NIGHTSHIFT Automation / Maintenance Technician

MCA Services and MCA Engineering; Durham (NC); On-site; USD 108,000 - 145,000; Full time

Benefits offered by this job

PTO

Paid Holidays

401k Match

Health Plan

Dental

Job summary

MCA Services is seeking motivated automation engineers to join our central and eastern North Carolina team, within 1.5 hours of Raleigh. You will support the design, maintenance, and automation of pharmaceutical manufacturing processes, helping to ensure compliant and efficient operations.

You will work on qualification activities, implement changes, troubleshoot equipment, and maintain GMP documentation, including creating electronic tickets for issues.

Qualifications

• BS degree in engineering, manufacturing technology or related field.
• Strong automation knowledge in pharma processes and equipment.
• Experience with qualified automation and validation preferred.

Responsibilities

• Provide maintenance and automation troubleshooting for new and existing systems during qualification and daily production.
• Design and implement automation changes for systems.
• Review documentation to establish preventative maintenance procedures and calibrations.

Skills

Automation troubleshooting

Pharmaceutical automation

Allen Bradley PLCs

Reading P&ID drawings

Regulatory compliance

English communication

Education

BS degree in engineering

Tools

Studio 5000

FactoryTalk View

FactoryTalk Batch

Job description

We are looking for motivated and enthusiastic individuals to add to our growing central and eastern North Carolina team (up to 1.5 hours from Raleigh). MCA Services is a team of engineers dedicated to maximizing our client’s manufacturing potential. We offer a variety of manufacturing engineering services including compliance and automation needs in the food and pharmaceutical industries. Our engineers excel in our core reliability engineering, integration, and validation services - to identify, install, integrate, validate, and maintain the equipment that manufacturing companies need to thrive. Our team’s dedication and commitment help our clients achieve their business objectives and deliver critical products to patients nationwide.

What You Will Achieve

You will work side by side with the client’s team - playing a critical role in design and implementation of the manufacturing process to assist in delivering products to patients. Playing a critical role in design and implementation of the manufacturing process to assist in delivering products to patients. You will support various stages of production starting with startup / troubleshooting maintenance and automation support for equipment and utilities in operation on the manufacturing floor.

Role Summary

The candidate, with some direct supervision, will be responsible for providing maintenance and automation support during the qualification, implementation of changes and daily activities, including troubleshooting, of a variety of manufacturing equipment supporting filling and packaging of pharmaceutical products. The candidate will be required to maintain GMP documentation as required by the client. Including creating GMP electronic tickets to raise issues to be escalated to engineering support.

The candidate will work as part of a team providing rotating support during NIGHT SHIFT to support production equipment during routine production activities and implementation of program changes as related to equipment failure, automation changes / system enhancements and general troubleshooting needs.

Role Responsibilities

• Provides maintenance and automation troubleshooting support for new and existing systems during qualification and daily production activities
• Designs and implements automation changes for systems
• Review process and manufacturing equipment documentation to identify Critical Spare Parts
• Review equipment documentation and operation to establish preventative maintenance procedures and / or providing comments on existing procedures when necessary
• Review equipment instrumentation to identify required calibrated and noncalibrated instruments; including developing calibration procedures and / or providing comments on existing procedures when necessary
• Working knowledge of and ability to apply GMP, GAMP and CFR21 Part 11 guidelines to ensure compliance as they relate to qualification of the systems and processes
• Reviews vendor specifications / manuals and obtain an understanding of how the system works including identification of major components, instruments and functions to be able to provide maintenance and troubleshooting support

Required Skills

The candidate must possess the following knowledge, skills and abilities to perform the job requirements satisfactorily:

• Strong mechanical aptitude and troubleshooting skills are required.
• Strong technical knowledge, background and experience with automation of pharmaceutical processes, equipment, utilities, facility and/or computer systems as related to sterile products and medical devices in preferred.
• Experience within the pharmaceutical industry providing automation support with Allen Bradley PLCs with Studio 5000, FactoryTalk View and FactoryTalk Batch is required.
• Ability to read and interpret mechanical, electrical and P&ID drawings is required.
• Good organizational and analytical / problem-solving skills as well as a strong attention to detail; working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices is preferred.
• Strong command of English language and grammar.
• Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, SOPs and client expectations.
• Must be able to set and meet timelines or be able to recognize and schedule changes in response to project demands.
• Ability to work both in a team environment and independently with minimal supervision.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through verbal and written communication.
• Must be able to perform a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.
• Must have the ability to multi-task and handle multiple competing priorities and requirements to maintain strict deadlines.
• Must have the ability to interact with professionals and customers outside of the company to be able to interact with varying levels within the client’s company.
• Must be proactive, have experience with high performance teams, strong interpersonal and project management skills.
• Proficiency in Microsoft Office software suite (Word/Excel/PowerPoint).

Qualifications

• BS degree in engineering, manufacturing technology or related similar degree is required.
• Mechanical and/or automation knowledge is strongly preferred.
• 3 years+ of experience in Pharmaceutical Automation and / or Validation is preferred.
• If CAPM / PMP certification (required certification varies by entry role) is not already held by candidate there is a 1 year grace period to obtain necessary certification but candidate must be eligible to obtain at time of hire.

Work Schedule

• Schedule is NIGHTSHIFT from 6 PM – 6 AM onsite at the client’s location and MCA's office.
• Rotating schedule of 2 on and 3 off.
• A fulltime work week is 37.5 hours.
• PTO, Paid Holidays, 401k Match, Dental, Health and Vision Benefits. 90-day waiting period applies
• Salary range $108,400-$145,350 (base salary with additional annual bonus based on performance); compensation is based upon acquired skills and relevant experience.

Other Details

• Prior to first date of employment a background check and drug screening are required.
• MCA Services is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. MCA Services also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. MCA Services is an E-Verify employer.