Process Engineer/Scientist - Sterile Processing

BPS Inc. is a leading process consulting and contract engineering company.  For over 10 years we have been engaged in providing project, process, engineering and validation support to top-tier pharmaceutical and biotech companies.  Currently, we are looking for a contract ENGINEER II (Associate) to support the VACCINE STERILE PROCESSING department work for one of our major pharmaceutical clients.  The initial requirement is for six months.

 

BPS Inc. offers a 401K plan and an affordable health/dental/vision plan to the correct applicant.  Four vacation days will be made available after working 3 months.





















Job Purpose

Provide technical support to aseptic (Grade A, Class 100) vaccine manufacturing operations. 

Responsibilities/Duties



The function of this position is to provide technical support to aseptic (Grade A/Class 100) manufacturing operations. This role will focus on Merck manufactured sterile pharmaceuticals and liquid and lyophilized vaccines.   The applicant will use scientific and engineering principles to investigate process deviations and execute continuous process improvements within cGMPs.  The principle responsibility areas are:



1)   Issuance and maintenance of batch manufacturing documentation.

2)   Investigation, resolution, and documentation of atypical processing events.

3)   Execution of technical projects focused on profit improvements, corrective action

      close outs, process analysis and improvements, process changes, process

      troubleshooting and component issues.

4)   Execution of cGMP compliance activities.

5)   Development of working relationships with counterparts in other areas supporting

      aseptic manufacturing, testing, and release.



Skills/Qualifications

Minimum of 3-4 years of post-Bachelors degree experience in Production, Development, Process Engineering, Technical Services or related acceptable

experience. Demonstrated ability to work both independently and as a part of a team. Proven analytical abilities.  Demonstrated written and verbal communication skills.

 

Although some required training will be provided, this position requires a person with an existing skill set who can “hit the road running”.  The ideal candidate will have some sterile manufacturing process/process engineering experience. 

 

Education

The selected applicant should have a B.S./M.S. degree in an appropriate engineering/scientific discipline (e.g. Chemical Engineering, Biochemical Engineering, Biology, Chemistry or Biochemistry).