Process Engineer - CIP Systems Biopharmaceutical

Job Description

Job Description

Salary :

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology industries in the US & Canada.

Its services include Engineering, Project Management, and other Consulting services. MMR’s Engineering expertise includes Process, Automation, Facilities engineering.

Pharmaceutical expertise includes Oral Solid Dosage, Semi-Solids, Liquid-Dosage (TS and Aseptic), API manufacturing, Biotechnology (Vaccines, Blood Plasma Fractions, Monoclonal Antibodies).

This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers involved in the design, commissioning & qualification, start-up and project management of various processes, systems and facilities.

This role will be involved in the design, startup / shakedown, commissioning & qualification of a major greenfield facility in Raleigh, North Carolina area .

The project is expected to last 2+ years. This role requires to be permanently full time on-site in North Carolina. We offer a relocation package for anyone applying from other states.

The individual is expected to be well experienced in the startup / shakedown and commissioning of CIP systems in large pharma / biotech facilities.

Previous Pharmaceutical / Biotech experience is MANDATORY for this role.

Responsibilities

• Support startup / shakedown activities. Troubleshooting of CIP systems (CIP Skids, CIP distribution)
• Attend FATs at CIP Skid vendor facilities
• Execute C&Q protocols (SAT, IQ / OQ).
• Provide support during CIP Cycle Development & PQ
• Perform / review process engineering drawings and calculations, whether as part of engineering design or as part of verification of calculations of vendors / client / other consultants, or Junior Engineers at MMR Consulting.
• Work may require occasional support over shutdowns or extended hours, specifically during installation, commissioning, qualification and validation phases.
• You may be involved with other aspects such as client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling / budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals / opportunities), presenting at industry conferences / publishing papers etc.
• Visit construction and installation sites, wear necessary safety PPE.
• Supervise contractors during critical installations of process equipment and associated utilities.
• Travel may be required on occasion
• Other duties as assigned by client, and / or MMR, based on workload and project requirements.
• As this position requires working on client sites, you will need to comply with the client’s safety rules including mandatory vaccination policies for COVID-19, where applicable

Qualifications

• Prior experience in pharma / biotech
• Years of experience : 4-6 yrs. intermediate or 7-10+ yrs. senior level years of overall pharma process engineering experience, with at least 6 years of process engineering / C&Q experience (mix is OK) in pharma / biotech (some of which should be CIP).
• Excellent written and spoken English is required including the preparation of technical documents in English
• Experience in leading teams.
• Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity.
• Possess mentorship skills, to coach and develop junior and intermediate employees.
• Engineering degree, preferably in Chemical, Biochemical, Mechanical Engineering or a related discipline.
26 days ago