Process Engineer
DUTIES:
Provide knowledge of 21cfr part 210 and part 211 fda governance on pharmaceuticals and vaccines. Provide engineering design deliverables. Review, approve and provide input to project c&q documentation to ensure adherence to corporate policies, industry best practices and project governing documents. Ensure that the execution team follows good manufacturing practices (gmp), good documentation practices and standard operating procedure (sop). Develop user requirement specification (urs), and functional requirement specification (frs). Analyze test scripts to check if it has covered the functionalities of the system as defined in the user requirement specification. Develop p&ids (process flow diagrams) and pfds (process & instrumentation diagrams). Prepare, remediate, and close out deviation reports. Prepare system turnover packages for archival. Support and provide technical leadership in all process design and development efforts. Designing and sizing the various mechanical equipment like air handlers, chillers, heat exchangers, pumps, mixing tanks, filters and other process equipment used in the building in a robust way adopting to the new technologies. Perform design reviews with qa (quality assurance), qc (quality control), operations, and environmental & health safety teams to provide sustainable and quality compliant processes according to standards for gmp (21cfr part 210 and part 211 fda governance on pharmaceuticals and vaccines). Support and supervise the engineering team to facilitate the field execution activities during the construction phase. Provide the routine construction, cost, resource and project completion reports in the construction phase of the project. Develop qualification protocols with the equipment commissioning and qualification (c&q) teams during detailed design, execution, and the validation according to the gmp requirements. Use system for buffer preparation area storage and distribution, clean in place (cip)/steam in place (sip) system, chemical storage and distribution systems, transfer panels, peristaltic pumps, biosafety cabinets and fume hoods.
REQUIREMENTS:
Master's degree or equivalent in Biotechnology Engineering, Pharmaceutical Engineering or related discipline. Candidate must have knowledge of, engineering and construction activities of new facilities as well as expansion of existing facilities to support the clinical manufacturing of pharmaceutical products. Candidate should have understanding of process and equipment design used in biopharmaceutical industries; good manufacturing practices (GMP) and good documentation practices; developing user requirements specifications (URS) and functional requirement specifications (FRS) to design process and equipment for the manufacturing of pharmaceuticals and vaccines; developing P&IDS (Process & Instrumentation Diagrams) and PFDS (Process Flow Diagrams).
JOB LOCATION:
Somerset, NJ. Job may require some travel in the us with expenses paid by employer. 40 hrs per week. Applicant must be authorized to work in the united states.
Send resume to:
370 Campus Dr., Suite 130, Somerset, NJ 08873
OR recruiter@forteedge.com
