Biotech Systems Specialist
2 days ago
AmplifyBio is a leading contract research organization that provides a comprehensive range of services, from discovery stage R&D work to manufacturing services for cell, gene, and mRNA-based therapeutics.
The OpportunityWe are seeking an experienced Biotech Systems Specialist to join our Quality IT team in New Albany, OH. As a key member of our team, you will be responsible for ensuring the health, data integrity, and regulatory compliance of GxP computerized systems.
Job Responsibilities- Maintain and support the health of GxP computerized systems to ensure data integrity and regulatory compliance.
- Develop and own technical SOPs and validation artifacts for new implementations or enhancements to existing systems.
- Lead and manage computerized system validation activities to ensure effective requirements are captured and controls are in place to meet global regulatory requirements.
- Perform and author data integrity and GxP risk assessments to identify areas for improvement.
- Collaborate with various stakeholders to assess and select computerized systems that meet high-level business needs.
- Drive resolution to technical issues, including audit and inspection related regulatory non-conformances.
We are looking for a highly motivated and experienced professional with:
- A minimum of 5 years' experience in GxP computer system validation, data integrity, and regulatory compliance in a pharmaceutical or biotech environment.
- In-depth knowledge of regulations (FDA/EU/ICH), with emphasis on 21 CFR Part 11, 210, 211, 58, and 820.
- Strong analytical and problem-solving skills, with the ability to work independently and collaboratively as part of a team.
- Excellent communication and interpersonal skills, with the ability to interact effectively with internal and external stakeholders.
As a Biotech Systems Specialist at AmplifyBio, you can expect a competitive salary package, including a base salary of $120,000 per year, plus benefits, and opportunities for professional growth and development.
We offer a dynamic and inclusive work environment, with a commitment to diversity, equity, and inclusion. If you are passionate about working in a fast-paced, cutting-edge industry and have a strong desire to make a difference, we encourage you to apply for this exciting opportunity.
-
Leading GxP System Specialist
3 weeks ago
New Albany, Ohio, United States AmplifyBio Full timeAmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO performing safety efficacy and toxicology studies for small molecules and advanced therapies alike, and, most recently, an expansion into manufacturing services for cell,...
-
Lead Computer Systems Validation Specialist
1 week ago
New Albany, Ohio, United States AmplifyBio Full timeAbout AmplifyBioAmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO performing safety efficacy and toxicology studies for small molecules and advanced therapies alike, and, most recently, an expansion into manufacturing...
-
Top-Quality Systems Analyst
3 weeks ago
New Albany, Ohio, United States AmplifyBio Full timeSenior Systems Analyst, QIT Job Description:AmplifyBio is seeking a highly skilled Senior Systems Analyst, QIT to join our team in New Albany, OH. As a critical member of the Quality IT (QIT) department, you will lead the implementation and maintenance of GxP computerized systems, ensuring compliance with all applicable regulations.Key...
-
Electrical Maintenance Systems Specialist
3 weeks ago
New Albany, Ohio, United States M.C. Dean, Inc. Full timeElectrical Maintenance Systems SpecialistAbout M.C. Dean, Inc.M.C. Dean, Inc., a leading provider of electrical engineering and construction services, seeks an experienced Electrical Maintenance Systems Specialist to join our team. The successful candidate will be responsible for maintaining and ensuring the reliable operation of all electrical systems...
-
Manufacturing Systems Specialist
2 days ago
New Albany, Ohio, United States American Cybersystems Full time**Job Overview**Innova Solutions, a leading provider of technical engineering services, is seeking an experienced Manufacturing Systems Specialist to join our team. As an Associate Mfg Systems Engineer, you will play a critical role in providing technical engineering support for system/equipment optimization strategies, upgrades, replacements, and...
-
Smartsheet System Administrator
2 days ago
New Albany, Ohio, United States Dale Workforce Solutions Full timeEstimated Salary: $90,000 per yearThe estimated salary for this position is based on industry standards and location. This figure may vary depending on individual qualifications and experience.
-
Onsite Power Systems Specialist
17 hours ago
New Albany, Ohio, United States Pkaza LLC Full timeAbout the RoleThis is an exciting opportunity to join our team as an Onsite Power Systems Specialist. As part of this role, you will be responsible for managing the design of critical power systems for new data centers and expansions to existing data centers. You will work closely with our design team to ensure that all projects are completed on time and...
-
Data Center Systems Specialist
7 days ago
New Albany, Ohio, United States Quality Technology Services, LLC Full timeQuality Technology Services, LLC (QTS) is a leading provider of world-class data center solutions. We are seeking a Data Center Systems Specialist to join our team. This is a unique opportunity to work on sophisticated system platforms and align with business objectives.ResponsibilitiesThe ideal candidate will be responsible for:Ensuring DCIM systems operate...
-
Onsite Power Systems Specialist
2 days ago
New Albany, Ohio, United States Pkaza LLC Full timeWe are seeking an experienced Onsite Power Systems Specialist to join our team at Pkaza LLC. In this role, you will be responsible for assisting with the interpretation of design requirements from clients and translating them into a design that fits the specific needs of the data center being built.The ideal candidate will have experience working with...
-
Business Systems Optimization Specialist
2 days ago
New Albany, Ohio, United States Ryder Full timeJob Summary">Ryder seeks a highly skilled Business Systems Optimization Specialist to join our team. This role will involve analyzing and optimizing business systems to improve efficiency and effectiveness.">Key Responsibilities">">Analyze and optimize business systems to improve efficiency and effectiveness.">Develop and implement process improvements to...
-
Onsite Power Systems Specialist
7 days ago
New Albany, Ohio, United States Pkaza LLC Full timeAbout the RoleWe are seeking an Onsite Power Systems Specialist to join our team in New Albany, OH. In this role, you will be responsible for managing the design of critical power systems for new data centers and expansions to existing facilities, working closely with clients to interpret design requirements, and communicating effectively with internal teams...
-
Electrical Commissioning Engineer
3 weeks ago
New Albany, Ohio, United States Pkaza Full timeJob OverviewWe are seeking a highly skilled Electrical Commissioning Engineer to join our team at Pkaza LLC. As a critical systems specialist, you will be responsible for ensuring the smooth operation of large facility projects.
-
Compounding Pharmacist Specialist
2 hours ago
New Middletown, Ohio, United States Conflux Systems Full timeJob Title: Compounding Pharmacist SpecialistLocation: Mendota Heights, MNEstimated Salary: $120,000 - $150,000 per yearAbout the JobWe are seeking a skilled Compounding Pharmacist Specialist to join our team at Conflux Systems. As a specialist in infusion compounding, you will play a critical role in supporting our business by providing cost-effective...
-
Engineering Validation Leader
18 hours ago
New Albany, Ohio, United States BioSpace, Inc. Full timeJob Title: Senior ManagerAbout the JobThis is a leadership role in which you will be responsible for leading and coordinating site validation processes for equipment and combination products at Amgen Ohio.Develop and implement validation plans and strategies.Evaluate proposed changes to validated systems and recommend validation levels.About YouYou should...
-
Dining Services Specialist
3 weeks ago
New Albany, Ohio, United States Mount Carmel Health System Full timeJob Summary:We are seeking a highly skilled Dining Services Specialist to join our team at Mount Carmel Health System. In this role, you will be responsible for preparing and serving high-quality meals to patients, staff, and visitors.About the Role:Prepare and cook large quantities of food according to recipes and dietary guidelines.Maintain a clean and...
-
Operations and Design Expert
7 days ago
New Albany, Ohio, United States Aditi Consulting Full timeAbout the Position:We are seeking a highly skilled Operations and Design Expert to join our team at Aditi Consulting. The successful candidate will be responsible for designing and implementing efficient operations and designs that meet client needs.Key Responsibilities:Design and implement efficient operations and designs.Collaborate with cross-functional...
-
Pharmacist - Compounding Specialist
14 hours ago
New Middletown, Ohio, United States Conflux Systems Full timeJob OverviewWe are seeking a highly skilled Pharmacist to join our team at Conflux Systems as an Infusion Compounding Specialist.This role involves supporting the development and implementation of cost-effective solutions for patients requiring specialized therapies.The ideal candidate will have experience in home healthcare infusion therapy compounding and...
-
Senior Manager
2 days ago
New Albany, Ohio, United States BioSpace, Inc. Full timeSite Validation Leadership RoleWe are seeking a Senior Manager to lead and coordinate site validation processes for equipment and combination products at Amgen Ohio.Team ManagementManage a team of engineers and contractors to perform validation activities.Key ResponsibilitiesEnsure initiation, preparation, and closeout of validation-related documents and...
-
Electrical Systems Design Specialist
2 days ago
New Albany, Ohio, United States ZipRecruiter Full timeTowerPinkster, a leading architecture, engineering, and interior design firm, is seeking an experienced Senior Electrical Engineer to join our team in Michigan, Indiana, or Kentucky. This role involves designing electrical systems for projects from inception to completion, collaborating with clients, and leading the design team through the development of...
-
Technical Engineer
7 days ago
New Albany, Ohio, United States Aditi Consulting Full timeAbout the Role:We are seeking a talented Technical Engineer to join our team at Aditi Consulting. This is an exciting opportunity for individuals with a strong background in engineering and problem-solving skills.Job Summary:The Technical Engineer will be responsible for providing solutions to technical problems, evaluating and selecting standard engineering...