Process and Equipment Engineer II

Replimune; Framingham (MA); Vor Ort; USD 148.000 - 191.500; Vollzeit

Benefits dieser Stelle

Medical insurance

Dental insurance

Vision insurance

401k match

Flexible time off

Paid holidays

Zusammenfassung

Replimune’s Process & Equipment Engineer II is responsible for GMP and non-GMP utilities and equipment engineering at the Framingham, MA site. The role provides routine engineering support for utilities, laboratory, and manufacturing equipment, and leads project engineering and validation activities as SME for the portfolio.

Based in Framingham, this position typically involves a 5‑day on‑site expectation and requires collaboration with Quality, Manufacturing, and other departments to

Qualifikationen

• Minimum BS in Chemical or Mechanical Engineering; MS preferred.
• 5–7 years in engineering, facilities or operations.
• 3+ years in a cGMP environment preferred.
• Experience with GMP utilities and equipment preferred.
• Excellent communication and technical writing skills.
• Ability to work independently or in a team.

Aufgaben

• Provide direct engineering support for site utilities and equipment; SME for associated equipment.
• Own troubleshooting, CAPA, change controls, and PM plans.
• Lead investigations with cross-functional teams and document quality records.
• Support design, procurement, installation, commissioning, and qualification of facilities/equipment.
• Ensure SOPs, cGMP, OSHA and safety standards are followed.
• Promote safety and contractor safety compliance.

Kenntnisse

Engineering experience

cGMP familiarity

Technical writing

Cross-functional collaboration

Problem solving

Ausbildung

BS in Chemical/Mechanical Eng

MS preferred

Tools

GMP equipment

Qualification/Validation

Jobbeschreibung

Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it.

At Replimune, We Live By Our Values

United: We Collaborate for a Common Goal.

Audacious: We Are Bold.

Dedicated: We Give Our Full Commitment.

Candid: We Are Honest With Each Other.

People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, a strong and evolving culture, a competitive and forward‑looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves.

Join us, as we reshape the future.

Summary Of Job Description

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.

• This position is based in our Framingham location and typically has a 5 day on-site expectation.

Key Responsibilities

• Provide direct engineering support for a portion of the site utility and equipment portfolio which includes clean utilities (Pure Steam, WFI, PW, Process Gases, etc.), HVAC systems, manufacturing process equipment and miscellaneous laboratory and support equipment. Individual will serve as the key technical subject matter expert (SME) for the associated equipment.
• Equipment ownership responsibility for the utilities, equipment and systems, which includes troubleshooting equipment to determine root cause of failure modes, owning corrective and preventative actions and associated change controls, providing input into preventative maintenance plans, assessing change controls, and continuous improvement initiatives.
• Collaborate with cross‑functional teams and/or lead investigations into equipment issues including technical writing of required quality documentation.
• Serve as key member of project teams for design, procurement and installation of new equipment and facility expansion projects. Responsibilities will include support of construction, installation, start‑up, commissioning and qualification of facilities and/or equipment.
• Ensure that all work is performed in accordance with Standard Operating Procedures (SOPs), Current Good Manufacturing Practices (cGMP), safety procedures, quality standards, Occupational Safety and Health Administration (OSHA) standards, other regulatory agency standards, and good maintenance practices.
• Promote safety within the workplace by following site safety procedures, ensuring contractors are following safety requirements, performing proactive safety assessments, and fostering a safe work culture.

Replimune is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range $148,000-$191,500. The exact base pay offered for this role will depend on various factors, including but not limited to the selected candidate’s unique set of qualifications, skills, and experience. Our current organizational needs also play a part in determining your final offer.

At Replimune, base pay is only one part of your total compensation package. The selected candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity.

Replimune also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays including year-end shutdown.

• Medical insurance
• Dental insurance
• Vision insurance
• 401k match
• Flexible time off
• Paid holidays including year-end shutdown

Other Responsibilities

• Support equipment and process related deviation investigations and change control activities.
• Assist with internal and regulatory agency audits / inspections serving as SME in discussions with internal and external auditors.
• Support equipment validation and maintenance activities to ensure utilities and equipment remain compliant with required procedures and regulations.
• Ensure training is kept in GMP compliant state.

Educational Requirements

• Minimum BS in Chemical Engineering, Mechanical Engineering or similar required, Masters in engineering preferred.

Experience And Skill Requirement

• A minimum of 5-7 years professional experience in engineering, facilities or operations.
• A minimum of three years relevant experience in a cGMP environment is preferred.
• Experience with GMP utilities and equipment is preferred.
• Excellent communication and interpersonal skills are required. Attention to detail, flexibility and technical writing skills are also important skills for this position.
• Ability to work independently or in a team environment as well as being self‑motivated and showing initiative.

About Replimune

Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV‑1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti‑tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus‑mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.

We are an Equal Opportunity Employer.