Electronic Batch Records Specialist
Kalamazoo, MI 49001
- Working in the Oral Solid Dose (OSD) Value Stream with Kalamazoo site Werum PAS-X Electronic Batch Records (EBR) team, this position has the responsibility for creating/updating EBR for new and existing product deployment of the Werum PAS-X Electronic Batch Records (EBR) solutions.
- The Electronic Batch Record Specialist will be the primary point of contact for the deployment of new EBR, working with our internal business partners to understand business needs required for ITS solutions to support operational and business processes.
The Electronic Batch Record Specialist will:
- Learn existing EBR system structure to support current business practice.
- Learn entire site process for documents including Artwork, Quality, Planning and Operations.
- Serve OSD operations customers to develop or modify PAS-X documents which enable the manufacturing process.
- Provide expertise on document design to achieve clarity and efficiency in the manufacturing operation, while complying with all cGMP regulations.
- Provide insight and recommendations to improve EBR system structure based on manufacturing processes.
- The role will be primarily hands-on technical development and support work.
ITS Problem Resolution:
- Provide support to our business in response to OSD personnel requests.
- Resolve problems and identify issue-prevention opportunities and solutions, demonstrating true service excellence
Ongoing Business Support:
- Interface with our internal business partners in the understanding of business requirements.
- Actively engage with the business to identify and develop continuous improvement initiatives/activities.
- Engage with site EBR team in the identification, evaluation and recommendation of information solutions.
- Assist with definition of solution scope and development of project plans
- Engage with ITS and EBR support teams in the identification of required improvements.
- Engage with the business while working with site resources to identify and define process improvements utilizing existing application footprint
- Perform testing to demonstrate viability of solutions. Requires experience with GMP (Good Manufacturing Practices) procedures.
- Participate in the effort to educate our internal business partners on the end-to-end nature of solutions
- Development of EBR document design to achieve clarity and efficiency in the manufacturing operation, while complying with all cGMP regulations.
- Assist in the development of clearly written specification documents, work instructions, qualification, and/or support and training materials. Requires experience with GMP documentation
- Prepare routine reports or status updates for business partners on the status of systems or program roll-outs
- Bachelor’s degree in Information Technology, Computer Science, or a related technical degree
- 2+ years of experience in the following areas:
- Business process analysis and design; ability to translate business needs into technical requirements
- Clear understanding of software development lifecycle and Application support; Project Management; Working knowledge of networking and systems design
- Use of information system development methodologies as applied in a GMP regulated environment
- Technology experience: Shop floor solutions, ERP, and/or equivalent pharmaceutical manufacturing systems; data management and Business Intelligence solutions
- ITS support of manufacturing and quality operations.
- Experience with shop floor systems and/or other manufacturing floor solutions
- Some experience with SAP PP/PI and QM highly desirable
- Excellent communication skills (both written and oral), and an ability to interact effectively with all levels of the organization is required.
- Must be self-motivated and willing to learn new and changing responsibilities. Works both independently and in a team environment.
- Understanding of GMP requirements as related to manufacturing operations and information systems
- Customer focus
- Strategic thinking and analytical skills
- Negotiation skills
- Fluency in English (written and spoken) is required
- Experience with System Development Life Cycle methodologies
- Software development skills with the .net platform, Sqlserver and/or Oracle
- Managing systems development lifecycle
- Understanding ERP solutions and architecture
- Business process analysis & design
- Understanding shop floor solutions
- Working knowledge of Werum’s PAS-X MES solution highly desirable
- Knowledge of SAP PP/PI and QM highly desirable
- Informatica development skills highly desirable
HKA Enterprises is a global workforce solutions firm. If you're seeking a new career opportunity or project experience, our recruiters will work to understand your qualifications, experience, and personal goals. At HKA, we recognize the importance of matching employee goals with those of the employer. We strive to seek credibility, satisfaction, and endorsement from all of our applicants. We invite you to take time and search for your next career experience with us! HKA is an EEO Employer who participates in the US Citizenship and Immigration Services E-Verify Program.
Director of Recruiting
Anne Cleveland is the Director of Recruiting at HKA Enterprises. She specializes in recruiting for the pharmaceutical and power industries. Anne's advice to job seekers is "avoid having your resume fall into a black hole after applying by following up your online application with a quick phone call, text, or email directly to the recruiter listed on the job posting." The best way to reach Anne is via text or email.