should have knowledge to study, isometric, P&ID and as built drawings.
– Must be able to manage multiple tasks and work independently.
– Must be able to accept unexpected assignments as needed.
Additional Details:
HM wants to include some buzz words
Equipment Validation
Utilities Validation
Facilities Validation
Not interested in computer validation candidates

About Company:

ICONMA is a nationwide consulting firm with corporate headquarters in Troy, MI, providing Professional Staffing and Project Based Services and Solutions for Fortune 1000 clients in a broad range of industries. Core Industries served include: Biotech/Pharmaceutical, Cable, Clinical, Consumer Services, Energy, Engineering, Financial Services, Food & Beverage, Government/Defense, Healthcare, Insurance, Logistics, Manufacturing, Media, Mortgage, Oil & Gas, Pharmaceutical, Retail, Scientific, Services, Technology, Telecommunications, Transportation, and Utilities.
ICONMA is a certified Woman-Owned “Woman-Owned Business Enterprise”, certified by Women’s Business Enterprise National Council (WBENC) and National Women Business Owners Corporation (NWBOC).
The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner.
We measure success by the results of our customers. As a business partner, we know that world-class service and cost effective solutions are the primary keys to success. ICONMA uses technical expertise and business knowledge to help customers achieve these objectives.

Email : ssmith@iconma.com

Tele Phone :(770)658-8033

Toll Free : (855)619-4956