Engineering Manager (UKMHRA/USFDA Approved Factory)
Job Description
Title: Engineering Manager (UKMHRA/USFDA Approved Factory)
Company Name: Ziska Pharmaceuticals Ltd.
Vacancy: Not specific
Job Location: Gazipur (Kaliakair)
Employment Status: Full-time
Educational Requirements:
∎ Bachelor's degree in Engineering or a related field. A Master's degree would be a plus
Experience Requirements:
∎ At least 8 year(s)
Job Responsibilities:
∎ Regulatory Compliance: Ensure strict adherence to all relevant regulations and guidelines set forth by the UKMHRA or USFDA, relating to engineering, maintenance, and facility operations within a pharmaceutical manufacturing environment
∎ Engineering Operations Management: Oversee the day-to-day operations of the engineering department, including maintenance, calibration, troubleshooting, and repair of equipment, utilities, and facilities
∎ Team Leadership: Provide effective leadership to a team of engineers and technicians, fostering a collaborative and high-performance work culture. Coach, mentor, and develop team members to enhance their technical skills and overall performance
∎ Equipment Maintenance and Reliability: Develop and implement preventive maintenance programs to ensure the uninterrupted operation of critical equipment and systems. Monitor equipment performance, analyze data, and implement continuous improvement initiatives to enhance reliability and minimize downtime
∎ Capital Projects: Collaborate with cross-functional teams to plan, execute, and manage engineering projects, including equipment upgrades, facility expansions, and process improvements. Ensure projects are completed within budget and on schedule, adhering to regulatory requirements
∎ Risk Management: Identify and assess potential risks related to engineering operations, implement appropriate risk mitigation strategies, and establish contingency plans to minimize operational disruptions
∎ Compliance Documentation: Maintain accurate and up-to-date documentation of all engineering activities, including maintenance records, calibration logs, equipment manuals, and Standard Operating Procedures (SOPs), as required by regulatory agencies
∎ Budgeting and Cost Control: Develop and manage the engineering department budget, ensuring cost-effective utilization of resources while maintaining high-quality standards and regulatory compliance
∎ Vendor and Contractor Management: Collaborate with external vendors, suppliers, and contractors to source equipment, spare parts, and services. Establish and maintain effective relationships while ensuring compliance with relevant regulations and quality standards
Additional Requirements:
∎ Extensive experience (typically 8+ years) in engineering management within the pharmaceutical manufacturing industry, preferably in a UKMHRA or USFDA approved facility.
∎ In-depth knowledge of pharmaceutical manufacturing processes, equipment, and utilities
∎ Strong understanding of relevant regulations, such as Good Manufacturing Practices (GMP), regulatory standards, and guidelines enforced by the UKMHRA or USFDA
∎ Proven leadership abilities with a track record of successfully managing and developing high-performing engineering teams
∎ Experience in executing capital projects, including equipment installation, validation, and commissioning
∎ Excellent analytical, problem-solving, and decision-making skills
∎ Effective communication and interpersonal skills to collaborate with cross-functional teams, regulatory agencies, and external stakeholders
∎ Profcient in using computer-aided engineering (CAE) software and Computerized Maintenance Management Systems (CMMS)
Job Source: Bdjobs.com Online Job Posting.
Application Deadline: 30 Jun 2023
Company Information:
∎ 6 Jun 2023
∎ Ziska Pharmaceuticals Ltd.
∎ Business : Ziska Pharmaceuticals Ltd. takes pride to be one of the finest manufacturing facilities in the country which is fully GMP compliant and built as per USFDA, UKMCA, TGA & ICH guidelines. It has set up a new modern manufacturing facility at Shafipur, Gazipur where the production flow has been separated from molecule to molecule like penicillin, cephalosporin and general formulations.
Category: Engineer/Architect
: Persuasion of any kind will automatically be judged as disqualification
Source: bdjobs.com
Deadline Expired on 30th Jun 2023
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