Process and Equipment Engineer II

The Process & Equipment Engineer II is responsible for GMP and non-GMP utilities and equipment engineering at the Framingham, MA manufacturing facility. The individual will provide routine engineering support for utilities, laboratory, and manufacturing equipment, as well as project engineering and validation support. This position will include equipment ownership responsibilities and technical expertise for a wide array of the equipment/utility portfolio serving as subject matter expert leading investigations relating to deviations in partnership with Quality, Manufacturing, and other departments.

Responsibilities

Provide direct engineering support for site utility and equipment portfolio including clean utilities, HVAC systems, manufacturing process equipment and laboratory/support equipment; Serve as key technical subject matter expert for associated equipment; Equipment ownership responsibility for utilities, equipment and systems including troubleshooting, corrective and preventative actions, change controls and continuous improvement; Collaborate with cross-functional teams and/or lead investigations into equipment issues including technical writing of quality documentation; Serve as key member of project teams for design, procurement and installation of new equipment and facility expansion projects; Support construction, installation, start-up, commissioning and qualification of facilities and/or equipment; Ensure all work is performed in accordance with SOPs, cGMP, safety procedures, quality standards, OSHA standards and good maintenance practices; Promote safety within the workplace; Support equipment and process related deviation investigations and change control activities; Assist with internal and regulatory agency audits/inspections as SME; Support equipment validation and maintenance activities; Ensure training is kept in GMP compliant state

Requirements

Minimum BS in Chemical Engineering, Mechanical Engineering or similar; A minimum of 5-7 years professional experience in engineering, facilities or operations; Excellent communication and interpersonal skills; Attention to detail, flexibility and technical writing skills; Ability to work independently or in a team environment as well as being self-motivated and showing initiative

Nice to have

Masters in engineering; Minimum three years relevant experience in a cGMP environment; Experience with GMP utilities and equipment

Benefits

Annual performance incentive bonus; New hire equity; Ongoing performance-based equity; Medical, dental, and vision insurance; 401k match; Flexible time off; Paid holidays including year-end shutdown