IT Systems Engineer – TechOps & Pharma Lab Systems
Spectraforce
Frederick, Maryland
a month ago
Job Description
Job Title: IT Systems Engineer – TechOps & Pharma Lab Systems
Location: Frederick, MD
Duration: 6+ Months
Experience and Education:
• Master’s degree in Computer Science or Information Systems and 8+ years of industry experience OR
• Bachelor’s degree in Computer Science or Information Systems and 10+ years of industry experience OR
• Associate’s degree in Computer Science or Information Systems and 12+ years of industry experience
Responsibilities of the IT Engineering Specialist include, but are not limited to:
• Responsible for the delivery of global, site-specific, and compliant IT solutions within the TechOps IT portfolio and provide operational support.
• Ensure delivery of IT solutions to QC labs, R&D labs, and manufacturing.
• Perform installation, configuration, support, and administration of computer systems and lab instruments in a regulated GMP environment.
• Provide maintenance and support requests to address IT operational issues on assigned technologies, following established processes and procedures.
• Collaborate with business groups, vendors, and cross-functional teams to deliver innovative, scalable, and compliant IT solutions.
• Document user and functional requirements.
• Support IT architecture by working closely with enterprise architects and following established guidelines. Present solutions’ architecture the architecture review board.
• Design and implement site specific, regional, global, enterprise, and other IT solutions. Author detailed design specifications, architecture and data flow diagrams.
• Author and execute test scripts. Work with vendors and quality teams on authoring and execution of IQ/OQ/PQ to qualify IT solutions.
• Follow SDLC, PMM, Agile and other methodologies for projects and systems delivery.
• Work closely with project managers and the PMO on scheduling and monitoring progress of initiatives. Provide project tasks estimates Contribute to the discussions about resource allocation and capacity planning.
• Address project constraints, including risks and issues. Follow project change control for managing scope and schedule.
• Collaborate with internal & external stakeholders to diagnose and resolve IT issues.
• Ensure the availability and functionality of both hardware and software systems for daily operations, providing technical support on-site or remotely when necessary.
• Manage changes in accordance with GxP and IT change control processes, ensuring SLAs and KPIs are consistently met.
• Stay aligned with domain architecture teams to ensure global consistency, influencing changes to standards when needed.
• Document process steps and systems enhancements required to support process
• Engage with internal clients and stakeholders to address issues with quality and manufacturing systems.
• Analyze security protection technologies, adhering to Corporate IT security policies and guidelines.
• Develop a deep understanding of the business processes and all applicable procedures
• Foster strong relationships with clients and stakeholders.
• Ensure alignment between manufacturing sites and corporate IT for global consistency.
Qualifications:
• Experience with quality labs and manufacturing instruments, IT solutions, operating systems, security concepts, infrastructure, and systems’ configurations and customization.
• Previous experience working in a GxP environment supporting biotech/pharma technology solutions.
• Strong knowledge of commissioning, qualification, and validation processes.
• Experience with system integration and the ability to engage with stakeholders at all levels in an international environment.
• Demonstrated ability to work under indirect supervision and managing multiple competing priorities concurrently.
• Strong planning and execution skills, with a systematic approach to problem solving.
• 5-7 years of experience related to IT systems management, IT operational support or other information technology solutions roles, ideally in an international setting.
• Excellent oral and written communication skills.
• Strong analytical and problem-solving skills.
• High attention to detail in both technical and administrative tasks.
• Broad knowledge of IT topics, with proficiency in working in a secure network environment.
• Resilience and adaptability to perform effectively in an ambiguous and high-pressure environment.
• Honest and credible, and effective in communication.
About Us: SPECTRAFORCE is one of the fastest-growing workforce solutions firms in the United States. As a diversity-owned business, we place human connection at the heart of everything we do, building strong relationships with both clients and candidates to fill roles successfully. Our teams in North and Central America and India serve more than 150 Fortune clients globally, leveraging custom AI technology to provide direct hire, executive search, nearshoring, offshoring, and project staffing solutions.
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $60.00/hr.
Location: Frederick, MD
Duration: 6+ Months
Experience and Education:
• Master’s degree in Computer Science or Information Systems and 8+ years of industry experience OR
• Bachelor’s degree in Computer Science or Information Systems and 10+ years of industry experience OR
• Associate’s degree in Computer Science or Information Systems and 12+ years of industry experience
Responsibilities of the IT Engineering Specialist include, but are not limited to:
• Responsible for the delivery of global, site-specific, and compliant IT solutions within the TechOps IT portfolio and provide operational support.
• Ensure delivery of IT solutions to QC labs, R&D labs, and manufacturing.
• Perform installation, configuration, support, and administration of computer systems and lab instruments in a regulated GMP environment.
• Provide maintenance and support requests to address IT operational issues on assigned technologies, following established processes and procedures.
• Collaborate with business groups, vendors, and cross-functional teams to deliver innovative, scalable, and compliant IT solutions.
• Document user and functional requirements.
• Support IT architecture by working closely with enterprise architects and following established guidelines. Present solutions’ architecture the architecture review board.
• Design and implement site specific, regional, global, enterprise, and other IT solutions. Author detailed design specifications, architecture and data flow diagrams.
• Author and execute test scripts. Work with vendors and quality teams on authoring and execution of IQ/OQ/PQ to qualify IT solutions.
• Follow SDLC, PMM, Agile and other methodologies for projects and systems delivery.
• Work closely with project managers and the PMO on scheduling and monitoring progress of initiatives. Provide project tasks estimates Contribute to the discussions about resource allocation and capacity planning.
• Address project constraints, including risks and issues. Follow project change control for managing scope and schedule.
• Collaborate with internal & external stakeholders to diagnose and resolve IT issues.
• Ensure the availability and functionality of both hardware and software systems for daily operations, providing technical support on-site or remotely when necessary.
• Manage changes in accordance with GxP and IT change control processes, ensuring SLAs and KPIs are consistently met.
• Stay aligned with domain architecture teams to ensure global consistency, influencing changes to standards when needed.
• Document process steps and systems enhancements required to support process
• Engage with internal clients and stakeholders to address issues with quality and manufacturing systems.
• Analyze security protection technologies, adhering to Corporate IT security policies and guidelines.
• Develop a deep understanding of the business processes and all applicable procedures
• Foster strong relationships with clients and stakeholders.
• Ensure alignment between manufacturing sites and corporate IT for global consistency.
Qualifications:
• Experience with quality labs and manufacturing instruments, IT solutions, operating systems, security concepts, infrastructure, and systems’ configurations and customization.
• Previous experience working in a GxP environment supporting biotech/pharma technology solutions.
• Strong knowledge of commissioning, qualification, and validation processes.
• Experience with system integration and the ability to engage with stakeholders at all levels in an international environment.
• Demonstrated ability to work under indirect supervision and managing multiple competing priorities concurrently.
• Strong planning and execution skills, with a systematic approach to problem solving.
• 5-7 years of experience related to IT systems management, IT operational support or other information technology solutions roles, ideally in an international setting.
• Excellent oral and written communication skills.
• Strong analytical and problem-solving skills.
• High attention to detail in both technical and administrative tasks.
• Broad knowledge of IT topics, with proficiency in working in a secure network environment.
• Resilience and adaptability to perform effectively in an ambiguous and high-pressure environment.
• Honest and credible, and effective in communication.
About Us: SPECTRAFORCE is one of the fastest-growing workforce solutions firms in the United States. As a diversity-owned business, we place human connection at the heart of everything we do, building strong relationships with both clients and candidates to fill roles successfully. Our teams in North and Central America and India serve more than 150 Fortune clients globally, leveraging custom AI technology to provide direct hire, executive search, nearshoring, offshoring, and project staffing solutions.
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $60.00/hr.