Process Specialist

INCOG BioPharma Services; Fishers (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

INCOG BioPharma Services seeks a Process Specialist to work with operations and quality systems, providing feedback for deviation investigations and CAPA implementation. The role requires aseptic manufacturing knowledge and cross-functional project leadership to improve process efficiency while upholding quality.

You will help author and review SOPs, lead root-cause analyses, and maintain data integrity in batch records.

Qualifications

• Knowledge of process control, quality engineering and statistics.
• Familiarity with quality/regulatory requirements and cGMPs.
• Strong communication across levels and teams.
• 4+ years in a GMP environment.
• Batch record and manufacturing report review experience.
• Deviation and technical writing experience.
• Client and regulatory audit experience.
• Excellent written and verbal communication skills.
• Experience with SCADA, LIMS and data analysis tools.

Responsibilities

• Support SOPs, work instructions, and efficiency improvements.
• Lead studies to optimize operation sequences and workflows.
• Review productivity and partner with operations on actions.
• Act as SME for aseptic processes and related quality controls.
• Lead root cause analysis using 5 Whys, fishbone diagrams, statistics.
• Collaborate across departments and with external clients.
• Manage multiple projects with deadlines in a fast-paced environment.
• Support FMEAs to assess process and product risks.
• Ensure data integrity in batch records using systems like SCADA/LIMS.

Tools

SCADA

LIMS

JMP

Minitab

Visio

Excel

Word

Job description

The Process Specialist is responsible for working directly with the operations team and is to work closely with the quality systems team to provide information and/or feedback for manufacturing deviation investigations and CAPA implementation. Additionally, the Process Specialist will possess aseptic manufacturing knowledge to serve as subject matter expert and demonstrate ability to influence positive outcomes without direct reporting authority. The Process Specialist is expected to champion cross-functional process improvement projects that address process gaps and process efficiency while maintaining quality results.

Essential Job Functions

• Support authoring, reviewing, and approving various SOPs & Work Instructions and if needed create news to improve efficiency.
• Directs or conducts studies to ascertain the best sequence of operations or workflow.
• Experience with time studies, work measurement, engineering standards and data collections.
• Review employees and department productivity and partner with operations to develop action plans to improve performance.
• Maintain effective communication with other departments and employees.
• SME for processes related to preparation, formulation, and filling
• Strong change management skills to challenge the status quo and drive improvements.
• Strong analytical, prioritizing, interpersonal, problem-solving, presentation, budgeting, project management (from conception to completion), & planning skills
• Lead root cause analysis activities for complex operational challenges, utilizing tools such as fishbone diagrams, 5 Whys, and statistical analysis
• Ability to develop and maintain collaborative relationships with peers and colleagues across the organization, as well as internal and external clients.
• Ability to work well autonomously managing multiple projects and within a team in a fast-paced and deadline-oriented environment.
• Ability to work with and influence peers and senior management.
• Self-motivated with critical attention to detail, deadlines and reporting
• Participate and support equipment/process FMEAs to understand process and product risks.
• Participate and report to a cross-functional team to advance project activities.
• Work flexible hours for the coverage of project demand.
• Other duties as assigned
• Utilize various paper and automated systems (eDMS, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity in batch records.
• Exemplify and take proactive approaches in terms of safety expectations, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals.

Job Requirements

• Knowledge of process control, quality engineering, sampling requirements, statistical techniques, and process capability.
• Familiarity with relevant quality and regulatory requirements and trends and cGMP's.
• Strong communication skills and the ability to build relationships with colleagues across all levels of the organization, including business managers, operations leaders, and technical leaders.
• 4 years minimum experience working in a GMP environment.
• Batch record and associated manufacturing report review experience.
• Deviation and technical writing experience.
• Client and Regulatory Agency audit experience.
• Excellent written and verbal communication skills.
• General computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.).

Additional Preferences

• 1-2 years demonstrated working knowledge of aseptic manufacturing operations.
• 1-2 years in a people leadership role.

Additional info about INCOG BioPharma Services

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

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