Pharmatek

Hello Connections! Pharmatek is actively hiring for CQV – Lab Equipment Qualification Engineer at Indianapolis, IN. Responsibilities:   Lead a Team through the qualification effort of making a lab and its equipment compliant to regulations and company procedures • Manage the validation and documentation related to complex computer systems, multiple pieces of equipment/large upgrades/extensive product updates • Perform functions of validation engineer – draft Validation Plans, Requirements, Test Cases, Summary Reports • Manage the systems and processes for change control and coordinate evaluation of proposed changes on laboratory equipment. • Change management process owner for validation involving new or modified equipment, processes, procedures, and products. In this role, validation engineers design and perform validation around lab equipment and computer systems. • Determine and delegate tasks amongst a team to complete assignment. • Conduct impact analysis for validation and change management • Coordinate teams to complete validation testing activities • Manage complete document management and approval through client’s process • Conducts regulatory impact analysis/assessment and, where warranted, makes recommendations. • Act as the Subject Matter Expert on various pieces of lab equipment Requirements • A minimum of a Bachelor’s degree in an Engineering or Scientific degree and five to ten years industry experience. Preferred: • 7+ years’ experience in GMP regulated environment (with Internship or co-op work experience considered as part of that experience) • Direct experience authoring/editing/executing validation documents for laboratory equipment (Cat. A, B &C) • Expert knowledge of FDA regulations, ISPE guidelines and ISO standards including: • Good Documentation Practice (GDP) in the pharmaceutical environment • 21 CFR Part 11 Interested candidates apply here: https://lnkd.in/deuY2nFf #CQV #medicaldevice #pharmaceutical #manufacturing

Hello Connections! Pharmatek is actively hiring for Senior CQV Engineer at Austin, TX. What You’ll Do You will be responsible for performing quality oversight & approval of validations, change controls, records, & projects to ensure consistent deliver of high quality documents, processes, products, and processes. MAIN PURPOSE OF ROLE This position is responsible for providing quality support and oversight on product, process, and equipment related changes and implementations (validation & change control). QUALIFICATIONS Education Level Major/Field of Study OR Education Level Bachelor's Degree in Engineering or Technical Field or an equivalent combination of education and work experience   EXPERIENCE Minimum 5 years experience in medical device/pharmaceutical manufacturing Process Validation experience and demonstrated use of Quality tools/methodologies. Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971. Interested candidates apply here: https://lnkd.in/gh-vv7Ps #CQV #medicaldevice #pharmaceutical #manufacturing

Hello Connections! Pharmatek is actively hiring for Computer Systems Validation (CSV) - SME. CSV SME to act as a reviewer for validation protocols (to include Data Integrity and periodic review) and documentation to ensure protocol accuracy essentially acting as a QAV resource. Experience with the following platforms: DeltaV, Unicorn, BMRAM, MODA, standalone skids, etc. Interested candidates apply here: https://lnkd.in/gbaHc7MA #SME #CSV #texas #opentowork #hiring

Hello Connections! Pharmatek is actively hiring for Construction Safety Program Manager. Candidates with working experience in Pharmaceutical, Medical device, Life sciences and Manufacturing environments such as GMP, cGMP are accepted. Mainly looking for Construction and Safety manager Location: Onsite at Ohio Contract – 6 months Interested candidates apply here: https://lnkd.in/gDWPFi-D #construction #safety #manager #unitedstatesjob #ohiojobs #opentowork #hiring

Hello LinkedIn Connection! Pharmatek is Hiring for Lead Quality/GxP Auditor at Cincinnati, OH. Providing employment benefits and stability in otherwise turbulent times. Excellent role with earning potential! Requirements: ➡️ Minimum 3 years of GxP auditing experience in related industry ➡️ Minimum of 5 years of experience within Pharmaceutical / Biotech / Medical Device industry ➡️ Experience working in a GxP (regulated) environment. ➡️ Experience in technical writing ➡️ B.S./B.A. in scientific discipline as a minimum Please share me your CV at: ➡️ sushmita.v@consultpharmatek.com Apply for the job here: https://lnkd.in/gJtBQar5 *NOTE: Applicants must be eligible to work full-time in the United States with a valid work Visa.* #urgentrequirement #hiring #opentowork #Pharmaclient #audit #gxp Raghu Rajagopal