Qureos Mentor

INCOG BioPharma Services

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 Do you have a passion for ensuring sterile injectable manufacturing processes are robust, reproducible, and compliant? INCOG BioPharma's Quality Assurance team is expanding, and we're looking for a process validation professional with hands-on experience and a strong command of the three-stage process validation life cycle.
 
 
 The Senior Quality Process Validation Specialist provides QA oversight of Process Design (Stage 1), Process Performance Qualification (Stage 2), and Continued Process Verification (Stage 3) activities across the site. This role is responsible for ensuring validation protocols, risk assessments, PPQ studies, and CPV programs meet applicable regulatory expectations and internal procedures, while taking direct, hands-on ownership of protocol design, execution, lifecycle documentation, and ongoing process monitoring.
 
 
 
 Essential Job Functions:
 
 
 
 <ul>
 <li>
 Provide QA oversight and approval of process validation activities of aseptically filled drug product across all three stages of the process validation life cycle, including Process Design, Process Performance Qualification (PPQ), and Continued Process Verification (CPV).
 </li>
 <li>
 Review and approve process validation life cycle documents including risk assessments, process flow diagrams, critical process parameter (CPP) and critical quality attribute (CQA) identification, validation protocols, and summary reports.
 </li>
 <li>
 Ensure all process validation activities are performed in compliance with FDA, EMA, and applicable regulatory requirements, ICH guidelines (including ICH Q8, Q9, Q10, Q11, Q12), and internal SOPs.
 </li>
 <li>
 Oversee process-related change controls to ensure appropriate revalidation assessments are performed, documented, and closed in a timely manner.
 </li>
 <li>
 Participate in the development, review, and revision of process validation-related SOPs, policies, and guidance documents.
 </li>
 <li>
 Serve as a QA subject matter expert during internal and external audits and regulatory inspections related to process validation activities.
 </li>
 <li>
 Support deviation investigations and CAPA activities related to process validation, PPQ, and continued process verification; review and approve deviations associated with process validation
 </li>
 <li>
 Maintain current knowledge of regulatory trends, guidance documents, and industry best practices related to process validation, including FDA&rsquo;s 2011 Process Validation Guidance, EU Annex 15, and ICH Q8-Q12.
 
 
 
 </li>
 </ul>
 
 Special Job Requirements:
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in a science or engineering field (e.g., Chemistry, Biology, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or related discipline).
 </li>
 <li>
 Minimum of 5 years of experience in pharmaceutical, biopharmaceutical, or CDMO manufacturing with direct involvement in process validation activities.
 </li>
 <li>
 Demonstrated hands-on experience in designing and executing process validation protocols, including Process Performance Qualification (PPQ) studies, for aseptically filled drug product.
 </li>
 <li>
 Working knowledge of the three-stage process validation life cycle as defined in the FDA 2011 Process Validation Guidance, including Process Design, Process Performance Qualification, and Continued Process Verification.
 </li>
 <li>
 Direct experience with critical process parameter (CPP) and critical quality attribute (CQA) identification, statistical process monitoring, and process capability analysis. Familiarity with NOR/PAR determination, and other process design and qualification using ICH Q8 methodology.
 </li>
 <li>
 Thorough understanding of FDA, EMA, and ICH regulatory requirements and guidance documents applicable to process validation (e.g., FDA Process Validation Guidance, EU Annex 15, ICH guidances; PDA and ISPE Process Validation and Technology Transfer guidances).
 </li>
 <li>
 Familiarity with technology transfer activities and the associated process validation requirements for new product introductions.
 
 
 
 </li>
 </ul>
 
 Additional Preferences:
 
 
 
 <ul>
 <li>
 Experience in a sterile injectable or aseptic manufacturing environment, particularly within a CDMO setting.
 </li>
 <li>
 Experience with aseptic processing validation, including media fills, hold time studies, shipping validation, and container closure integrity testing.
 </li>
 <li>
 Prior experience supporting regulatory inspections (FDA, EMA, Health Canada) or client audits related to process validation activities.
 </li>
 <li>
 Working knowledge of statistical tools and software used for process capability analysis, control charting, and continued process verification trending (e.g., Minitab, JMP).
 </li>
 <li>
 Experience authoring or reviewing Annual Product Quality Reviews (APQRs) or Product Quality Reviews (PQRs) as part of continued process verification programs.
 
 
 
 </li>
 </ul>
 
 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.
 
 
 
 
 By submitting your resume and details, you are declaring that the information is correct and accurate.
 
</div>

Senior Quality Process Validation Specialist

<div>Operations Manager Summary (2nd shift)

The Operations Manager is responsible for the implementation and establishment of effective management of labor, productivity, quality control, and safety measures. The Operations Manager will; ensure safe and efficient operations. Serve as a company representative during audits, client tours and regulatory agencies. Enhance the operational procedure, systems, and principles in the manufacturing areas look for opportunities to expand and enhance our processes and systems. Carry out supervisory responsibilities and ensure that all work completed is within appropriate timeframes, delivering daily expectations and assignments as well as provide on floor support and review of MBR&rsquo;s, and coaching and feedback to the operations team.

Operations manager duties and responsibilities may include interviewing, selection, and hiring; training new and existing employees; planning, assigning, and directing work; authoring and discussing with employees performance appraisals; addressing employee performance and corrective action plans; employee motivation and rewards. Organizing the budget of the company in collaboration with the Vice President of Operations.

This individual will ensure that all work is carried out in accordance with regulatory requirements, Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs) The Operations Manager will constantly evaluate the internal processes and procedures and work to create a productive space while maintaining the highest possible quality standards. 
Key responsibilities:
<ul><li>
Provide technical support, oversite and team leadership in manufacturing batch activities.</li><li>
Interviewing, selection, and hiring; training new and existing employees.</li><li>
Develop and improve current processes to maintain and control the formulation and filling operations.</li><li>
Planning, assigning, and directing work</li><li>
Communicate job expectations; planning, monitoring, appraising, and reviewing job contributions</li><li>
Develop, implement, enforce and evaluate operational processes, procedures and policies</li></ul> 

Special Job Requirements:
<ul><li>
Strong knowledge of process control, quality engineering, sampling requirements, statistical techniques, and process capability</li><li>
Knowledge of relevant quality and regulatory requirements and trends and cGMP's</li><li>
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.</li><li>
Strong knowledge of Aseptic techniques and processing</li><li>
8 years demonstrated working knowledge of pharmaceutical manufacturing operations.</li><li>
5 years in a people leadership role</li></ul> 
Additional info about INCOG BioPharma Services:

At INCOG BioPharma we are building 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. 
We are in the process of constructing the GMP facility and organization from the ground-up, which gives us the opportunity to leverage the knowledge we&rsquo;ve gained over our careers to &ldquo;do it right&rdquo; in all respects. 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. 
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.</div>

Manager - Primary, 2nd shift

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 This position will serve as INCOG&rsquo;s leader for managing and executing the site security program at INCOG Biopharma, a contract development and manufacturing organization (CDMO). This role ensures the safety and security of employees, visitors, facilities, intellectual property and biopharmaceutical product supporting GMP operations for its clients.
 
 
 The Site Security Manager partners cross-functionally with Operations, Quality, EH&amp;S, Facilities, People and Culture and IT to ensure security controls are effective, compliant, and aligned with business needs in a regulated biopharmaceutical manufacturing environment. This role is accountable for driving continuous improvement of site security processes, controls, and systems and delivering security enhancements that meet or exceed biopharmaceutical industry standards and best practices.
 
 
 
 Essential Job Functions:
 
 
 
 
 Site Security Operations &amp; Continuous Improvement
 
 
 
 <ul>
 <li>
 Manage day-to-day site security operations, ensuring consistent coverage and adherence to established policies and procedures.
 </li>
 <li>
 Serve as the primary site contact for all security-related matters.
 </li>
 <li>
 Maintain site security SOPs in alignment with GMP expectations and corporate standards.
 </li>
 <li>
 Proactively identify opportunities for security process improvement, risk reduction, and operational efficiency.
 
 
 
 </li>
 </ul>
 
 Physical Security &amp; Access Control
 
 
 
 <ul>
 <li>
 Oversee physical security systems including access control, CCTV, badging, alarms, and visitor management.
 </li>
 <li>
 Manage employee, contractor, and visitor access privileges based on role and authorization.
 </li>
 <li>
 Conduct routine security inspections, risk assessments, and vulnerability reviews.
 
 
 
 </li>
 </ul>
 
 GMP &amp; Client Compliance
 
 
 
 <ul>
 <li>
 Ensure security practices support GMP compliance and inspection readiness.
 </li>
 <li>
 Support regulatory inspections and client audits by providing documentation and site security walkthroughs.
 </li>
 <li>
 Partner with Quality to address security-related deviations, investigations, and CAPAs when applicable.
 
 
 
 </li>
 </ul>
 
 Incident Response &amp; Investigations
 
 
 
 <ul>
 <li>
 Lead response to security incidents, including unauthorized access, theft, safety concerns, or workplace disruptions.
 </li>
 <li>
 Conduct investigations, document findings, and implement corrective actions.
 </li>
 <li>
 Maintain incident logs and trend security events to identify improvement opportunities.
 
 
 
 </li>
 </ul>
 
 Vendor &amp; Contract Management
 
 
 
 <ul>
 <li>
 Manage contracted security services and vendors, including performance monitoring and issue resolution.
 </li>
 <li>
 Coordinate guard coverage, schedules, and post orders as required by site operations.
 </li>
 <li>
 Assist with security budget planning and cost control.
 
 
 
 </li>
 </ul>
 
 Training &amp; Awareness
 
 
 
 <ul>
 <li>
 Deliver site security orientation and awareness training for employees and contractors.
 </li>
 <li>
 Promote a strong security culture while minimizing disruption to manufacturing and laboratory operations.
 </li>
 <li>
 Provide guidance to site leadership on security best practices and emerging risks.
 
 
 
 </li>
 </ul>
 
 Emergency Preparedness
 
 
 
 <ul>
 <li>
 Support site emergency response plans and drills in coordination with EH&amp;S and Facilities.
 </li>
 <li>
 Serve as a security representative on the site emergency response or crisis management team.
 </li>
 <li>
 Coordinate with local emergency services as needed.
 
 
 
 </li>
 </ul>
 
 Special Job Requirements:
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in Security Management, Criminal Justice, Risk Management, or related field, or equivalent experience.
 </li>
 <li>
 10+ years of experience in public law enforcement or federal agencies.
 </li>
 <li>
 Experience managing physical security systems and contract security vendors.
 </li>
 <li>
 Working knowledge of GMP environments and inspection readiness.
 </li>
 <li>
 Strong incident investigation and report-writing skills.
 
 
 
 </li>
 </ul>
 
 Additional Preferences:
 
 
 
 <ul>
 <li>
 Prior site security experience within pharmaceutical, biotech, or other regulated manufacturing environments.
 </li>
 <li>
 Security certifications such as CPP, PSP, or similar.
 </li>
 <li>
 Experience supporting FDA or client audits.
 
 
 
 </li>
 </ul>
 
 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.
 
 
 
 
 By submitting your resume and details, you are declaring that the information is correct and accurate.
 
</div>

Senior Manager Site Security

Join INCOG BioPharma Services and explore 3   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

INCOG BioPharma Services

About Company

Senior Quality Process Validation Specialist

Manager - Primary, 2nd shift

Senior Manager Site Security