Instrumentation and Calibration Engineer

POSITION SUMMARY

The Instrumentation and Calibration Engineer has the responsibility for ensuring the site's production instruments are operating at optimal levels and properly maintained to data collection in an FDA regulated environment. The position will be primarily responsible for ensuring all instruments are maintained in a calibrated state. Additionally, the Engineer will support general troubleshooting of production equipment/utilities, and asset management. To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required: Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices. Consistent support and practice of all Piramal Pharma Solutions mission, vision, and values. Identify and protect the original technical information as part of the company property. Key responsibilities. Support the Preventive Maintenance (PM) program through the creation of new PM tasks, evaluation of existing PMs for technical relevance to current asset problems. Help create Standard Operating Procedures (SOPs) for equipment operation, engineering analyses, PM and calibration tasks, that adhere to FDA and cGMP requirements. Support the management of the calibrations on production instruments, such as temperature sensors (RTDs/resistance thermometers), pressure sensors (electronic manometers, gauges), and other transmitters. Support root cause investigations to a detailed level required for an FDA regulated/cGMP environment, and translate these root causes to effective CAPAs that mitigate equipment risk. Assesses and monitors equipment for reliability of operation implementing necessary improvements Maintains system classification of incoming equipment with the system owner. Duties may include assembly of supplier operating and maintenance manuals, installation and operational qualification. Translate data from Root Cause Centered Maintenance (RCCM) data to support Autonomous Maintenance program. Train Operations personnel in Autonomous Maintenance. Maintain calibration records, and qualification of calibration contractor. Manages risk to achieve organization's strategic objectives in areas of environmental health and safety, asset capability, quality, and production. Conducts risk analyses routinely when production equipment is functioning outside of expected parameters Develops Total Cost of Ownership, Mean Time to Failure, Life Cycle Cost, Mean Time to Repair, specific to critical equipment in the production areas. Runs process improvement projects from design thru implementation. Apply Root Cause Centered Maintenance (RCCM) to develop improved preventive maintenance tasks. Executes changes through to completion, from initiation of change controls to revising SWIs, coordinating work with Maintenance/Engineering, etc., to close out of CCs Collaborates with other departments to ensure that reliability is integrated into all aspects of the organization Participates in and execute qualification and validation of equipment and processes

EDUCATION/EXPERIENCE.

Bachelor's degree in an engineering discipline and 3 years of experience in a related or similar field, or Associate's degree in an engineering or scientific discipline and at least 5 years of experience. Job Competencies.

Analytical thinking:

the ability to think critically and logically, as well as the ability to work with large sets of data and make sense of them.

Technical aptitude:

a strong understanding of the systems, equipment, and processes at hand. This includes knowledge of the engineering principles and specific systems used at an organization.

Mechanical aptitude:

an understanding of how mechanical components fit together and support the function of equipment. Demonstrated curiosity for how production equipment functions.

Problem-solving:

the ability to think creatively and come up with innovative solutions to complex problems. Specific experience applying Root Cause Analysis and Root Cause Investigation concepts to determine root causes and create effective corrective actions.

Communication:

the ability to explain technical concepts in a clear and understandable manner, as well as the ability to collaborate effectively with others. The ability to generate highly technical equipment maintenance into work instructions for Maintenance Technicians.

Time management:

the ability to manage multiple projects and tasks simultaneously and effectively including planning, scheduling, and organizing. Preferred experience in the Agile Project Management System.

A continuous improvement mindset:

identifying and implementing ways to continuously improve reliability. An understanding of lean manufacturing principles, and applying Six Sigma concepts to chemical manufacturing.

Safety-conscious:

the ability to identify potential hazards and take the necessary steps to mitigate them. Knowledge of CMMS system and functions Knowledge of the regulations and their application to instruments that gather GMP data in a production environment. Job Conditions. The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical Demands:

Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected. Long periods of standing and walking can be expected in this position. This position may require long periods of sitting, typing, computer entry or looking at a computer.

Work Environment:

Piramal Pharma Solutions is engaged in the business of pharmaceutical research and contract pharmaceutical manufacturing. As such, all PPS staff work in or nearby either chemical/pharmaceutical research or chemical/pharmaceutical manufacturing equipment and processes. Potential limited exposure to hazardous chemicals. Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position.

ABOUT US

In August 2016, Ash Stevens, Inc. was acquired by Piramal Pharma Solutions (PPS), a world leader in pharmaceutical manufacturing. In partnering with Piramal Pharma Solutions, Ash Stevens rounds out an on-going effort to offer strategic partnerships and a total solutions approach to our customers. PPS has three North American locations - a sterile injectable facility in Lexington, Kentucky; a complex, high value API facility in Toronto, Canada, and Ash Stevens, LLC (D.B.A. PPS-Riverview), a high-potency API facility, located in Riverview, Michigan. PPS-Riverview is a full-service pharmaceutical contract manufacturer (CMO) offering comprehensive small-molecule drug substance development and cGMP manufacturing services of active pharmaceutical ingredients (APIs). With over five decades of experience, PPS-Riverview is committed to providing the highest quality of service and delivering on time, and on budget. PPS-Riverview has extensive experience developing and manufacturing APIs for Life Science companies developing innovator small-molecule therapeutics. PPS-Riverview is a long-time provider of contract research services to the National Institutes of Health and the National Cancer Institute, and has participated in the development of many important drugs through these government agencies. To date, PPS-Riverview has received fourteen FDA manufacturing approvals for innovator APIs, including a number of fast-track manufacturing approvals for the active ingredients for the oncology drugs Velcade®, Vidaza®, Clolar® and Iclusig®. Services offered by PPS-Riverview include process development and scale-up; cGMP manufacturing; development and cGMP manufacture of highly potent APIs using barrier-isolation technology; comprehensive analytical capabilities (including method development, stability studies and qualification of reference standards); and regulatory support for all phases of drug development and manufacturing.

Pay:

$100,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Health savings account Life insurance Paid time off Vision insurance

Work Location:

In person