Specialist, CTU Engineer

Job Description

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!

The Controlled Temperature Unit (CTU) Specialist is an individual contributor.

ACCOUNTABILITY

Under the supervision of a Senior Specialist or Associate Director, this individual is responsible to provide day-to-day equipment and facility engineering support for CTUs across the site. Actively ensures compliance to current Good Manufacturing Practices, Safety, and Environmental regulations while achieving operating cost goals.

Assigned tasks may include:

• Support and monitoring of equipment performance

• Equipment maintenance

• Developing equipment and facility improvement plan

• Troubleshooting process equipment to ensure reliable, compliant and efficient operations.

• Execution of equipment lock-out tag-out (LOTO)

DUTIES

• Provides day-to-day shop floor equipment, instrumentation, robotic & utilities engineering support to manufacturing operations.

• Assists/leads operations, maintenance supervisors, mechanics, automation engineers, process engineers and Quality representatives in troubleshooting equipment problems as well as investigating manufacturing atypical events related to system failure or malfunction.

• Ensures adequate spare parts inventory.

• Assists in the facilitation of maintenance work, including leading JSA/LOTO execution, directing mechanic labor, and identifying spare parts.

• Responsible for ensuring CMMS/EAM data is up to date and accurate for their assigned equipment.

• Provides technical assistance in the maintenance planning process.

• Optimizes and coordinates scheduling of preventative, predictive & corrective maintenance to improve equipment reliability.

• Develops and maintains metrics used to run the business. Communicates and presents metrics/reports regularly.

• Champions the preventive and predictive maintenance program within your area of responsibility, reviews equipment history for reliability concerns, performs root cause analysis, and identifies reliability improvement opportunities and applications for predictive maintenance technologies to reduce maintenance costs. Develops maintenance and repair strategy for bi-annual shutdowns.

• Works with Operations, other EM&U engineers, Technology, Maintenance Supervisors and mechanics to maximize capacity and assure efficient, reliable equipment operation in accordance with all GMP, safety and environmental regulations. Collaborate with operations for day to day priorities, maintenance scheduling, deviation management, etc. Effectively influences and collaborates with stakeholders and partners outside of their immediate organization.

• Provides supervisory coverage when required.

• Promotes open communications and team work.

• Maintains a high level of technical knowledge and may coordinate safety, current Good Manufacturing Practices, and environmental compliance programs.

• Actively supports productivity improvement program and resolution of deviation events. Participates in root cause investigations.

• Evaluates, develops and improves business processes and develops technical rationale for system improvements.

• Develops Qualification, SOP and Preventative Maintenance documentation and provides reports, data and information to support on-going operations.
• Serves as the project engineer and manager for projects including scope development, design support, field execution and commissioning/qualification testing.

• Develops strong relationships with site operations to ensure consensus on operational and regulatory compliance issues.

• Explains and enforces all GMPs, safety, and environmental regulations.

• Assist in audits, regulatory inspections and training in the area of responsibility.

• Authors Standard Operating Procedures or User Manuals and assists in training development for mechanics and supervisors.

• Assists in the preparation of process studies, engineering standards, equipment utilization, and profit plan.

QUALIFICATIONS:

Essential:

• B.S. Engineering, Science, or 4 Year Engineering Technology Degree.

• Minimum of two (2) years of relevant work experience, including:

• Equipment troubleshooting

• Facilitating work execution

• Identifying and executing continuous improvement projects

• Maintenance data management/improvement

• LOTO

• Demonstrated ability to work independently and as part of a team.

• Proficient in the following competencies: empowering leadership, flexibility, motivation, teamwork/collaboration, problem-solving, communication, and computer skills.

• Knowledge in the application of engineering standards (i.e. ASME, IEEE, NFPA, CFR 1910, NIST, and/or ANSI).

Preferred:

• Knowledge of cGMP for pharmaceutical and/or vaccine manufacturing

• CTU maintenance and troubleshooting experience

• Lean Six Sigma Methodology

• Root Cause Analysis

• Failure Mode Effects Analysis

• Knowledge in reliability engineering (including asset life cycle management)

• Computerized Management Maintenance Systems: SAP/EAM/Maximo/etc.

• CMRP certification

VETJOBS

…