Engineering Structures Author Login Jobs in Dedham

Security Guard is able to perform a variety of fixed-post, mobile, or foot patrols while maintaining situational awareness and making decisions and/or taking actions consistent with established post orders, facility rules, guidelines and protocols. Duties may include work in austere and uncomfortable conditions for prolonged periods of time, including periods of inclement weather, while performing walking, standing, searching, and surveillance or sitting duties essential to the performance of the security functions.

Keep supervisors and managers informed of unusual occurrences and important events as detailed in post orders, rules, regulations, guidelines, and protocols.

Monitor alarms, radio traffic and other information sources. Dispatch or inform others as needed and authorized.

Report and appropriately address fire alarms, burglary alarms, requests for assistance and criminal acts; including but not limited to: vandalism, theft, illegal entry or attempted entry, suspicious behavior, domestic or workplace violence, threats, speed or other vehicle violations, illegal drug use, inappropriate use of facility or client equipment or property.

Stop, screen, inquire, and inspect vehicles and pedestrians entering and / or exiting the facility as directed by post orders, rules, regulations, guidelines, and protocols.

Prevent passage of prohibited articles onto or from client facility.

Escort individuals or vehicles in accordance with post orders, rules, regulations, guidelines and protocols.

Use portable radios, phones, or other communication devises appropriately and according to established rules.

Monitor all APSI and client equipment; guard against loss or damage; report any such loss or damage immediately to a supervisor or manager.

Log in Property Pass numbers for authorized property/equipment movements.

Ensure the security of government property, detaining personnel, and reporting anyone involved with unauthorized property/equipment removal.

Conduct regular patrols and inspections of buildings and facilities

Issue required vehicle passes to authorize personnel.

Monitor electronic access control and report violations

Monitor radio-frequency identification (RFID) systems and respond to alarms indicating unauthorized removal of government property.

Grant access to areas during non-working hours to authorized personnel in accordance with the established procedure and access lists.

Monitor facility equipment and utility systems and report deficiencies to personnel responsible for repairs.

Perform random surveillance of buildings for the detection of unauthorized or inappropriate activity.

Perform random surveillance of fence line for breaches and the detection of unauthorized removal of government property, illegal or inappropriate activity.

Provide additional security support for scheduled events that may occur during or after duty hours or for unscheduled emergencies as requested by supervisor

Maintain activity logs and administrative documents as required by contract.

Contact, assist, and cooperate with local, state, or federal law enforcement; locate, retain, and protect necessary evidence; testify as necessary in judicial and administrative proceedings.

Other duties as assigned.

Access to government facilities/installations specific to this position is a mandatory requirement to fulfill the minimum qualifications for this position. The Government reserves the right, at its sole discretion, to deny or revoke access to the facilities/installations for reasons related to misconduct or security, with or without prior notice. If such access is denied or revoked by the Government, it will result in the termination of the employment relationship as the minimum job requirements can no longer be met.

Supervision: None

Minimum Qualifications:

1. Education: High school diploma or equivalent

2. Experience: a. Minimum of 2 years of security/civilian law enforcement experience OR an equivalent position with the United States Armed Forces (military). b. One year of work experience demonstrating the ability to follow directions, meet attendance requirements and the ability to complete the training necessary to certify with the State.

3. Must have a State of Massachusetts weapons carry permit.

4. Language: Must be fluent in speaking and writing in English.

5. Pre-Hire Screening: Must be able to pass criminal background screen, drug test and physical exam.

Preferred Qualifications:

1. First Aid/CPR certification.

2. Prior experience with the Glock platform.

3. Proficiency in basic computer skills.

4. Use of Force training.

5. Weapons proficiency.

Core Competencies:

Communication, Oral - Ability to communicate effectively with others using the spoken word.

Communication, Written - Ability to communicate in writing clearly and concisely according to strict deadlines.

Self-Motivated - Ability to be internally inspired to perform a task to the best of one's ability using his or her own drive or initiative.

Team Builder/Worker - Ability to inspire and work within a group of people to work toward a goal.

Organized - Possessing the trait of being organized or following a systematic method of performing a task.

Time Management - Ability to utilize the available time to organize and complete work within given deadlines.

Flexible - Ability to adjust to a dynamic workflow and reprioritize as project demands change.

Work Environment:

The position may require extensive sitting, watching monitors, walking around the facility outside in rain, wind or other poor weather conditions and kneeling and stooping to look under or inside vehicles or containers.

Physical Demands:

1. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

2. While performing the duties of this job the employee is frequently required to sit, talk or hear, stand, walk, use hands to handle, or operate objects, tools or controls; and reach with hands and arms. The employee is occasionally required to climb or balance; stoop, kneel, and taste or smell.

3. The employee occasionally lifts and/or moves anything from 10 to 100 pounds. Specific vision abilities required by this job includes close vision, distance vision, color vision and peripheral vision, depth perception and the ability to focus. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Schedule:

Rotating shifts, times, days as scheduled to meet the requirements of the contract (Night and weekend work required.)

Education:

Required: High School Diploma/GED or better.

Experience:

Required: 2 years: Experience: a. Minimum of 2 years of security/civilian law enforcement experience OR an equivalent position with the United States Armed Forces (military). b. One year of work experience demonstrating the ability to follow directions, meet attendance requirements and the ability to complete the training necessary to certify with the State. Must be fluent in speaking and writing in English. Must be able to pass criminal background screen, drug test and physical exam.

Licenses & Certifications:

Required: State Guard Card

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

The Director of Facilities and Grounds will provide strategic leadership and operational oversight for all Facilities, Vehicle Maintenance, and Land Operations at Juneberry Ridge. This role ensures our 750 plus acre regenerative farm, hospitality spaces, and infrastructure operate safely, efficiently, and sustainably while supporting the long-term growth of the organization.

This leader oversees two core teams, Facilities and Vehicle Maintenance and the Land Team, ensuring alignment in daily execution, asset stewardship, and long-range planning. The Director serves as a key member of the manager team, driving operational excellence, environmental stewardship, and cross departmental collaboration.

The ideal candidate is a hands-on, strategic leader with deep experience in facilities systems, land management, and team development who thrives in a dynamic, mission-driven environment.

Essential Duties and Responsibilities:

Leadership & Oversight

· Provide direct supervision and strategic guidance to the Facilities & Maintenance Lead and Land Team Supervisor.

· Develop departmental goals, staffing plans, and project schedules aligned with Juneberry Ridge's strategic vision.

· Champion a safety-first culture, ensuring compliance with OSHA standards and internal policies across all departments.

· Conduct regular team meetings, performance evaluations, and professional development planning.

· Promote environmental stewardship and operational excellence across all functions.

Operational Management

· Oversee preventative and reactive maintenance for facilities, vehicles, and equipment.

· Manage and optimize maintenance tracking and work order systems to ensure efficient scheduling, reporting, and follow-through.

· Direct land operations including landscaping, irrigation, erosion control, grading, timber management, and habitat stewardship.

· Collaborate cross-functionally (Hospitality, Farm, Events) to prioritize projects without disrupting guest experience.

· Develop and oversee farm-wide safety programs, emergency response plans, and equipment training.

· Establish and monitor key operational metrics including maintenance completion rates, equipment uptime, and resource utilization.

Financial & Resource Management

· Develop and manage departmental budgets, including materials and capital improvement planning.

· Approve and track purchase orders, invoices, and vendor payments.

· Manage contracts, service agreements, and vendor partnerships.

· Oversee asset inventory and lifecycle management for vehicles, equipment, and facilities.

Sustainability & Continuous Improvement

· Champion regenerative and sustainable practices in land care, waste management, water conservation, and energy efficiency.

· Identify and implement innovative solutions, including technology integration, fabrication opportunities, and strategic partnerships.

· Lead project planning, implementation, and long-term oversight.

Cross-Functional Collaboration

· Partner with executive leadership to plan and execute capital projects, renovations, and infrastructure upgrades.

· Support events, hospitality, and agricultural operations with logistical and technical expertise.

· Serve as point of escalation during emergencies, providing clear leadership and communication.

A Typical Day:

· Engaging across teams to identify challenges, design solutions, and actively lead implementation.

· Designing and building innovative systems and infrastructure to support a rapidly growing and evolving organization.

· Working directly toward improving ecological health indicators to restore and regenerate our 750 acres for people, animals, and the land.

Qualifications and Education Requirements:

· Associate or bachelor's degree preferred in Environmental Science, Plant Science, Ecology, Business Management, Operations, Engineering, Construction, or related field, not required.

· 7+ years of progressive experience in facilities, land management, or operations, with at least 5 years in a leadership role.

· Strong knowledge of facilities systems (HVAC, electrical, plumbing, mechanical)

· Strong knowledge of grounds/landscape maintenance and ecological land management practices.

· Proven experience managing teams across multiple disciplines (maintenance, landscaping, or equipment operations).

· Experience managing farm or workplace safety programs and ensuring regulatory compliance.

· Excellent leadership, communication, and organizational skills.

· Proficiency with Microsoft Office Suite and maintenance tracking systems.

· Ability to lift up to 50 lbs and work outdoors in variable weather conditions.

· Integrity, professionalism, and alignment with Juneberry Ridge's Mission, Vision, and Values.

DETAILS & BENEFITS

· Full-time, 45 hours per week, full benefits.

· Fully paid (no-premium) healthcare (individuals and families).

· Fully paid life insurance.

· Fully paid vision (individuals only).

· 18 PTO days + 8 recognized holidays.

Core Values at Juneberry Ridge:

· Be Joyful

· Integrity

· Pioneering

· Accountability in All We Do

· Learn, Educate, and Share

· Willful and Enthusiastic Stewardship

· Teamwork

About the Role

We’re looking for a Quality Director to lead and evolve our quality function as we scale regulated medical devices that incorporate AI/ML software. This role sits at the intersection of hardware, software, and data science and will be critical in ensuring our products meet regulatory requirements while maintaining development velocity.

You’ll report to the VP of Quality & Regulatory and work closely with Engineering, Regulatory, Clinical, and Operations. The right person for this role is comfortable in a fast-moving environment and knows how to build practical, right-sized quality systems.

What You’ll Do

Lead the Quality Function

• Own and continuously improve our Quality Management System (QMS)
• Lead and develop a small but growing quality team
• Establish KPIs and reporting for executive leadership
• Serve as the quality voice at the leadership table

Ensure Regulatory Compliance

• Maintain compliance with FDA 21 CFR Part 820, ISO 13485, and EU MDR
• Prepare for and lead FDA inspections, ISO surveillance audits, and notified body audits
• Support regulatory submissions from a quality perspective
• Monitor evolving FDA guidance on AI/ML-enabled devices and ensure alignment

Support Product Development

• Embed Design Controls into hardware and software development processes
• Ensure compliance with IEC 62304 for software lifecycle processes
• Oversee risk management activities (ISO 14971), including FMEA and hazard analysis
• Partner with Data Science teams on AI model lifecycle controls (training data management, model updates, change control, performance monitoring)

Post-Market & CAPA

• Oversee complaint handling, MDR reporting, and CAPA processes
• Drive investigations and ensure root cause analyses are thorough and actionable
• Use data trending to proactively identify quality risks

Supplier & Manufacturing Quality

• Establish and maintain supplier qualification and audit processes
• Oversee incoming inspection and production quality controls
• Partner with Operations to ensure scalable manufacturing processes

What you'll do

Experience

• 10+ years in quality roles within medical devices or regulated healthcare software
• At least 3–5 years in a leadership capacity
• Direct experience with FDA inspections and ISO 13485 audits
• Experience supporting both hardware and software products
• Familiarity with AI/ML in a regulated environment strongly preferred

Technical Knowledge

• Deep understanding of:
• FDA QSR (21 CFR 820) and ISO 13485
• ISO 14971 risk management
• IEC 62304 software lifecycle requirements
• Working knowledge of Agile/Scrum environments
• Comfort reviewing technical documentation and working closely with engineers and data scientists

Leadership Style

• Hands-on and pragmatic
• Comfortable operating in ambiguity and growth environments
• Able to push back when needed
• Strong communicator with auditors, executives, and technical teams

Nice to Have

• Experience with Software as a Medical Device (SaMD)
• Background in AI/ML model governance or data quality controls
• ASQ certification (CQE, CMQ/OE, etc.)
• Prior experience in venture-backed or scaling organizations

*2nd shift, 3-11pm*

Job Summary

The Manufacturing Supervisor provides hands-on leadership of second shift GMP manufacturing operations for microbiome Live Biologic Products. This role supervises four contract associates and ensures safe, compliant, and efficient execution of fermentation, harvest, lyophilization, media/buffer preparation, packaging, and suite readiness activities. The Supervisor serves as the primary on-site manufacturing leader during second shift and actively supports floor operations.

Responsibilities

• Supervise second shift GMP manufacturing activities, including fermentation and downstream processing.
• Lead and support four contract manufacturing associates; assign tasks and provide coaching.
• Ensure production suites, equipment, and materials are ready and compliant.
• Enforce cGMP, safety, and quality standards.
• Review batch records and documentation for accuracy and completeness.
• Execute shift schedules to meet production timelines.
• Escalate and support resolution of manufacturing issues, deviations, CAPAs, and change controls.
• Support new processes, SOP implementation, and technology transfers.
• Provide clear shift handovers and communicate production status and risks.

Qualifications

• Bachelor’s degree in Biology, Biochemistry, Engineering, or related field preferred.
• 3–6 years of GMP manufacturing experience; prior supervisory or lead experience preferred.
• Experience with fermentation, microbial processing, aseptic techniques, or lyophilization preferred.
• Strong knowledge of cGMP regulations and documentation practices.
• Experience reviewing batch records and supporting deviation management.

With more than 100 years of experience, Sika is a worldwide innovation and sustainability leader in the development and production of systems and products for commercial and residential construction, as well as the transportation, marine, automotive, and renewable energy manufacturing industries.

Sika is a specialty chemicals company with a globally leading position in the development and production of systems and products for bonding, sealing, damping, reinforcing, and protection in the building sector and industry. Sika has subsidiaries in 103 countries around the world, produces in over 400 factories, and develops innovative technologies for customers worldwide. In doing so, it plays a crucial role in enabling the transformation of the construction and transportation industries toward greater environmental compatibility. Approximately 33,000 employees generated CHF 11.20 billion in sales in 2025.

Sika is looking for an experienced Production Supervisor to join its growing team in the Canton, MA area for our Roofing business.

The A Shift Supervisor will support a team of 10 Machine Operators and will work 6am- 6pm Su, Mon, Tues and every other Wednesday.

Salary Range: $30 - $35/hour with a 10% shift differential based on education, experience and qualifications of the applicant

• Assign responsibilities to employees and oversee their development
• Ensure that employees are operating in a safe manner and that they adhere to all Sika, OSHA, and other regulatory requirements
• Periodically audit employees on their job functions and work with them to help develop their skills
• Work with management and engineering regarding coordination of raw material and process equipment trials
• Submit work orders to the Fiix CMMS system and follow through with verbal communication to maintenance technicians regarding said work orders
• Ensure that all team members are engaged in Sika Safe
• Collect daily production sheets from the Lead Operator, Mixer Operator, and Extruder Operator and document them accordingly. Reconcile any variations in MES system
• Work with quality assurance to ensure that the membrane produced meets all ASTM and local guidelines
• Foster a positive work environment through active communication and transparency with employees
• Communicate the daily/weekly production schedule with team in mandatory daily shift starter meetings
• Encourage team to maintain clean work areas using 6S principles
• Meet regularly with Production Manager and planning team to ensure that the proper materials/resources are in place for successful, on-time manufacturing
• Communicate daily results to the management team through shift report email
  
  

• 5+ years of supervisory experience in continuous manufacturing
• High School Diploma/GED
• Proficient in computers and MS Office (Word, Excel, Outlook)
• Some experience using SAP or ERP system recommended
• Excellent verbal and written communication skills
• Proven ability to work in a team environment
• The ability to coordinate product changeover on short notice
• Some extrusion, spreadcoating, and/or dry blending knowledge is preferred
• Ability to operate a forklift
• Ability to stand for extended durations
• Ability to lift 50 lbs
  
  

• 401k with Generous Company Match
• Bonuses
• Medical, Dental, and Vision Benefits
• Paid Parental Leave
• Life Insurance
• Disability Insurance
• Paid time off, paid holidays
• Floating holidays + Paid Volunteer Time
• Wellness/Fitness Reimbursements
• Education Assistance
• Professional Development Opportunities
• Employee Referral Program & More!

Sika fosters a culture of entrepreneurship, empowering each individual to make decisions, learn from experiences, and shape their own career path. The safety and well-being of employees are top priorities at Sika, with a strong commitment to open communication and maintaining a safe workplace. In addition, Sika actively contributes to the community and promotes sustainability by giving back, minimizing environmental impact, and embracing social responsibility.

Sika Corporation is committed to a work environment that supports, inspires, and respects all individuals that apply. As an equal opportunity employer Sika will consider all qualified applicants without discrimination on the basis of race, color, religion, sex, pregnancy, sexual orientation, gender identity, age, disability, national or ethnic origin, or other protected characteristics.

Sika Corporation is committed to a work environment that supports, inspires, and respects all individuals that apply. As an equal opportunity employer Sika will consider all qualified applicants without discrimination on the basis of race, color, religion, sex, pregnancy, sexual orientation, gender identity, age, disability, national or ethnic origin, or other protected characteristics.

We offer competitive salaries, aligned with local market benchmarks and the specific scope and responsibilities of each role. Compensation is determined based skills relevant to the position, education and/or training. We are committed to fair and equitable pay practices in accordance with applicable laws and regulations.

W-2 employees only. No 3rd parties.

• 8+ years in Technical Program Management, Digital Transformation, or Engineering Program Delivery.
• 3+ years leading AI/ML or advanced analytics initiatives.
• Experience in regulated industries (Pharma, Biotech, Medical Devices).
• Strong understanding of AI/ML lifecycle and data governance.
• Experience working with enterprise platforms (LIMS, MES, SAP, Veeva, etc.).
• Strong stakeholder management and executive communication skills.

Salary range: 60k - 80k

Title: Operations Associate, Facilities

Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess’ patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.

Research & development at Vaxess is cross-disciplinary, integrating mechanical, industrial, biomedical, and

chemical engineering with chemistry, biology, and human factors to address important unmet medical needs. We are seeking a talented, collaborative, and highly motivated engineer to join our growing team. This role offers a unique opportunity to build manufacturing capacity from the ground up to bring innovative technology to the global vaccine and therapeutic market. Vaxess Manufacturing Tour

Responsibilities

• Provide support for the overall lab environment, ensuring proper functioning of utilities, lab equipment and life
• safety systems
• Perform facility & safety inspections including chemical, biological and universal waste consolidation
• Perform equipment installations, qualifications and calibrations for lab & facility equipment/casework
• Provide support to various facilities administration duties including but not limited to external vendor
• coordination, landlord services, HVAC, plumbing, etc.
• Provide support to consumable, chemical and off-site storage inventories
• Collaborate closely with cross-functional teams to support product development and manufacturing activities
• Maintain necessary certifications DOT, RCRA, Bloodborne Pathogens, etc.

Qualifications

• 2-4 years’ experience as on-site technician working in an industrial R&D, Quality Control or Manufacturing lab
• Highschool Diploma/GED is required, BS in STEM degree is a plus
• Ability to lift 50 Lbs. & work across multiple sites
• Familiarity with Lab standards, compressed gas and laboratory utilities, generators, HVAC, IT & access control
• Familiarity or experience working in GxP, a cleanroom and/or a biomedical laboratory environment
• Excellent time and project management skills and proven ability to meet goals and deadlines
• Demonstrated ability to build, repair and maintain equipment, fixtures and furniture
• Demonstrated abilities to learn new skills and fields, creatively solve challenging technical problems, think
• independently, and work collaboratively in diverse multidisciplinary teams
• Entrepreneurial spirit and drive to positively impact global human health

Vaxess is building a team of exceptional people to rapidly advance product development. We work closely as a team and thrive in a dynamic, exciting, and engaging work environment. If you’re interested in joining the Vaxess team, please submit your CV/resume to

Immediate need for a talented Scientist I. This is a 12+ Months contract opportunity with long-term potential and is located in Waltham, MA, USA(Onsite). Please review the job description below and contact me ASAP if you are interested.

Job Diva ID: 26-08545

Pay Range: $ 46-$56 /hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Develop and optimize robust viral/non-viral vector purification process using advanced knowledge of column chromatography, filtration, and other downstream purification technology
• Lead and conduct viral/non-viral vector purification process development and process analytics
• Develop and optimize robust viral/non-viral vector purification process using advanced knowledge of column chromatography, filtration, and other downstream purification technology
• Develop, conduct, maintain analytical assays such as ELISA, DLS, Octet, QPCR/ddPCR, HPLC, and CE-SDS etc. for in-process sample testing to support process development
• Provide scientific and technical expertise for in-process sample testing activities, including product quality and process impurity methodologies
• Perform troubleshooting experiments and communicate findings with appropriate working groups
• Maintain industry knowledge and keep abreast of new and relevant technologies
• Perform data analysis, contribute to technical reports, external publications, patent applications and internal/external presentations
• Lead scale-up activities to implement a manufacturing process based on DSP development knowledge
• Communicate effectively with internal and external teams, e.g. CDMOs for tech transfer activities
• Mentor and support junior staff and build a culture of support and collaboration

Key Requirements and Technology Experience:

• Key skills: - Purification experience/ Protein Purification Chromatography
• Technical experience in modern analytical techniques such as spectrophotometry, ELISA, DLS, - Late-stage purification experience such as design space mapping and process robustness studies
• PhD in Biotechnology, Biochemistry, Chemical Engineering or related discipline or master’s degree with a minimum of 4 years of relevant experience or a bachelor’s degree with a minimum of 6 years of relevant experience
• Technical experience in modern analytical techniques such as spectrophotometry, ELISA, DLS, Octet, QPCR/ddPCR, HPLC, and CE-SDS
• Significant experience, knowledge and understanding of purification technologies and operations such as:
• Filtration unit operations at various scales, including depth filtration, tangential flow filtration, etc.
• Protein purification chromatography
• Virus clearance and inactivation
• Familiarity with advanced purification technologies and process analytical technologies
• Familiarity with analytical method transfer, analytical method bridging across organizations
• Experience with process technology transfers and performing gap analyses and risk assessments
• Understanding of critical quality attributes and the principles of Quality by Design and ability to apply DOE to downstream development
• Expertise in technical report writing
• Experience in AAV and/or non-viral purification development
• Experience in writing CMC components of regulatory dossiers
• Knowledge of product comparability, target product profile and quality risk assessment activities
• Viral clearance study design and execution
• Late-stage purification experience such as design space mapping and process robustness studies
• Ability to work in Biosafety Level 2, follow safe lab procedures and maintain good laboratory practices (GLPs)
• Ability to work under minimal supervision and function within a collaborative, team-oriented environment
• Excellent organization and communication skills
• Innovative, critical and creative thinker, unafraid of proposing aggressive solutions to complex problems
• Experience with biophysical characterization
• Experience in continuous manufacturing and process analytical technology
• Experience in mentoring junior staff
• Ability to build and nurture cross-functional relationships
• Ability to communicate and represent group in diverse, multi-functional meetings

Our client is a leading Pharmaceuticals industry , and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

By applying to our jobs, you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here.

About the Role

The ideal candidate has hands-on experience in Cesium chloride (CsCl) density gradient ultracentrifugation, ion-exchange chromatography, affinity purification, and tangential flow filtration (TFF), with a strong understanding of purification principles and data analysis.

Responsibilities

• Execute purification processes including CsCl density gradient ultracentrifugation, affinity chromatography (e.g., AVB, CaptureSelect), ion-exchange chromatography (AEX, CEX), and other polishing steps.
• Operate AKTA systems (Avant, Pure, or Pilot) for small- to large-scale purification runs.
• Perform TFF operations for buffer exchange and concentration of intermediate or final products.
• Support experimental design, data collection, and documentation following established procedures and GMP/GLP best practices.
• Assist in troubleshooting and optimization of purification processes.
• Analyze in-process and purified samples using relevant analytical methods (e.g., UV, SDS-PAGE, ddPCR, ELISA, or HPLC).
• Collaborate cross-functionally with upstream, analytical, and manufacturing teams.
• Maintain lab equipment, manage buffers and column inventory, and ensure compliance with safety and documentation standards.

Qualifications

• Education: Master’s degree in biology, biochemistry, chemical engineering, biotechnology, or related field.
• Experience: Minimum 2 years of hands-on purification experience in an academic or industry setting.

Required Skills

• Strong knowledge and practical experience with CsCl density gradient ultracentrifugation, ion-exchange, and affinity chromatography.
• Familiarity with buffer preparation.
• Understanding of basic analytical methods for product characterization.

Preferred Skills

• Strong attention to detail and excellent documentation habits.
• Effective communication and teamwork skills.
• Ability to manage multiple tasks and meet project timelines.

Preferred Qualifications

• Experience in AAV or other viral vector CsCl density gradient and column purification.
• Experience with AKTA systems and Unicorn software.

Hiring for GxP Systems Development Engineer in Norwood, MA

Job Title: GxP Systems Development Engineer

Location: Norwood, MA

Role Overview

The GxP Systems Development Engineer supports the implementation, upgrade, and validation of laboratory informatics systems (e.g., SDMS, LIMS, ELN) in GMP-regulated environments. This role ensures system compliance, data integrity, and seamless integration with laboratory instruments.

Key Responsibilities

• Support implementation and upgrades of LogiLab SDMS, including deployment and instrument integration
• Execute validation activities (IQ/OQ/PQ), test scripts, and traceability documentation
• Collaborate with infrastructure and validation teams for system upgrades and performance
• Perform regression testing and system verification post-upgrade
• Assist with change control and maintain validation/SOP documentation
• Ensure compliance with ALCOA+ data integrity principles
• Support UAT, issue resolution, and system optimization with cross-functional teams

Required Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field
• 3–6+ years of experience with lab systems (SDMS, LIMS, ELN, CDS) in GMP environments
• Knowledge of GxP frameworks (GAMP 5, 21 CFR Part 11, Annex 11)
• Experience with system validation (IQ/OQ/PQ) and change control processes
• Hands-on experience with system upgrades or migrations
• Understanding of lab instrument integration and digital workflows
• Strong attention to detail and collaboration skills