If you are looking to be part of an industry that changes peoples lives, then join our team. We are looking for service minded individuals to be a part of a diverse team working in a fast-paced pharmaceutical environment. Join us and find out what it means to work for a mission driven, value based company that believes in building strong relationships with our clients and team. Having leaders that take an interest in your growth and potential will genuinely make you feel like a part of the team.
At GPCi we value our team first. Our teammates are the key ingredient that makes us unique. They embody core values that strengthen our culture and guide our overall success. Our specialists must be knowledgeable and willing to go the extra mile in the service of the client, your success is our success. We are looking for career minded, team players who want to grow along with us and create an excellent client and teammate experience!
At GPCi, we see every day as a chance to create a positive impact. We lead through our values centered on service, integrity, community and family. From our support of Local Charities, to our Ministry Action Team, our values keep us dedicated to using our resources for good: good for our team, clients, industry and human kind.
SUMMARY OF POSITION
The Automated Systems Validation Specialist position involves technical writing, project planning, client interaction and project management. The position requires a working knowledge of FDA pharmaceutical manufacturing regulations and current Good Manufacturing Procedures (cGMP) as well as excellent technical writing skills, proficiency in word processing and spreadsheet programs.
An Automated Systems Validation Specialist is assigned a project and is expected to work with the client to establish a validation approach, generate the required life cycle documents, including URS, FRS and SDS documentation, to meet cGMP requirements, to be in compliance with FDA guidelines and client operating procedures. The documents often include installation and operational qualification protocols. These protocols may require the Automated Systems Validation Specialist to generate test plans and scripts and then assist with test execution and data collection. The Automated Systems Validation Specialist will then generate validation summary reports for the protocols and change control documents. This position often requires the development of requirement and design specifications for various pieces of pharmaceutical manufacturing equipment. Knowledge of industrial controllers and operator interfaces is required to generate these specifications.
The Automated Systems Validation Specialist is responsible for providing technical support to the manufacturing and logistics buildings at the client site for protocol and testing script development associated with software review, testing, trouble-shooting, and assessing/testing modifications and improvements to automated systems and data management/storage systems.
What you'll do:
- Tests automated systems, recipes, control systems, and Human Machine Interface (HMIs).
- Perform testing in a simulated environment (development/pre-production) or production environment.
- Basic understanding of converting sequences of operations into detailed design specifications (DDS).
- Advanced understanding of Good Automated Manufacturing Practice (GAMP) and GAMP categories.
- Understanding of validation principles, including familiarity with automated system principles such as I/O functionality, alarm activation and response, process sequential control, audit trail and data integrity, etc.
- Familiarity with one or more of the following:
- PLC systems, particularly Siemens and Rockwell Automation
- Distributed control systems, particularly Emerson DeltaV
- Building management systems, particularly Siemens and or Metasys
- IT infrastructure
- Proficiency in investigation, problem solving, risk assessment and mitigation.
- Subject matter expert for validation planning.
- Leads validation assessments for proposed changes.
- Advanced understanding of validation/documentation hierarchy.
What you’ll bring:
- B.S. in Engineering, Computer Science, or other technical field
- Proficient In Microsoft Word and Excel
- Excellent technical writing skills
- Minimum of 6 months experience in Automated Systems
- Minimum of 6 months of Pharmaceutical/Bioscience experience
What you’ll get:
We believe in a team mentality, and that happy teammates are successful ones. That’s why we give our team the tools and the autonomy to learn, grow, have fun and be themselves.
We invest in our team, with internal programs, training, and initiatives to develop your skills and help you reach your goals. We promote from within. We provide you with the tools, skills, and resources to develop, both professionally and personally. You choose where you want to go; we help you get there.
We strive to make the world a better place and empower others to do the same. We are missiondriven and we leverage the power of our team to make a positive impact in the communities in which we live and work.
We celebrate successes and reward our teammates for the hard work they do every day. We offer benefits to keep you healthy and happy, such as:
- Paid Time Off (PTO)
- Vacation
- Health Care
- Retirement IRA plan
- Short term disability
We are looking for a grammar guru who is seeking an opportunity to work in an industry that improves people's lives. You will need to be a skilled technical writer and editor. You will collaborate with a fun and close knit team to research and investigate procedures in order to suggest best practices to our clients. The right person for this role is passionate about the client experience and has attention to detail.
Join us and find out what it means to work for a mission driven, values-based company that believes in building strong relationships with our clients and team. Having leaders that take an interest in your growth and potential, you will genuinely feel like part of a family.
What you will do
- Draft, route and get final approval for updated documents
- Establish/Write procedures using MS Word and Excel
- Enter data into change control computer systems
- Schedule and lead meetings
- Communicate project status to management and client project managers
- Complete time sheets for project tracking
What you will bring with you
- 2 or more years of experience in pharmaceutical manufacturing environment
- In-depth understanding of good documentation practices (GDP) and cGMP
- Experience with writing and editing standard operating procedures (SOPs)
- Experience and knowledge with Batch Records in routing, editing, reviewing, assessing, approving and implementing
- Knowledge of instrumentation processes, ranges and uses with an ability to document this information for system entry
- Experience with maintenance systems for spare parts or maintenance procedures a plus
- Skilled in technical writing and document control
- Must have a project management mentality and excellent communication skills
- Must have proven organizational skills to maintain data and documentation
- Ability to work independently without direction but also able to work within a team
- Ability to research and investigate to confirm procedures and suggest best practices
- Proficient with MS Word and Excel
- Must have valid driver’s license and reliable transportation
- This is not a remote position
What you will get
We believe in a team mentality, and that happy teammates are successful ones. That’s why we give our team the tools and the autonomy to learn, grow, have fun and be themselves.
We invest in our team, with internal programs, training, and initiatives to develop your skills and help you reach your goals. We promote from within. We provide you with the tools, skills, and resources to develop, both professionally and personally. You choose where you want to go; we help you get there.
We strive to make the world a better place and empower others to do the same. We are mission-driven and we leverage the power of our team to make a positive impact in the communities in which we live and work.
We celebrate successes and reward our teammates for the hard work they do every day. We offer benefits to keep you healthy and happy, such as:
- Paid Time Off (PTO)
- Vacation
- Health Care
- Retirement IRA plan
- Short term disability
At GPCi we value our team first. Our teammates are the key ingredient that makes us unique. They embody core values that strengthen our culture and guide our overall success. Our specialists must be knowledgeable and willing to go the extra mile in the service of the client, your success is our success.
We are looking for career minded, team players who want to grow along with us and create an excellent client and teammate experience!
At GPCi, we see every day as a chance to create a positive impact. We lead through our values centered on service, integrity, community and family. From our support of Local Charities, to our Ministry Action Team, our values keep us dedicated to using our resources for good: good for our team, clients, industry and human kind.
What you will do (including but not limited to)
- Draft, execute and close out qualification and validation (IQ, OQ, PQ) projects for plant utilities, facilities, equipment, or computer systems projects
- Establish/write validation plans using MS Word
- Execute validation strategies and acceptance criteria based on established site, industry and regulatory standards
- Development or revision of requirement and design specifications
- Establishing traceability from specifications to test scripts
- Processing change control requests documents
- Investigating unexpected events and classifying incidents and documenting their impact
- Performing risk assessments for requested changes to validated systems
- Summarize validation results in well organized, accurate and complete manor
- Gather information needed to design the protocols by interacting with clients
- Route validation documents for initial and final approval, this will require the ability to walk and carry binders of documents at times (client dependent)
- Plan, schedule, execute protocols and test scripts and communicate project status.
- Develops a working knowledge of the project budget, and works to stay within allotted budget for all project aspects
- Communicate project status to management and client project managers
- Schedule and lead project meeting using excellent communication skills
- Review client Standard Operating Procedures (SOP), cGMP and FDA regulations
- Complete time sheets for time tracking
What you will bring with you
- 3 or more years or more experience in pharmaceutical manufacturing environment
- In-depth understanding of all system lifecycle deliverables from Commissioning & Qualification (C&Q) and Computer System Validation (CSV) documents
- Experience with Automated Systems (PLC, HMI)
- Experience with pharmaceutical manufacturing systems and equipment such as: Sterilizers, Isolator technology, Fillers, HVAC systems, and Utility systems
- Must be proficient in the ability to write validation protocols and reports
- Skilled in technical writing and document control
- Must have a project management mentality and excellent communication skills
- Must have strong organizational skills to maintain data and documentation
- Ability to work independently without direction but also able to work within a team
- Proficient with MS Word and Excel
- Must have valid driver’s license and reliable transportation
- Must be willing to commute within central to eastern NC – this is not a remote position
What you will get
We believe in a team mentality, and that happy teammates are successful ones. That’s why we give our team the tools and the autonomy to learn, grow, have fun and be themselves.
We invest in our team, with internal programs, training, and initiatives to develop your skills and help you reach your goals. We promote from within. We provide you with the tools, skills, and resources to develop, both professionally and personally. You choose where you want to go; we help you get there.
We strive to make the world a better place and empower others to do the same. We are missiondriven and we leverage the power of our team to make a positive impact in the communities in which we live and work.
We celebrate successes and reward our teammates for the hard work they do every day. We offer benefits to keep you healthy and happy, such as:
- Paid Time Off (PTO)
- Vacation
- Health Care
- Retirement IRA plan
- Short term disability