Career / Internship
Project Engineer
This position is responsible for the safe and effective development, design, and implementation of assigned capital projects that are completed on time, on or below budget, with an end result that is fit for its intended purpose. Essential considerations are given to safety, quality, operability, processing efficiency, maintainability, and environmental compliance. This position will also include participation in troubleshooting efforts, operation process support, and continuous improvement.
Key Responsibilities
Manage projects from initial concept development to mechanical completion and commissioning/qualification of new or modified process and utility equipment installations. Provide project/equipment engineering support and troubleshooting necessary to meet all production/customer requirements. Prepare comprehensive Business Case Justifications and Requests for Proposals for capital projects. Manage outside contractors who are employed to complete projects within agreed-upon timelines and budgets. Provide adequate training for operating personnel for new and modified equipment in order to improve safety and operational efficiencies. Initiate studies and develop proposals to the Facilities Manager for process and/or equipment modifications, replacements, or additions in support of more efficient manufacturing or supporting systems operation. Carry out any other duties which are within the employee’s skills and abilities whenever reasonably instructed.
Qualifications
Bachelor’s degree in chemical or mechanical engineering or equivalent degree (Essential). 1-5 years or more of experience in the fields of project design and construction with project management experience in the pharmaceutical industry or similar experience (Preferred). Experience with and a thorough understanding of technical concepts, practices and procedures in bulk pharmaceutical manufacturing, and related support systems (Preferred).
Personal Skills and Key Competencies
Experience working with Microsoft Office Products: Outlook, Word, Excel, Project & Visio (Essential). Ability to read and understand repair manuals, specifications, drawings, & schematic diagrams (Essential). Excellent communication & interpersonal skills (Essential). Excellent organizational skills & detail-oriented (Essential). Good technical writing skills (Essential). Must be able to work independently with minimal supervision (Essential). Lean/Six Sigma Experience (Preferred). Ability to modify and update drawings in AutoCAD (Preferred).
Key Responsibilities
Manage projects from initial concept development to mechanical completion and commissioning/qualification of new or modified process and utility equipment installations. Provide project/equipment engineering support and troubleshooting necessary to meet all production/customer requirements. Prepare comprehensive Business Case Justifications and Requests for Proposals for capital projects. Manage outside contractors who are employed to complete projects within agreed-upon timelines and budgets. Provide adequate training for operating personnel for new and modified equipment in order to improve safety and operational efficiencies. Initiate studies and develop proposals to the Facilities Manager for process and/or equipment modifications, replacements, or additions in support of more efficient manufacturing or supporting systems operation. Carry out any other duties which are within the employee’s skills and abilities whenever reasonably instructed.
Qualifications
Bachelor’s degree in chemical or mechanical engineering or equivalent degree (Essential). 1-5 years or more of experience in the fields of project design and construction with project management experience in the pharmaceutical industry or similar experience (Preferred). Experience with and a thorough understanding of technical concepts, practices and procedures in bulk pharmaceutical manufacturing, and related support systems (Preferred).
Personal Skills and Key Competencies
Experience working with Microsoft Office Products: Outlook, Word, Excel, Project & Visio (Essential). Ability to read and understand repair manuals, specifications, drawings, & schematic diagrams (Essential). Excellent communication & interpersonal skills (Essential). Excellent organizational skills & detail-oriented (Essential). Good technical writing skills (Essential). Must be able to work independently with minimal supervision (Essential). Lean/Six Sigma Experience (Preferred). Ability to modify and update drawings in AutoCAD (Preferred).
Senior Compliance Specialist
Responsible for the design, development, qualification, validation, and implementation of analytical procedures in support of research, GMP production, and stability testing. The Analytical Scientist is expected to provide quality ideas and contribution to the assigned challenges; mentors junior analysts and offers recommendations and knowledge to other staff.
Key Responsibilities
Performs Quality review of equipment installation, operation, and performance qualification protocols. Qualifications will be for production equipment (reactors, filters, ovens, etc), analytical instrumentation (HPLC/UPLC, GC, etc) and site utilities (HVAC, Purified Water, Nitrogen, etc). Performs Quality approval of executed equipment qualification protocols. Provides oversight of Supplier Management program. Ensures that required activities are completed Assists in gathering site Key Performance Indicators (KPIs). Provide audit assistance for regulatory inspections and routine customer audits. Assists management will providing responses and CAPAs to audit observations. Works with other departments to develop and implement various trainings. Provides oversight and performs internal audits. Works on compliance related deviations/investigations, CAPAs and Changes as either owner or QA oversight. Special Factors Predominately in office environment. Occasional walking, standing for long periods of time while in labs/plant, kneeling, reaching, handling, twisting, and bending spine at waist when filing or operating office/lab equipment. Moderate travel may be necessary for technical meetings, customer visits/audits, and supplier contacts. Qualifications BS in a scientific discipline or equivalent with a 6+ years’ experience in an FDA regulated industry. MS in a scientific discipline or equivalent with a 5+ years’ experience in an FDA regulated industry. Experience with Quality Assurance oversight. Demonstrate confidence in knowledge of Good Manufacturing Practice (GMP) regulations. Knowledge and previous experience with GMP, ICH Q7, and 21 CFR Part 11. Good understanding in one or more of the following areas: Quality systems, Analytical, Regulatory, Qualifications, Environmental monitoring, supplier management. Expertise in FDA regulations, GMPs, and Quality Systems relevant to the manufacture of pharmaceuticals. Experience mentoring and training staff members in a Quality department. Experience with Microsoft Office and other complex computer software Experience with commercial phase pharmaceuticals EMEA experience Personal Skills & Key Competencies Demonstrate attention-to-detail, problem solving, and ability to make decisions quickly. Excellent analytical, written and verbal communication and presentation skills. Strong technical writing skills and the ability to clearly express ideas in English. Ability to work independently and in a team environment Ability to positively resolve conflict Flexibility for changes in work priorities
Key Responsibilities
Performs Quality review of equipment installation, operation, and performance qualification protocols. Qualifications will be for production equipment (reactors, filters, ovens, etc), analytical instrumentation (HPLC/UPLC, GC, etc) and site utilities (HVAC, Purified Water, Nitrogen, etc). Performs Quality approval of executed equipment qualification protocols. Provides oversight of Supplier Management program. Ensures that required activities are completed Assists in gathering site Key Performance Indicators (KPIs). Provide audit assistance for regulatory inspections and routine customer audits. Assists management will providing responses and CAPAs to audit observations. Works with other departments to develop and implement various trainings. Provides oversight and performs internal audits. Works on compliance related deviations/investigations, CAPAs and Changes as either owner or QA oversight. Special Factors Predominately in office environment. Occasional walking, standing for long periods of time while in labs/plant, kneeling, reaching, handling, twisting, and bending spine at waist when filing or operating office/lab equipment. Moderate travel may be necessary for technical meetings, customer visits/audits, and supplier contacts. Qualifications BS in a scientific discipline or equivalent with a 6+ years’ experience in an FDA regulated industry. MS in a scientific discipline or equivalent with a 5+ years’ experience in an FDA regulated industry. Experience with Quality Assurance oversight. Demonstrate confidence in knowledge of Good Manufacturing Practice (GMP) regulations. Knowledge and previous experience with GMP, ICH Q7, and 21 CFR Part 11. Good understanding in one or more of the following areas: Quality systems, Analytical, Regulatory, Qualifications, Environmental monitoring, supplier management. Expertise in FDA regulations, GMPs, and Quality Systems relevant to the manufacture of pharmaceuticals. Experience mentoring and training staff members in a Quality department. Experience with Microsoft Office and other complex computer software Experience with commercial phase pharmaceuticals EMEA experience Personal Skills & Key Competencies Demonstrate attention-to-detail, problem solving, and ability to make decisions quickly. Excellent analytical, written and verbal communication and presentation skills. Strong technical writing skills and the ability to clearly express ideas in English. Ability to work independently and in a team environment Ability to positively resolve conflict Flexibility for changes in work priorities
For More Details Contact Us!
Explore our current job openings to find the opportunity that aligns with your skills and career goals. Whether you’re interested in research and development, manufacturing, quality assurance, sales, or other areas of the pharmaceutical industry, we have a place for you on our team.
hr.sanjarpharma@gmail.com
+919512100714
