Validation Specialist

Why We Need You

We are looking for motivated and enthusiastic individuals to add to our growing eastern to central North Carolina team (up to 1 hour 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. You will leverage your technical capabilities to support multiple projects across several disciplines providing assistance with requirement specification, qualification and documentation of equipment and systems as well as providing startup and troubleshooting support. You will support various stages of production starting with specification requirements for new equipment qualification to troubleshooting production process problems with equipment already in operation.

Role Summary

The candidate, with some direct supervision, will be responsible for the qualification and implementation of a variety of manufacturing equipment supporting filling and packaging of liquid pharmaceutical products. Frequent collaboration with the client’s Manufacturing, Engineering, Validation and Quality departments will be critical to ensure successful outcomes for the documentation development and execution for commissioning and qualification activities for the client’s utilities, facilities, processes, and equipment. The candidate will be required to maintain GMP documentation as required by the client.

The candidate will work as part of a team to support installation of new equipment beginning with initial design specifications through implementation including protocol generation, execution, change control ownership and supporting documentation creation. In addition to installing new equipment, the candidate will often work to support process improvements for the client’s existing equipment as related to equipment failure, automation changes or system enhancements. Responsibilities may include generating documents such as specification documents, protocols for commissioning or qualification of equipment, facilities and utilities and execution support. The candidate will have the opportunity to support the client in both large- and small-scale projects to specify, install / integrate, validate and troubleshoot systems including equipment, facilities, utilities and computer systems. Additionally, change control ownership will be required to keep finished projects, equipment, processes and facilities in compliance with contemporary industry standards and regulatory filings.

Role Responsibilities

• Collaborates with client’s stakeholders to define the system needs and requirements to generate specification documents (User Requirements Specification, Design Specification, Functional Specification, etc.) to support subsequent testing and implementation
• 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
• Authors Life Cycle documentation including Risk Assessments, Project Validation Plans, equipment classification assessments, and alarm assessments to identify required testing based on system criticality
• Reviews vendor specifications / manuals and obtain an understanding of how the system works including identification of major components, instruments and functions to translate system requirement specifications into executable test cases developed to accurately confirm the system meet the requirements for intended use
• Generates protocols for commissioning to identify process capabilities of the system, engineering studies to establish critical parameters and qualification to confirm established parameters
• Executes protocols and prepares final reports / packages for approval
• Assists with deviation / failure investigations and reports
• Initiates and owns Change Controls within the client’s system
• Provides project planning, management, execution, and follow up during regular meetings to the client
• Generates production support documentation such as Batch Records and Standard Operating Procedures to accompany equipment installations / modifications

Required Skills

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

• Experience within the pharmaceutical industry providing automation support with Allen Bradley PLCs with Studio 5000, FactoryTalk View and FactoryTalk Batch is preferred.
• 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.
• Strong technical knowledge, background and experience with validation / qualification of pharmaceutical processes, equipment, utilities, facility and/or computer systems as related to sterile products and medical devices in preferred.
• Strong mechanical aptitude and troubleshooting skills are preferred.
• Ability to read and interpret P&IDs is a plus.
• 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.
• 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. Strong conflict resolution skills.
• 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. Frequently interacts with others to obtain or relate information to diverse groups.
• 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 be able to set and meet timelines or be able to recognize and schedule changes in response to project demands and relay impact to project management.
• 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 professions 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.
• Strong command of English language and grammar.
• Proficiency in Microsoft Office software suite (Word/Excel/PowerPoint).

Qualifications

• BS/BA degree in science, engineering, manufacturing technology or related similar degree is required.
• 1 – 2 years of experience in Pharmaceutical Validation and / or Process Engineering is preferred.
• Experience in pharmaceutical industry is strongly preferred.
• Mechanical and/or automation knowledge is a plus.

Work Schedule

• Schedule is primarily day shift Monday - Friday onsite at the client’s location and MCA's office.
• But at times it will be necessary to work according to the manufacturing shift schedules to support installation, execution or troubleshooting with on call night / weekend shift support.
• A fulltime work week is 37.5 hours.

Benefits

• PTO, Paid Holidays, 401k Match, Dental, Health and Vision Benefits. **90-day waiting period applies**
• Salary range $61,700 - $77,100 (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.