Validation Engineer

Industry

Pharmaceuticals

Advert ID

FOX_BBBH11710

Location

Monroe

Job Type

Permanent

Hours

Full-Time

Salary Range

Up to USD100000.00 per year

No. of Openings

1

Branch Information

Manpower Engineering , Phone :

ContactNumber

Job Description

Key Responsibilities



The position requires knowledge of cGMP and associated industry and regulatory guidance documents. The candidate must have demonstrated proficiency in project management skills and must be able to balance multiple priorities. Main responsibilities include:



Equipment Qualification - development of validation protocols, testing execution and writes validation reports. This includes FATs, URSs, DQs, SATs, CTPs, IQs, OQs, PQs, and other validation life cycle document.



Cleaning and Process Validation assists/performs cleaning and process validation at the site.



Adhere to all company and GMP procedures, along with safety regulations within the plant.



Assist with the Site Change Management Program to keep all finished products, equipment, processes and facilities in compliance with contemporary industry standards and regulatory filings.



Develop a strong documentation package, involving pre-commissioning/commissioning of equipment, Qualification and documentation



Conduct regular project review meetings within the team, with cross functional teams and with the vendors to control the project time to time.



Stay current with industry qualification trends through FDA, ISPE, EU, PDA and bench marked companies.



Education



Bachelors degree required, preferably in Engineering, Chemistry, Microbiology, or Pharmaceutical Sciences



A combination of education and relevant experience will be considered.



Experience



Minimum of eight (8) years of relevant validation experience in the pharmaceutical industry.



Demonstrated experience and a high level of experience validating a wide range of equipment and processes in Sterile production environments (cleaning processes, sterile filling, freeze drying, depyrogenation, parts & vial washers, wet/steam/dry heat sterilization, pre-filled syringe filling, vial filling, Nebulizer filling, and packaging).



Demonstrated working knowledge of FDA and CFR regulations, and other applicable industry regulations and standards



Demonstrated experience and knowledge of qualifying changes to validated systems/processes/and equipment.



Strong Knowledge and understanding of validation and qualification principles, and Quality Systems principles (Change Control, Non-Conformance and CAPA).



A solid base and application experience in sterile pharmaceutical manufacturing plants, and/or related environmental projects, material handling, containment, and utility/infrastructure support facilities.



Demonstrated ability to effectively communicate and collaborate across all levels of the organization including with customers, vendors, equipment suppliers, and Operations staff.



Strong understanding of aseptic techniques, gowning techniques, assembly of aseptic processing lines and room classifications is required.