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Role Description

Bothwell is growing and seeking a licensed electrician with cGMP experience to support a client facility in Greater Boston.

What you’ll do:

Support electrical system installation and startup, working with site electrical sub-contractors

Review documentation for electrical systems Coordinate vendors and contractors as needed

Who you are:

Active electrician license + Strong safety code knowledge + Clear communicator with strong field judgement. Preferred - Experience working within a construction environment

Bothwell consultants work directly with clients to reduce risk, improve outcomes, and keep critical facilities running.

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Role Overview: As a GxP Site Engineer at Bothwell Engineering, you will be responsible for providing technical support for GxP Facilities Operations at client site in Boston, ensuring compliance with regulatory expectations, company policies, and current procedures.

• Execute change management for manufacturing equipment and other support systems including commissioning and/or implementation of other related initiatives as assigned.
• Execute assigned duties on time and within budget; pro-actively communicate delays and other issues to relevant stakeholders.
• Manage creation and revision of protocols, reports, and engineering documents including, but not limited to, IOV, drawings, user requirement specifications and SOPs.
• Effectively work with cross departmental stakeholders to achieve departmental goals and objectives.
• Supply GEP (Good Engineering Practice) expertise drawn from own experience and/or supplemented by external resources to trouble shoot facility, equipment, or system issues.
• Balance degree of innovative exploration with pursuit of project objectives and coordinates implementation / integration of new capabilities as appropriate.

Qualifications:

• Bachelor’s degree in Engineering (Facilities Engineering, Mechanical Engineering, or a related field).
• Experience in facilities management and engineering within the life sciences sector in pharmaceutical manufacturing for 3-5 years is required.
• Strong understanding of industry standards and regulatory requirements, particularly in GxP and GMP environments.
• Excellent problem-solving skills and the ability to work independently or as part of a team.
• Flexibility to work on-site or remotely, depending on client requirements.
• Proven experience in project management, change management, and engineering documentation is a plus.

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.

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Process/Project Engineers

Job Location: 24 Knowlton Dr, Acton, MA 01720

Responsibilities:

The Project/Process Engineer is responsible for providing Engineering support for GxP Facilities Operations and ensuring the operability and reliability of GMP manufacturing process equipment located at manufacturing facilities. The role will provide technical support, including drawing review, design review, specification review, project management, change management and commissioning for GMP manufacturing equipment and facilities in a manner compliant with regulatory expectations, company policy and current procedures. This individual will also work closely with Equipment SMEs, MS&T, and equipment End Users to investigate and troubleshoot issues related to process equipment.

Specific duties include the following:

1. Execute change management for manufacturing equipment and other support systems including commissioning and/or implementation of other related initiatives as assigned;

2. Execute assigned duties on time and within budget; pro-actively communicate delays and other issues to relevant stakeholders;

3. Manage creation and revision of protocols, reports, and engineering documents including, but not limited to, IOV, drawings, user requirement specifications and SOP’s;

4. Effectively work with cross departmental stakeholders to achieve departmental goals and objectives;

5. Supply GEP (Good Engineering Practice) expertise drawn from own experience and/or supplemented by external resources to trouble shoot facility, equipment or system issues;

6. Balance degree of innovative exploration with pursuit of project objectives and coordinates implementation / integration of new capabilities as appropriate;

7. Provide direct engineering support and Subject Matter Expertise for process equipment;

8. Troubleshoot equipment to determine root cause of failure modes, independently drive failure resolution, owning Corrective/Preventative Actions and associated change controls;

9. Facilitate tech transfer, process fit, and facility fit for new projects; and

10. Generate, review, and approve of engineering change management for assigned systems.

Requirements & Qualifications:

Employer requires candidate to have a Bachelor’s in Biomedical Engineering or a closely related field and five (5) years of progressively more responsible work experience in biotech or biopharmaceutical industry in a validation engineering role or closely related occupation. Alternatively, the employer will accept a Master’s degree in Biomedical Engineering or a closely related field and three (3) years of work experience in biotech or biopharmaceutical industry in a validation engineering role or closely related occupation.

In addition, the employer requires the candidate to have the following:

1. Demonstrated knowledge of GMP (Good Manufacturing Practices), ISO (International Organization for Standards), GAMP (Good Manufacturing Automated Practices), and ANSI (American National Safety Institute) standards in GMP-regulated facilities gained through three (3) years of work experience;

2. Demonstrated knowledge of facility-related engineering disciplines (Mechanical, Electrical, and Plumbing) in a GMP manufacturing environment gained through completion of three (3) projects with a Mechanical, Electrical, and Plumbing scope; and

3. Demonstrated expertise in equipment lifecycle management including Commissioning, FAT (Factory Acceptance Test) and SAT (Site Acceptance Test), Qualification, and protocol authorship in a GMP manufacturing environment gained through three (3) years of work experience.

All years of experience may be gained concurrently.

Employee will be required to work on projects at unanticipated client sites throughout the Boston metro area. Employee will work on one project at a time. Each project will typically last at

least several months.

Salary: one hundred thirty-four thousand two hundred two dollars per year to one hundred forty-three thousand five hundred twenty dollars per year.

Applicants can send resumes to Bothwell Engineering Inc., 24 Knowlton Dr, Acton, MA 01720 or Info@bothwellengineering.com