Off-Shift Associate Specialist, Engineering, Maintenance & Utilities

Job Description

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

Our Engineers support internal and external manufacturing operations to remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. 

The Associate Specialist is an entry-level, or early career, individual contributor.

Under the supervision of a Senior Specialist or Associate Director, is responsible to provide day-to-day equipment and facility engineering support for assigned area including vaccine bulk manufacturing, and/or associated facility/utilities mechanical support. Assigned tasks include support and monitoring of equipment performance and maintenance, propose & develop equipment and facility improvements and troubleshoot process equipment to ensure reliable, compliant and efficient operations. Actively ensures compliance to current Good Manufacturing Practices, Safety, and Environmental regulations while achieving operating cost goals.

DUTIES:

• Reports to and receives supervision from a Senior Specialist or Associate Director. On routine process operations, is guided by standard operating procedures.
• Provides shop floor day-to-day equipment / instrumentation / robotic & utilities engineering support to manufacturing operations.
• Ensures adequate spare parts inventory, optimizes & coordinates scheduling of preventative, predictive & corrective maintenance to improve equipment reliability.
• Interacts with hourly, salaried and contract employees in routine matters, troubleshooting equipment and automation systems.
• Provides supervisory coverage when required. Assists in the training of hourly employees. Promotes open communications and teamwork.
• 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. Executes projects from concept to qualification, which may involve facilities, utilities, equipment, automation, or process related upgrades based on project requirements and site procedures.
• Summarizes project progress, delays, or improvement opportunities. Frequently communicates with immediate supervisor about status of projects or assignments.
• Develops strong relationships with site operations to ensure consensus on operational and regulatory compliance issues.
• Supports regulatory agency inspections.

Education Minimum Requirement:

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

Required Experience and Skills:

• Minimum one (1) year of cGMP, technical/mechanical services experience.
• Good interpersonal skills including flexibility and ability to work in a team environment.
• Good analytical abilities, organizational skills, written and verbal communication skills.

Preferred Experience and Skills:

• Troubleshooting manufacturing equipment, cGMP, and maintenance services experience preferre

Note: This description is not intended to be all-inclusive or a limitation of the duties of the Job. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your