PharmEng Technology is a full service consulting firm that serves the pharmaceutical, medical devices and biotechnology industries in North America and internationally. Since 1997, the company has provided industry recognized consulting services assisting clients in the rapid commercialization of new product from drug discovery, strategic planning to process scale up.
PharmEng technology has immediate opening for Calibration/Metrology Manager with experience in pharmaceutical/biotechnology industry
- Manage financial budget and forecasts for company calibration program.
- Measure, review and provide reports on calibration program.
- Manage and administer the Calibration Management System (CMS) database
- Validate accuracy of documentation and records (ie. calibration and SOPs, instrument service records, customer files and training)
- Lead technical support or specialist in service, calibration, validation, and support of instruments.
- Provide technical expertise, training, and engineering support to technicians, associates, and customers.
- Monitor and report on vendor performance.
- Review and approve service records and reports (ie. certificates of calibration, executed protocols, work orders and vendor reports, for completeness and accuracy).
- Develop and maintain department quality control systems and operational procedures to ensure accuracy in analyses, measurement and testing standards
- Seek to effectively understand customers’ needs to ensure that expectations are being met.
- Review and inspect of the Metrology/Calibration program for compliance with established requirements.
- Assure that management and QA are informed of compliance status and adherence to commitments.
- Identify, recommend, initiate and direct improvements of the department quality program.
- Participate in, and act as liaison for, internal and external inspectors of department.
- Identify, solicit, interview, evaluate and hire qualified staff.
- Demonstrate safety knowledge, awareness and compliance with all safety and other job related policies, procedures and other.
- Maintain personal technical expertise (ie. scientific meetings, in-house and external training courses, and other developmental opportunities).
- Actively participate in workplace safety and quality audits, and in other corporate and departmental programs or initiatives.
- Recommend use of qualified outside resources in support of projects.
- Has signature authority, within defined Delegation of Authority, to spend moneys to repair and support instruments.
- Act independently in accordance with broadly defined functional policies and precedents, general leadership direction, leadership principles, budgetary guidelines, company policies, values, ethics and applicable law.
- Exercise discretion in determining appropriate plans, priorities, processes and/or courses of action required to achieve business goals, objectives, solutions and results.
- Degree or diploma in a technical discipline
- Experience in pharmaceutical/biotechnology industry-Minimum of 7-10years
- Demonstrated skills in leading a team, project management and planning
- Ability to complete service with limited resources and in a timely manner
- Excellent verbal and written communication skills
- Proficient use of computers and applications
- Competence in reading and preparing technical documents and records
- Manual dexterity to manipulate and service equipment
- Experience and/or understanding of calibration, qualification and validation activities
- Familiarity with Calibration Programs such as Procal and Maximo is an asset
Willingness and ability to Travel. Hold a valid driving license and passport. Must be able to legally work in North America and Europe.
Indeed - 2 years ago