Senior Validation Engineer, Facilities & Equipment

Employer
Fahrenheit IT
Location
Salisbury, MD
Posted
Feb 21, 2019
Closes
Feb 22, 2019
Function
Engineer
Hours
Full Time
Full Description: Our client, a global generic pharmaceutical company providing new and advanced products are devoted to discovery, manufacture, sale and distribution of prescription generic pharmaceutical products has an excellent opportunity for Senior Validation Engineer, Facilities & Equipment to work in Salisbury, MD office. The individual MUST have the ability to hit the ground running (after a brief 1-2 day training period). This is a full-time (40 hour per week) on-site contract opportunities based on W2/1099/Corp-to-Corp. If you are interested in aligning with a highly regarded organization that values quality and integrity and fosters an environment where teamwork and professionalism thrive, then don't hesitate to contact us at rchugesnetwork.com or and call Rose Chu, VP in Pharmaceutical & Biotech Services Group at 610-822-1256 for questions. We are always interested in talking to candidates for current AND future opportunities Please respond directly to Global Employment Solutions, Inc. at rchugesnetwork.com with your resume attached -WORD document. Sr. Validation Engineer resource Under the direction of the Sr. Manager, Validation-Facilities & Equipment: Supporting the validation program associated with manufacturing and facility related GMP critical and non-critical equipment and systems. Ensures that all department responsibilities are performed and documented accurately, timely and in compliance with SOPs, GDPs, cGMPs and FDA requirements. Where required, as per the assigned projects: Assists and coordinates equipment and utility qualifications. Assume responsibility for multiple projects simultaneously. Develops critical validation lifecycle documentation to support the qualification/validation of equipment and utilities (eg IQ, OQ and PQ protocols, Operational SOPs, PMs). Executes equipment qualification protocols and accurately documents results of the defined testing; then comparing and reporting those results to predefined/approved acceptance criteria. Organizes and presents qualification data, results, documentation and reports within the appropriate equipment/system validation files and system manuals. Creates, maintains and reports progress against validation project schedules. Maintains highly detailed activity records for the purposes of project tracking and costing. Collects and organizes technical specifications, data and information required for capital/construction projects. Coordinates start-up and training for new equipment installation. Develops URS and detailed technical specifications for manufacturing, packaging and utility equipment. The following projects are currently in process, and the individual may be assigned to lead or assist in one or several of the projects. Therefore, the individual will need to have experience with the following (higher priority given to the items higher in the list): Server / Storage Area Network Change Control for Serialization and Blue Mountain Systems New Tablet Coater New air compressor, dryer, and air storage tank. New Purified Water System Tablet testers (3) qualification New Blister and Cartoner Packaging Line New Chilsonator / Roller Compactor with integrated auto-recirculation and sifting. Product elevator for above roller compactor. Packaging Line Performance Qualification INDUSTRY EXPERIENCE REQUIRED Eight (8) to Ten (10) years of validation / qualification and project management experience in a pharmaceutical environment. Minimum of Five (5) years validation / qualification experience in an Oral Solid Dosage Environment. Strong understanding of cGMPs, FDA, OSHA, and other local, state and federal regulatory requirements associated with pharmaceutical manufacturing facilities and associated equipment. Keywords: Sr. Validation Engineer, Senior Validation Engineer, Facilities & Equipment , Pharmaceutical Validation Engineer, Senior Quality Validation engineer, Validation-Facilities & Equipment, validation program associated with manufacturing and facility, GMP, SOPs, GDPs, cGMPs, FDA. equipment and utility qualifications, validation lifecycle documentation, qualification/validation of equipment and utilities, IQ, OQ and PQ protocols, Operational SOPs, PMs; equipment qualification protocols, equipment/system validation files and system manuals, Develops URS, specifications for manufacturing, packaging and utility equipment, Change Control for Serialization and Blue Mountain Systems, New Tablet Coater, New air compressor, dryer, and air storage tank, New Purified Water System, Tablet testers qualification, New Blister and Cartoner Packaging Line, New Chilsonator / Roller Compactor with integrated auto-recirculation and sifting, Product elevator for above roller compactor, Packaging Line Performance Qualification, validation / qualification, pharmaceutical, validation / qualification, Oral Solid Dosage, cGMPs, FDA, OSHA, pharmaceutical manufacturing facilities and associated equipment We appreciate your understanding, in that; we will only be able to respond to those inquiries who meet the stated requirements. To protect our client's interests, we will not be responding to inquiries that do not contain a CV/Resume. Finally, please include the position ID (rc-Sr. Pharma Validation) in the subject line of your correspondence to ensure review. Please forward your credentials in Word format, in confidence, to: rchugesnetwork.com Our clinical recruiter/manager will contact the qualified candidates IMMEDIATELY to set up interviews. Rose Chu Vice President - Pharmaceutical, CRO, Biotech, Medical Device Global Employment Solutions/Fahrenheit IT P (610)822-1256 | C (215)-317-2999 | F (610-668-5000) | rchugesnetwork.com One Presidential Blvd. North, Suite 310, Bala Cynwyd, PA 19004 We're looking for hot talent Tell your friends and get $250 plus ID: 164958 - provided by Dice Costing, FDA, Lifecycle, Manager, Management, Medical Device, Packaging, Project, Project Management, Protocols, Recruiter, Testing, Validation

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