Process Specialist

incog; Fishers (IN); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Smoke-free campus

Job summary

INCOG BioPharma Services is seeking a Process Specialist to collaborate with the operations and quality systems teams in Fishers, IN. The role focuses on investigating manufacturing deviations, implementing CAPAs, and ensuring data-driven improvements in aseptic processes.

Ideal candidates will have extensive GMP experience, strong analytical and communication skills, and the ability to influence outcomes without direct authority.

Qualifications

• Minimum 4 years in a GMP environment.
• Proven experience in deviation investigations and CAPA implementation.
• Knowledge of process control and quality engineering principles.
• Familiarity with regulatory requirements and cGMP trends.
• Strong written and verbal communication skills.

Responsibilities

• Support authoring, reviewing, and approving SOPs and Work Instructions; create new ones to improve efficiency.
• Lead or participate in studies to optimize workflow and operations.
• Review batch records and manufacturing reports for accuracy.
• Drive cross-functional action plans to improve performance with operations.
• Act as SME for aseptic processing and related fill/finish steps.
• Perform root cause analyses using tools like fishbone diagrams and 5 Whys.

Skills

GMP knowledge

Change management

Root cause analysis

Cross-functional collaboration

Communication skills

Data analysis

Project management

Documentation writing

Time management

Education

Bachelor's degree in a life sciences-related field

Tools

SCADA

LIMS

Minitab

JMP

Excel

Job description

Process Specialist

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.

The Process Specialist will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences.Authoring comprehensiveinvestigationsthatleverage facts and data to support robust root cause conclusions,effectivecorrective actions, andsystematicall-encompassingpreventative actions.They will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills.

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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