Sequoia Biotech Consulting

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🔥 Validation Engineer

Posted about 4 hours ago

📍 Greater Boston, San Diego, CA, Boulder, CO, India

💸 88000.0 - 110000.0 USD per year

🔍 Life sciences consulting

🔧 Requirements

Bachelor’s degree in Engineering, regulatory affairs, or a related field.
Minimum of 5-7 years of experience in validation engineering, with expertise in equipment, systems, and process validation.
Deep understanding of cGMP, FDA, EMA, and USP guidelines relevant to validation processes.
Demonstrated success in managing multiple projects in parallel.
Excellent communication skills with the ability to work effectively across departments.
Strong project management and leadership abilities.

💡 Responsibilities

Develop and execute validation protocols (IQ, OQ, PQ) for equipment, systems, and processes.
Maintain and enhance validation quality systems to ensure compliance with regulatory requirements (e.g., FDA, EMA).
Develop and improve standard operating procedures (SOPs), work instructions, and quality documentation related to validation processes.
Lead and implement change management strategies to support product lifecycle changes.
Plan, execute, and oversee validation projects from concept through implementation.
Provide technical expertise and troubleshooting support for validation-related issues.
Collaborate with cross-functional teams to align validation strategies with business objectives.

Project ManagementQuality AssuranceChange Management

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🔥 Sr. Program Manager

Posted about 4 hours ago

📍 Greater Boston, San Diego, CA, Boulder, CO, India

💸 138090.85 - 207136.27 USD per year

🔍 Life sciences consulting

🔧 Requirements

Bachelor’s degree in Engineering, Construction Management, or a related field.
Significant experience with Manufacturing Construction projects.
Proven project management and construction management experience.
Knowledge of FDA cGMP, FMEA, and Risk Analysis.
Experience in equipment installation, commissioning, and validation (IQ/OQ/PQ).
Strong budget, schedule, and vendor management skills.
Strong verbal and written communication skills.

💡 Responsibilities

Act as an onsite project manager for construction activities, ensuring work is completed per contract documents.
Provide oversight to ensure compliance with Engineering and EHS standards. Forecast and manage the project budget and schedule.
Conduct regular site walks and safety monitoring.
Run weekly core team meetings and facilitate communication between contractors and management.
Develop equipment logistics and commissioning test plans.
Oversee contractor activities, ensure adherence to quality plans, and maintain documentation.
Manage issue logs and compliance with safety meetings.

Project ManagementBudget management

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🔥 Sr. Business Excellence Program Manager (Procurement)

Posted about 4 hours ago

📍 Greater Boston, San Diego, CA, Boulder, CO, India

💸 132000.0 - 172000.0 USD per year

🔍 Life sciences consulting

🔧 Requirements

Bachelor’s or Master’s degree preferred in a related technical and/or business discipline or equivalent experience.
8-10 years of experience in developing and running programs in Procurement.
Knowledge of classical CAPEX projects, including Construction, Engineering, Equipment, Lab, Furniture, IT, and Architectural.
Dynamic program management skills with solid coaching and mentoring competency.
Ability to communicate complex concepts simply and clearly.
Self-starter, works independently, and maintains a positive, enthusiastic attitude.
Ability to work in a fast-paced environment while managing multiple priorities.

💡 Responsibilities

Develop and deploy holistic Procurement and Category Management structure for new construction projects.
Contribute to Procurement and construction goals for clients.
Develop a Procurement and Category management roadmap for multi-site projects.
Collaborate with internal and external stakeholders that interact with the program strategies and goals.

Posted about 4 hours ago

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🔥 Project Manager

Posted about 4 hours ago

📍 Greater Boston, San Diego, CA, Boulder, CO, India

💸 106991.88 - 152382.37 USD per year

🔍 Life sciences consulting

🔧 Requirements

An engineering degree (mechanical, electrical, construction).
4-9 years of experience on large, complex engineering projects.
3-5 years of relevant experience within the biotech industry.
Experience acting as owner's representative on large projects.
Experience working on multi-employer sites.
Experience from design through construction into commissioning.
Experience writing commissioning strategy/plans.
Experience supervising start-up and commissioning of equipment.
Experience coordinating equipment purchase and movement.
Experience reviewing construction site safety documents.
Experience using project/construction management software.
Experience designing and commissioning lab and office systems.
Experience writing operational and maintenance SOPs.
Experience closing out large projects and ensuring documentation.

💡 Responsibilities

Act as owner's representative on large, complex construction projects.
Work on multi-employer sites.
Take projects from design through construction and into commissioning.
Write commissioning strategy/plan and protocols for large projects.
Review technical submissions from all team members for system installation.
Answer common construction communications like RFIs and Submittals.
Supervise a large sub-contractor team for start-up and commissioning of equipment.
Coordinate the purchase, receipt, and movement of equipment.
Schedule decommissioning and movement of equipment between facilities.
Review construction site safety documents.
Walk construction sites and document observations.
Use project/construction management software.

LeadershipProject ManagementCompliance

Posted about 4 hours ago

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🔥 Program Manager

Posted about 4 hours ago

📍 Greater Boston, San Diego, CA, Boulder, CO, India

🧭 Full-Time

💸 125537.14 - 188305.7 USD per year

🔍 Pharmaceutical, Biopharma, Medical Device, Biotech

🔧 Requirements

Bachelor's degree within a life science or related field required.
10+ years of experience within the Pharma/Biopharma, Medical Device, or Biotech industry.
At least 3+ years as a project manager leading cross-functional strategic initiatives.
Experience using MS Project, Excel, PowerPoint, and Smartsheets.
Experience within a cGMP and FDA regulated environment.
Experience leading large IT programs or managing a PMO.
Strong program management experience.
Experience assisting with IT portfolio management and mobile device management.
Risk management skills related to cybersecurity are preferable.
Familiarity with Agile methodologies is also desired.
Project Management Professional (PMP) Certification preferred.

💡 Responsibilities

Develop project tasks, deliverables, dependencies, and resource requirements.
Leverage interpersonal skills to effectively navigate and drive project execution to meet project goals.
Collaborate with cross-functional groups to create, execute, and communicate overall project plans.
Assist with IT portfolio management and mobile device management.
Identify needs for changes to the plan and communicate them to ensure program goals align with business objectives.
Facilitate team meetings and workshops.
Schedule and lead phase gate reviews with an executive approval committee.
Identify and resolve or escalate program issues and facilitate trade-off decisions.
Continuously analyze and manage risks, including cybersecurity risks, for successful project completion.
Utilize appropriate tools and methodologies to manage projects and document project information.
Define and optimize project management processes to improve organizational efficiency.

Project ManagementAgileCybersecurityMS OfficeRisk ManagementPowerPoint

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🔥 Organizational Change Manager

Posted about 4 hours ago

📍 Greater Boston, San Diego, CA, Boulder, CO, India

💸 106991.88 - 152382.37 USD per year

🔍 Life sciences consulting

🔧 Requirements

Bachelor’s degree in a life science or related field.
Minimum 8-12 years of relevant experience in consulting or industry roles.
Experience with change management principles and methodologies.
Proficiency in Salesforce for managing change initiatives.
Familiarity with SAP systems is preferred.
Exceptional written and verbal communication skills.
Ability to lead planning and execution of OCM efforts.
Certified Change Management Professional or equivalent is preferred.

💡 Responsibilities

Lead one or more sub-work streams within Organizational Change Management.
Apply structured methodologies for change management activities.
Leverage change management tools to create executable plans.
Support and enable effective communication efforts across the organization.
Conduct impact analyses and assess readiness for change.
Plan and support training efforts for end users and customers.
Drive user adoption programs and enhance user experience.
Manage projects, ensuring timely and budget-compliant delivery.

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🔥 Facilities Engineer

Posted about 4 hours ago

📍 United States, India

💸 88000.0 - 107000.0 USD per year

🔍 Life sciences consulting

🔧 Requirements

Bachelor’s degree in a related field.
Minimum of 2-6 years of Project/Facilities Engineering experience, preferably in facilities background.
Process Equipment and CAPEX experience required.
GMP cleanroom experience and understanding of facility systems necessary.
Knowledge of regulatory requirements and good manufacturing practices (GMPs).
Strong skills in collaboration, communication, prioritization, and problem-solving.
Detail-oriented, highly motivated team player with good organization and initiative.

💡 Responsibilities

Schedule, coordinate, and oversee outside service providers for building maintenance.
Support verification and maintenance with building and utility systems.
Ensure completion and documentation of maintenance tasks as per policies.
Perform emergency troubleshooting and repair on HVAC and utility systems.
Inspect equipment and utilities to identify potential issues.
Maintain records of inspections and repairs for compliance and audits.
Respond to equipment failures and emergencies according to procedures.
Collaborate with other departments for effective facilities management.
Quickly troubleshoot and resolve operational issues.

Project ManagementDocumentationTroubleshooting

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🔥 Director, Business Development

Posted about 4 hours ago

🔍 Life sciences, biotechnology, diagnostic and pharmaceutical

🔧 Requirements

Bachelor’s degree required; Master's/MBA preferred.
Minimum of 5+ years managing complex clients and sales cycles in the life sciences industry.
Proven track record of business development success.
Strong communication skills with a background in selling complex solutions.
Ability to analyze market trends and translate them into strategies.

💡 Responsibilities

Develop and execute strategic territory sales plans to achieve sales growth objectives.
Qualify, sell, and close deals through a consultative sales process.
Maintain accurate records in the CRM database.
Lead the client engagement strategy and build relationships with key stakeholders.
Collaborate with technical resources to support proposals and manage transition to delivery teams.
Drive revenue growth from new and existing clients.

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🔥 Associate Facilities Engineer

Posted about 4 hours ago

📍 Greater Boston; San Diego, CA; Boulder, CO; India

💸 65000.0 - 85000.0 USD per year

🔍 Life sciences consulting

🔧 Requirements

Bachelor’s degree in a related field.
0-2 years of Project/Facilities Engineering experience or related experience.
Preferred facilities background, process equipment experience, CAPEX experience, and GMP cleanroom experience.
Demonstrated understanding of facility systems, utilities, and equipment.
Adherence to safety protocols and familiarity with regulatory requirements and GMPs.
Strong collaboration, communication, prioritization, and problem-solving skills.
Highly motivated and detail-oriented team player.

💡 Responsibilities

Schedule, coordinate, and oversee outside service providers for maintenance tasks.
Support verification and maintenance with PIDs, HVAC, electrical, and process flow diagrams.
Ensure completion and documentation of all maintenance tasks.
Perform and oversee emergency troubleshooting and repairs on various systems.
Conduct routine equipment and utility inspections to identify issues.
Maintain documented records of inspections, maintenance activities, and repairs.
Respond effectively to alarms and emergencies.
Collaborate with departments to meet facility needs.
Quickly troubleshoot and resolve system issues.
Manage time and prioritize tasks effectively.

Troubleshooting

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🔥 Sr. Process Engineer

Posted 1 day ago

📍 Greater Boston, San Diego, CA, Boulder, CO, India

🧭 Full-Time

💸 125000.0 - 156000.0 USD per year

🔍 Life sciences consulting

🔧 Requirements

Bachelor’s degree in Engineering, regulatory affairs, or a related field.
Minimum of 7-11 years of experience in pharmaceutical manufacturing and packaging.
Deep understanding of cGMP, FDA, EMA, and USP guidelines.
Proficiency with quality systems and compliance.
Strong project management and leadership abilities.
Excellent communication skills and detail-oriented.

💡 Responsibilities

Maintain and enhance manufacturing and packaging quality systems to ensure compliance with FDA, EMA, and related regulations.
Develop and improve standard operating procedures (SOPs) and work instructions related to manufacturing and packaging processes.
Lead change management strategies for manufacturing and packaging.
Manage and review equipment change requests to ensure timely and compliant updates.
Collaborate with regulatory, quality, and manufacturing teams for effective execution.
Plan and execute manufacturing and packaging projects from concept to implementation.
Identify project risks and implement mitigation strategies.
Drive continuous improvement initiatives in manufacturing and packaging processes.

Project ManagementCross-functional collaborationProcess improvement

Posted 1 day ago

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