Sterling Engineering, Inc.
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https://www.sterling-engineering.com
https://www.sterling-engineering.com
USD
115000
140000
YEAR
true
Facilities and Metrology Manager
Farmingdale, NY 11735 US
2023-09-14
2023-10-25
Employment Type:
Permanent
Job Category: Executive/ Management
Job Number: Na837594821
Compensation: $115000-140000 / year
Job Description
Title: Facilities and Metrology Manager
Location: Farmingdale, NY
Hire Type: Direct Hire, Onsite
Target Salary Range: $110,000 - $130,000/year
Overview:
Sterling has helped build careers for thousands for professionals like yourself. Our expert recruiters support you at every step in the process and as a Best of Staffing company, Sterling provides exciting work with exceptional employers across the U.S.
Job Summary:
This position is responsible for managing the Calibration Program. The Calibration Manager is also responsible for following NIST, FDA and other regulatory agencies guidelines in order to meet the compliance aspect of the program and sites. This person will ensure that all scheduled calibrations are performed on time and personnel are able to perform such functions. This position is also responsible of managing all the non GMP facility systems.
Job Duties:
- Manage the Calibration Program ensuring calibration best practices, NIST traceability, adherence to regulatory compliance, updates of SOPs and monitor the program for continuous improvement initiatives.
- Manage the CMMS to ensure that the system manages scheduled and nonscheduled calibration work orders, trends of calibration data, data is up to date and accurate.
- Accountable for the Instrumentation/Calibrations group to assure that required process, laboratories, utilities and facilities equipment calibrations are performed in compliance with NIST, cGMP regulations, company policies and procedures and meet Federal and local governmental regulation (e.g. FDA, EQB, OSHA, etc.).
- Manage service contracts, contractors and preventive maintenance activities on the non GMP facilities including: Fire protection system, fire alarm system, HVAC on the office area, landscaping, sprinkler system, snow removal, cleaning services)
- Manage technicians to support all the corrective work orders throughout the non GMP facility including office area, exterior of the facility, technical areas cleaning maintenance for what concerns cleaning and proper areas presentation.
- Manages departmental budget to ensure area consumables, external services, personnel training, tools and facilities are provided to personnel and areas serviced. Manage projections of expense and controls based in site needs and priorities.
- Responsible for the efficient personnel organization to comply with calibration schedules in alignment with site manufacturing schedule. Provides solution-solving techniques and/or troubleshoots routine and unusual problems.
- Ensures that proper spare parts inventory is available in the stock room and personnel have the necessary skills to complete their tasks (e.g. instrument configuration)
- Manages resources effectively and efficiently within budgetary constraints and evaluates personnel capabilities to provide adequate training.
- Encourage team to create, identify and implement new and innovative ideas/technologies for the successful development of business opportunities within and outside of the Instrumentation/calibrations area.
- Ensures communication forums are available for all employees.
- Facilitates change through creative administrative and technical solutions that are grounded in a realistic assessment of what can be achieved.
- Establish Key Performance Indicators (such as overtime used, Cal Schedule compliance, failure trend, schedule compliance) and provide/execute corrective actions plans
- Perform/Evaluate Change Control, Quality Events and CAPA/Stand Alone action related documentation and instrument performance and ensures its adequacy and on time completion.
- Troubleshoots routine and unusual technical / administrative problems.
- Participates in regulatory audits as SME and assure areas of responsibility readiness in preparation for PAI and other Regulatory Agencies audits.
- Performs performance appraisals to all personnel under his/her responsibilities following company policies and procedures
- Executes performance improvement plans, development and disciplinary actions as required.
- Keeps abreast of reliability principles applicable to site instrumentation and calibration workflow.
- Ensure all work areas are safe and organized based in a 5S program.
- Deals effectively with internal and external sources.
- Review and approval of calibration records.
Qualifications:
- BS in Electrical, computer, Mechanical Engineering, Electronics, equivalent degree or equivalent experience.
- Eight (8) years’ experience in instrumentation technology for processing, laboratories, utilities and facilities equipment in a pharmaceutical manufacturing environment.
- Five (5) years’ experience in a supervisory role in a pharmaceutical environment.
- Knowledge of cGMP’s, local/Federal regulatory requirements, and documentation procedures pertaining to a biopharmaceutical manufacturing plant.
- Timely and effective decision making, and timely conflicts resolution skills.
- Ability to organize and prioritize workload and meet deadlines in a highly technical and rapidly changing environment.
- Ability to troubleshoot problems for highly technical equipment.
- Computer literate with the ability to understand and use basic computer software packages like Excel, Word, Power Point, Internet, CMMS, etc.
- Ability to read and interpret complex mechanical, pneumatic and electrical blueprints.
- General knowledge in automated equipment functionality and architecture.
- Strong interpersonal relationship skills with subordinates, peers, management and clients.
- In-depth knowledge in the design, installation, commissioning and validation/qualification of equipment/instruments as applied to pharmaceutical production environment.
- Experience with external and internal regulatory audits (FDA, EMEA, etc.)
- Knowledge of mechanical concepts, electrical controls theory and electronic circuitry.
- Able to read, interpret, and understand electrical/mechanical drawings and instrument installation requirements.
- Good technical writing skills and ability to review SOPs and work instructions.
- Significant abilities and aptitude to analyze data detecting inconsistencies, determining relative importance and to solve complex technical situations based on data.
Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.
