7 Yrs Experienced Technical Maintenance And Metrology LAB Manager

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Today we are hiring a Technical Maintenance and Metrology LAB Manager for our client in New Albany OH.

Job Type:

Full Time Experienced

Discipline:

Technical Maintenance & Operations

Required Education:

4 Year Degree

Nature and Scope of this role

The Manager provides leadership and hands on technical support for facility utility lab and manufacturing equipment and associated instruments for all Ohio facilities. Working as part of a multidisciplinary team the Manager will ensure any modification installation preventative maintenance calibration operational support repair or troubleshooting activity is properly staffed and supported in compliance with engineering specifications the Food and Drug Administration (FDA) and Good Manufacturing Practices (GMP) guidelines. The individual will be responsible for providing Subject Matter Expertise (SME) for all aspects of the Maintenance and Metrology programs.

This position requires the ability to lead direct and grow a maintenance department chair meetings present topics to the leadership team provide constant thorough and professional communication throughout all levels of the organization.

Essential Duties and Responsibilities

Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time.

• Manage Preventative Maintenance/Calibration/Repair Program
• Prepare maintain and follow procedures for the maintenance calibration and metrology systems and associated processes to adhere to cGMPs company local and state requirements.
• Maintain review and communicate metrics to all levels of the organization.
• Support efforts to analyze and communicate performance against expectations provide feedback establish and track required actions to improve performance.
• Coordinate shutdown activities and scheduling of calibration/PM/repair work.
• Develop conduct and document test methods for facilities/utilities/HVAC/instrument systems troubleshooting
• Review Calibration/Maintenance Paperwork.
• Evaluate breakdown and calibration statistics and adjust plans to suit.
• Increase overall equipment availability through reduction of breakdowns.
• Monitor equipment operation and implement corrective actions for out of specification operation and alarms.
• Increase overall instrument performance through optimization of calibration activities.
• Monitor instrument calibration results and implement corrective actions for out of specification conditions.
• Optimize spare parts stocking program.
• Assess staffing levels against requirements and production needs.
• Support Quality Assurance investigations of breakdowns and calibration failures.
• Coordinate equipment and instrument breakdown repair activities and serve as customer point of contact.
• Facilitate completion of change control documentation.
• Ensure that equipment files are maintained.
• Ensure that facilities/utilities/HVAC/instrumentation drawings are maintained in asbuilt condition.
• Provide technical troubleshooting support to mechanics/technicians responding to breakdowns.
• Serve as site owner and subject matter expert of Work Order system.
• Develop review revise and maintain SOPs for all equipment utilities and maintenance processes and Metrology/Calibration processes.
• Manage Maintenance/Calibration Supervisors
• Develop training evaluate personnel and provide coaching/feedback to develop/enhance technical personnel capabilities.
• Coordinate Service Providers
• Manage contracts to ensure appropriate service levels at acceptable cost levels.
• Establish agreements to assure coverage of critical systems.
• Oversee technical quality of work performed.
• Ensure that work performed by service providers meets regulatory expectations.
• Coordinate Handover of Equipment from Engineering
• Work with engineering team to review specifications and provide input
• Accept turnover packages and establish maintenance programs.

• Position has responsibilities at multiple locations in central Ohio.

• Provide effective leadership including: individual goal setting/performance reviews managing the development of employees recognizing and appreciating employee contributions mitigating conflict and communication problems planning and facilitating team activities selecting personnel and motivating members of the functional area.
• Perform any other tasks/duties as assigned by management.

Compensation

Base Salary USD $130000 to $170000

Fulltime

Benefits Full

Relocation Assistance Available Possible for ideal candidate

Commission Compensation No

Bonus Eligible No

Overtime Eligible No

Interview Travel Reimbursed No

Candidate Details

7 to 10 years experience

Seniority Level MidSenior

Management Experience Required No

Minimum Education 4 year degree

Willingness to Travel Occasionally

Security Clearance Required: No

Visa Candidate Considered: No

We are seeking candidates with strong leadership have subject matter experience and you have to be super resilient due to the nature of this position.

The schedule:

Mon Fri 6am2pm No Weekends

Bonus will be performance based at 15% of your salary also we offer an incentive plan.

* If sponsorship is needed we will look per case by case scenario due to candidacy industry experience. We are seeking Strong Leadership Subject Matter and Super resilient candidates.

Education Requirements and Qualifications

• Required Qualifications
• High School Diploma or GED equivalent required. Advanced mechanical/electrical training and/or a Technical Associates degree required. Bachelors Degree with a minimum of 5 years experience preferred.
• Minimum 8 years of experience in Pharmaceutical or similar regulated industry.
• Minimum 5 years management experience.
• Experience with calibration systems and metrology strategies and techniques process systems and equipment such as filters pumps tanks mixers autoclaves fillers cappers clean rooms labeling and packaging equipment etc.
• Proficient in the use of Microsoft Office Applications including Microsoft Project Word and Excel.
• Job assignments are complex in nature and require excellent planning project leadership technical skills and communication to be successful in meeting project objectives. The Manager must be able to coordinate and resolve both interpersonal and technical problems and work independently.
• Comfortable working in production environment with multiple priorities. Works effectively as a team member or as a team leader.
• Handson ability to isolate problems and identify root cause of issues.
• Preferred Qualifications
• Ability to teach others how to fix things ability to analyze data to identify trends and establish corrective actions. Understanding of engineering principles as they apply to facility production equipment and scientific instruments. Understanding of Ability to understand mechanical layouts and electrical/pneumatic schematics (P&IDs).
• General knowledge of Plant Utility systems and equipment such as vacuum pumps compressors chillers boilers etc.
• General knowledge of HVAC systems such as air handlers chillers heat exchangers
• Detailed knowledge of Process Control and Instrumentation Systems.
• General knowledge of sanitary piping principles including pipe specification valve configuration pump setup etc.
• Familiar with AutoCad.
• Ability to clearly and concisely express thoughts in written procedures protocols and reports. Ability to write procedures that clearly define required tasks. Ability to proofread others work for accuracy. Ability to generate presentations/reports to explain and/or analyze areas of responsibility.
• Understanding of Continuous Improvement Principles.
• Knowledge of OSHA requirements and understanding of cGMP GDP and FDA requirements as they apply to processing. Experience with regulatory interaction/auditing. Experience with Validation and Investigation Reporting.

Physical Environment and Requirements

• Physically able to wear clean room/protective gowning and equipment including but not limited to gowning goggles face shields and protective gloves.
• PPE is essential for the health and safety of employees.
• Employee must be able to occasionally lift and/or move up to 25 pounds.

Remote Work :

No