Pharma Engineer & Validation Engineer

Company Description

Mapi Pharma is a late-stage clinical pharmaceutical company that specializes in the development of high barrier-to-entry and high added-value life cycle management products, as well as complex generic drugs. Mapi's lead product is GA Depot, a long-acting depot glatiramer acetate for treating MS. Mapi is headquartered in Israel, with R&D facilities in Israel and an API production facility and aseptic manufacturing and a large scale formulation and Fill & Finish facility for injectable Finished Dosage Forms in Jerusalem.

Role Description

A full-time on-site role for an experienced cGMP pharma engineer, for the Jerusalem site.

·         Project manager involving process, equipment and critical utilities, in a pharmaceutical cleanroom

environment.

·         Possess in-depth knowledge of aseptic and sterile production components such as compounding

systems (CIP/SIP), Isolators technology, etc.

·         End-to-end management of projects, within the company and with external suppliers, seamlessly

coordinating across various disciplines and departments.

·         Performing machine/system qualification.

·         Supervision of machine installation.

·         Comprehensive documentation creation such as: Gantt charts, URS TM (URS Vs FS) and

approval of drawings, FS, IQ, OQ, PQ, design documents, etc.

Job Qualifications:

Experience:

• Working in a cGMP environment and validation processes in the pharmaceutical industry.
• initiating, executing, and managing validation protocols and reports.

Education:

• B.Sc. or M.Sc. in mechanical engineering or equivalent field.
• Experience in medical device/pharmaceutical/biotechnological industry is an advantage.

Skills:

• Ability to work independently and collaboratively as a team player.
• Strong Attention to details, capable of multitasking and prioritizing tasks effectively in a dynamic environment.
• Proven ability to maintain composure and focus under pressure.
• Excellent communication and interpersonal skills.