Do you currently work in the biotech, pharma, cell or gene therapy industry? Are you a recent graduate or soon to graduate from an engineering course? We can help you find your first or next position!
We constantly seek to onboard new employees and work with independent contractors on short-term projects.
At Bothwell Engineering Inc. (BEI), our Life Science Consultants enjoy competitive benefits as full-time employees, along with numerous opportunities to work on exciting, cutting-edge projects.
We support 40+ life science sites in the Northeast with ongoing resources. Reach out with your resume and share how your expertise can help drive innovation in life-changing therapies.
Role Description
This is an in-person contract role for an I&C Electrical Engineer in Philadelphia. The position supports 200L scale gene therapy manufacturing suites, involving the design, implementation, and maintenance of control systems, process control, and instrumentation oversight. The role requires collaboration with various support areas, labs, and utilities within an expanding manufacturing facility.
Key Duties & Responsibilities
Qualifications
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Role Description
This is an in-person contract role for an I&C Electrical Engineer in the greater Boston area. The position is crucial within an expanding R&D hub of a global biopharmaceutical company. It involves providing I&C expertise for cutting-edge research and early development efforts, including advanced control system design, implementation, and maintenance for novel processes. Responsibilities include overseeing instrumentation within an innovative R&D environment and collaborating extensively with scientific teams, pilot labs, and utilities to accelerate discovery initiatives.
Key Duties & Responsibilities
Qualifications
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The Blue Mountain Asset Management (BMRAM) Consultant will assess and mitigate gaps in the Blue Mountain Asset Management System, reviewing and maintaining technical documentation related to end-to-end asset lifecycle management across all client sites. This role supports asset enrollment, calibration and maintenance scheduling, commissioning, and qualification activities. The Consultant collaborates with Facilities Engineering, Quality, Validation, and Manufacturing teams to define user requirements and functional specifications, configure BMRAM workflows, and manage user access and permissions.
The responsibilities:
• Identify, Assess and mitigate current gaps in.
• Responsible for the end-to-end lifecycle management of facility assets, including enrollment, calibration, and preventive maintenance activities per Regulatory standards to streamline asset enrollment, calibration and PM programs.
• Maintain system master data records (assets, schedules, SOPs, user roles, workflows).
• Manage user access, permissions, and security controls in compliance with company policies.
• Monitor system performance and coordinate with vendor/IT for troubleshooting. Ensure timely upgrades, and validation of new versions.
• Participate in validation activities (IQ/OQ/PQ), ensuring system compliance with 21 CFR Part 11 and data integrity standards.
• Identify opportunities to optimize workflows, generate reports/dashboards to support business needs and improve system efficiency.
• Collaborate cross-functionally with Quality, Validation, and Manufacturing teams to ensure compliance and support regulatory inspections, internal audits, and compliance readiness.
• Provide technical and documentation support for facility deviations, CAPAs, and change controls, including root cause investigations and remediation plans.
Key Skills
- Experience with BMRAM or similar asset management systems (Maximo, SAP)
- Strong knowledge of GMP regulations, calibration, and asset management principles.
- Understanding of system validation (CSV), audit trails, and data integrity principles.
- Analytical skills to interpret system data and generate reports/dashboards/matrix
Required qualifications:
- BS degree required, preferably in a science or technical area or equivalent experience
- Previous experience with forementioned responsibilities
- Demonstrate direct and indirect leadership ability
This position is onsite at the Rensselaer, IN facility.
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At Bothwell Engineering Inc., we are trusted advisors who help our clients tackle their most complex challenges. We optimize processes, ensure compliance, and drive innovation for transformative outcomes. Our team works collaboratively to bridge knowledge gaps and deliver actionable solutions that make a real impact. We pride ourselves on our deep industry connections, ensuring project success and professional satisfaction.
Work is contract-based, but hired candidates can choose to be onboard either as contractors or full-time employees, depending on their preference.
Join us for a rewarding opportunity with comprehensive benefits (401K, medical, dental, vacation, and sick days), and the chance to accelerate patients' health and contribute to meaningful life science projects.
Scroll down to apply (please indicate specific role of interest)
The Sr. Technical Writer- Clinical Mfg is responsible for performing site Non-Conformance Report (NCR), Significant SNCRs investigations, authoring CAPAs, standard operating procedures (SOPs), Clinical Batch Records, and miscellaneous technical transfer documentation as needed on site in Rensselaer, Indiana.
This role will also play a critical role supporting training for operators.
The candidate will execute these investigative tasks utilizing tools, identifying the root cause(s), documenting the results and processing the relevant records, collaborating with impacted departments to determine appropriate corrective or preventive actions, related effectiveness criteria. Functioning in an interdepartmental capacity, this individual will author Batch records and technical documentation alongside Manufacturing and Technical Transfer personnel.
Personnel filling this role will be supporting the Development and Pre-Commercial Services (DPCS) group across client site GMP facilities. The initial scope of role will be to perform duties as described with the opportunity to build a scalable organization of direct reports in the future. This candidate will site onsite at the Rensselaer, IN facility.
General Responsibilities:
Develop the scope and devise an approach for assigned CAPAs, NCRs, Batch Records and miscellaneous technical development documentation.
• Demonstrate ability to quantify data to draw conclusions to drive continuous improvement through document revisions and leadership utilizing cross functional teams.
• Provide relevant experience for training manufacturing and technical personnel both directly and indirectly
• Establish a scalable framework and organization for execution of technical and quality documentation
• Determine the Define/Measure/Analyze (problem-solving technique) elements of the investigation by utilizing investigation tools
• Identify cross-functional team members and assemble the investigation/authoring teams
• Confirm corrections/containment identified based on the investigation results
• Determine the appropriate data sources to be evaluated for the investigation and obtain the required data
· Investigate the root cause(s) of the issue and document the investigation results
• Ensure the Investigation record is maintained with current and accurate information throughout its lifecycle
• Collaborate with Action Owner/CAPA (Corrective Action and Preventive Action) Owner to develop the Action Plan/Effectiveness Plan\
• Present in Quality Review Board (QRB) stages (initiation and closure for SNCRs)
• Manage multiple investigations at any given time
• Responsible for speaking to clients and regulatory authorities to explain investigations
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Required qualifications:
• BS degree required, preferably in a science or technical area or equivalent experience
• 5+ years technical writing experience, preferably in pharmaceutical industry
• Demonstrate direct and indirect leadership ability
• Knowledge of applicable CAPA procedures, specifications, regulations and standards
• Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook) intermediate proficiency
• Goal-setting, prioritize, organization, attention to detail, and time management skills
• Critical & creative thinking and problem-solving skills
• Ability to use logic and scientific principles to reach conclusions when presented with ambiguous data
• Strong oral and written communication skills
• Ability to demonstrate strong leadership skills
• Knowledge of FDA regulations and application of Good Manufacturing Practices (GMP)
• Ability to utilize enterprise software systems (Trackwise)
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At Bothwell Engineering Inc., we are trusted advisors who help our clients tackle their most complex challenges. We optimize processes, ensure compliance, and drive innovation for transformative outcomes. Our team works collaboratively to bridge knowledge gaps and deliver actionable solutions that make a real impact. We pride ourselves on our deep industry connections, ensuring project success and professional satisfaction.
Work is contract-based, but hired candidates can choose to be onboard either as contractors or full-time employees, depending on their preference.
Join us for a rewarding opportunity with comprehensive benefits (401K, medical, dental, vacation, and sick days), and the chance to accelerate patients' health and contribute to meaningful life science projects.
Scroll down to apply (please indicate specific role of interest)
The Facilities MEP Engineering Lead is a consultant role responsible for collaborating with the project team on all aspects of a project's life cycle, including investigation, design, construction, commissioning, and document turnover.
Bothwell Engineering Inc. is a team of trusted advisors who help clients solve complex challenges. We optimize processes, ensure compliance, and drive innovation. We pride ourselves on our deep industry connections, which ensure project success and professional satisfaction.
This is a contract-based position, with the option for candidates to choose between being a contractor or a full-time employee. The role offers comprehensive benefits including 401K, medical, dental, vacation, and sick days, and provides the opportunity to contribute to meaningful life science projects that help accelerate patients' health.
The Technical Writer Consultant – Facilities will be responsible for authoring, reviewing, and maintaining high-quality technical documentation related to facilities engineering, GMP utilities, and infrastructure across all client site(s) located on site in Rensselaer, Indiana.
This includes supporting commissioning, qualification, and maintenance processes for critical systems such as HVAC, water systems, cleanroom facilities, and compressed gases. The role requires collaboration with Facilities Engineering, Quality, Validation, and Manufacturing teams to ensure all documentation meets internal standards, cGMP requirements, and regulatory expectations.
The consultant will also contribute to developing and harmonizing standard operating procedures (SOPs), change controls, work instructions, and risk assessments, ensuring inspection readiness. This candidate will sit onsite at the Rensselaer, IN facility.
General Responsibilities:
• Develop and maintain controlled documents including SOPs, work instructions, protocols, and reports for facilities engineering, GMP utilities, and equipment lifecycle management.
• Author technical assessments, engineering change controls, and risk evaluations for facility systems, ensuring alignment with cGMP, EU Annex 1, ICH, ISPE, and ASTM standards.
• Support documentation for commissioning, qualification, and maintenance activities for facility and utility systems (HVAC, RO/DI water, cleanroom infrastructure, compressed gases, etc.).
• Collaborate cross-functionally with Quality, Validation, and Manufacturing teams to ensure facility documentation supports regulatory inspections, internal audits, and compliance readiness.
• Partner with Facilities leadership to capture technical content related to capital projects, expansions, and equipment installations into clear, accurate, and inspection-ready documentation.
• Prepare and maintain standardized templates and document control practices to ensure consistency and alignment with client site quality systems (e.g., Veeva, Qualio).
• Provide documentation support for facility deviations, CAPAs, and change controls, including root cause investigations and remediation plans.
• Assist with training materials and guidance documents for facility operations and quality oversight activities.
• Ensure all documentation follows phase-appropriate regulatory expectations for both development and GMP-compliant environments
• Responsible for speaking to clients and regulatory authorities to explain investigations.
Required qualifications:
• BS degree required, preferably in a science or technical area or equivalent experience
• 5+ years technical writing experience, preferably in pharmaceutical industry
• Demonstrate direct and indirect leadership ability
• Knowledge of applicable CAPA procedures, specifications, regulations and standards
• Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook) intermediate proficiency
• Goal-setting, prioritize, organization, attention to detail, and time management skills
• Critical & creative thinking and problem-solving skills
• Ability to use logic and scientific principles to reach conclusions when presented with ambiguous data
• Strong oral and written communication skills
• Ability to demonstrate strong leadership skills
• Knowledge of FDA regulations and application of Good Manufacturing Practices (GMP)
• Ability to utilize enterprise software systems (Trackwise)
----------------------
At Bothwell Engineering Inc., we are trusted advisors who help our clients tackle their most complex challenges. We optimize processes, ensure compliance, and drive innovation for transformative outcomes. Our team works collaboratively to bridge knowledge gaps and deliver actionable solutions that make a real impact. We pride ourselves on our deep industry connections, ensuring project success and professional satisfaction.
Work is contract-based, but hired candidates can choose to be onboard either as contractors or full-time employees, depending on their preference.
Join us for a rewarding opportunity with comprehensive benefits (401K, medical, dental, vacation, and sick days), and the chance to accelerate patients' health and contribute to meaningful life science projects.
Scroll down to apply (please indicate specific role of interest)
Please fill out the following form if you are interested in working with us. We look forward to helping you find your next work opportunity!
We offer exciting opportunities and competitive compensation, which is why many of our personnel have been with us since we launched in 2011. If you have questions about the types of projects we work on or anything else, please reach out with a message!
