Join Our Team
At The Catalyst Group, we have a passion for providing exceptional service to our clients and to making a difference in the live of patients around the globe. Our global network of consultants represent the best talent in the field.
We are growing and always looking to connect with exceptional people. Check out our current opportunities below and just send us a message along with your resume for consideration.
Perform various validation activities including protocol writing and process development, equipment use and assessment, technical support and associated testing / sampling in conjunction with local team and in compliance with local procedures and practices. Primarily responsible for installation, operation, and performance qualification of cleaning and sanitization methods and equipment, sterilization equipment, manufacturing and/or packaging equipment, and product mixing / compounding equipment. Some validation activity associated with computerized systems and spreadsheets. Recognize and address sterilization and/or equipment performance issues as part of the validation process. Investigate and resolve all associated non-conformances. Revise and create all associated procedural or operational documents to support commercial use of equipment in compliance with site change control and quality system requirements. Perform necessary training for site personnel on validated equipment. Encourage a continuous improvement environment and proactive safety and quality management.
- Bachelor degree in science, engineering, or related field.
- 5 years experience in validation (equipment, software, product, process) in pharmaceutical, medical device, or related industries
- Experience developing validation plans and executing validation protocols, including validation master plans
- Experience writing and editing policies and procedures, user guides, and job aids
- Experience with change control requirements and quality assurance
- Experience analyzing document sets and developing strategies and tactics for improvements
- Experience managing multiple documents/projects simultaneously
- Expertise in MS Word, MS Excel and Visio
- A thorough working knowledge and understanding of cGMPs, FDA, and pharmaceutical industry guidelines and expectations particularly related to sterilization, validation, manufacturing, labeling, cleaning and sanitization, and change control.
- Excellent written and oral communication skills and listening skills. Technical writing skills are required.
- Quickly learn complex business processes and specialized terminology
- Work both independently and collaboratively, with little supervision
- Flexible – Able to work in a changing environment with changing priorities
- Detail oriented
Senior Project Manager
The Project Manager will be accountable for execution on project timelines and overall program goals from initial concept through successful phase gates, and ultimately project closure. The PM will be responsible for identifying and resolving or escalating resource conflicts and gaps. The PM will also be responsible for integrating various project-related activities by developing, maintaining, and communicating project schedules timely and fluently.
The PM will partner with functional area leaders to identify key deliverables and will ensure cross-functional alignment and accountability. Working with these SMEs, the PM will develop strategic project plans (scope, milestones, roles & responsibilities, timing, budget, communication and interface with any external alliance or collaborator partner organizations, etc). Assist in driving decision-making using local procedures and work principles. Ensure participation in functional and cross-functional management reviews and establish and manage collaboration across team sites, as needed. Track delivery and create repositories for all project deliverables and partner with SMEs and site team leads to report project metrics. Facilitate and incorporate lessons learned, best practices, etc. Support an environment of continuous improvement.
- Bachelor of Science Degree (Engineering, Sciences, Math, Technology, or related)
- PMP Certification
- 10+ years experience in FDA regulated, cGMP industry (pharmaceutical, medical device, biologics, etc.)
- Strong project management experience and process improvement experience, with at least 10 years relevant experience leading technical services/operations, process development, and/or engineering support activities.
- Demonstrated leadership skills
- Quality Systems implementation, evolution, or management across one or multiple sites simultaneously
- Ability to provide leadership to cross-functional teams to perform technology transfers, process validation, scale-up and optimization activities
- Ability to influence at all levels of an organization.
- Excellent negotiation, facilitation, collaboration, and problem solving skills.
- Excellent interpersonal skills, and communication skills both written & verbal.
- Collaborative, diplomatic & tactful.
- Ability to efficiently deliver results.
Schedule, prepare and conduct audits in support of cGMP requirements and as directed by client. Assemble and coordinate the activities of the audit team (serve as lead auditor). Conduct audits in accordance with client standard operating procedures and quality policies. Interpret policies, standards, and regulations, and evaluate potentially critical problems not covered by policies, standards, and regulations. Exercise judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, and protocols for compliance. Appropriately escalate any critical compliance issues. Communicate audit results to client management and auditees through written audit reports and face-to-face closeout audit meetings. Manage post-audit activities and follow-up on any necessary corrective and preventive actions; resolves any conflicts. Assist with hosting regulatory facility inspections by acting as a scribe and/or document reviewer (if needed). Draft and issue periodic status reports to site management as requested. Assist with training/orientation of new Quality Auditing staff. Ability to travel both domestically and internationally.
- Bachelor of Science Degree (Engineering, Sciences, Math, Technology, or related)
- Auditor certification such as ASQ CQA, BSI, NSF, ISO or FDA
- 5+ years experience in Quality Assurance auditing (internal, supplier, corporate, compliance, etc.) with minimum one year as lead auditor
- Demonstrated leadership skills (effective communication and interpersonal skills)
- Document Management: generation, review, and approval of audit checklists, schedules, findings, and corrective actions (CAPA)
- Knowledge of US FDA CGMP, EU regulations (inc. ISO standards), Health Canada regulations required. Prefer also experience and knowledge of Japanese, Chinese, Australian, and Brazilian drug and device regulations.
- Proficient in MS Word, MS Excel, and Visio or MS Project
- Able to successfully gown into and work in ISO Class cleanroom environments (ISO 5,6,7,8)
- Proven good interpersonal skills, working with all levels of staff and clients
- Willing and able to work around biological and chemical agents as used in the drug manufacturing process
- Excellent communication and technical writing skills
- Experience in planning and conducting quality audits within designed Quality area (laboratory, research, clinical, supplier, corporate, manufacturing, distribution, quality)
UDI Validation Engineer
Perform various labeling and packaging validation activities including protocol and process development, equipment and systems use and assessment (inc. ERES, Risk Analyses), technical support and associated testing / sampling in conjunction with local team and in compliance with Unique Device Identification regulations / GS1 standards, local procedures and practices. Primarily responsible for installation, operation, and performance qualification of labeling and packaging equipment and associated software systems (CSV). Recognize and address system and/or equipment performance issues as part of the validation process. Investigate and resolve all associated non-conformances. Revise and create all associated procedural or operational documents to support commercial use of equipment in compliance with site change control and quality system requirements. Perform necessary training for site personnel on validated equipment. Encourage a continuous improvement environment and proactive safety and quality management.
Minimum 5 years experience in equipment validation in a pharmaceutical / cGMP environment.
Demonstrated industry experience and thorough understanding of Unique Device Identification (UDI) regulations and GS1 standards for labeling of Medical Devices.
Preferred education: Bachelor degree in science, engineering, or related field.
Skills: Candidate must have a thorough knowledge and understanding of cGMPs, FDA, and pharmaceutical industry guidelines and expectations particularly related to validation, change control (especially Medical Device labeling), UDI, GSI, 21 CFR part 11, and CSV. Specialized training/experience in pharmaceutical operations is a plus. Labeling and packaging equipment IQ/OQ/PQ, understanding of basic cGMPs, Risk Management, statistics, technical writing of product (DHR, DMR, BOM), process (SOP), and protocol documentation, and excellent written and verbal communication skills are required.