Process Engineer III at Planet Pharma in Portsmouth, New Hampshire

Job Description:

General Deliverables:

1. Manufacturing Support

* Develop technical knowledge on manufacturing equipment and processes

* Support resolution of major equipment breakdowns and quality issues in the suites

* Provide SME support to Manufacturing and other departments for the

* design and operation of process equipment.

* Conduct troubleshooting and technical analyses on manufacturing equipment and processes including PI data analyses, CIP/SIP circuit review, MOC analyses, flow path analyses, etc.

2. Projects

* Planning and execution of plant projects involving equipment changes and process improvements.

* Execute commissioning protocols (installation, operation, CIP/SIP, wet

* testing) with support and guidance from supervisor

3. Documentation

* Review/revise Engineering and Manufacturing related SOPs, work instructions, and maintenance assessments/procedures as a result of CAPA, equipment/process changes, error prevention activities, etc.

* Complete engineering review/approval of batch records

* Initiate EDCRs for updates to Engineering documents including engineering drawings

* Author commissioning protocols (installation, operation, CIP/SIP, wet testing).

1. Support Investigation and Implementation of Process/Equipment/Automation Design Changes as a result of new customer first run at scale runs

a. Changes driven through WorkFront

b. Own or Influence Changes driven through change controls

2. CAPEX Project Support

a. Buffer Valve Array Drain Hard Pipe

i. Submit Lump Sum Funding Request

ii. Coordinate Install Outside Piping Contractor

b. IBF to SMCC Hardpipe

i. Refine Mechanical and Automation Scope

ii. Submit funding request

iii. Draft and Own Change Request

iv. Coordinate Mechanical Design with piping contractor

v. Coordinate Automation Changes with Site Automation and Automation Contractor(s)

vi. Maintain Scope Schedule & Budget

c. SMCC Filter Housing Upgrade

i. Refine Mechanical

ii. Submit funding request

iii. Draft and Own Change Request

iv. Coordinate Mechanical Design with piping contractor

v. Coordinate Automation Changes with Site Automation and Automation Contractor(s)

vi. Maintain Scope Schedule & Budget

d. EM Conflict Resolution

i. Define Scope to remove EM conflict associated with WFI, Caustic, and Salt with associated downstream equipment

ii. Propose Mechanical Modifications (Valving) as required.

iii. Submit funding request

iv. Coordinate Automation Changes with Site Automation and Automation Contractor(s)

v. Maintain Scope Schedule & Budget

e. VRF Skid Commissioning

i. Coordinate Install of new VRF Skid with Piping Contractor

ii. Support Commissioning (process and cleaning) of new skid

• Years of Experience: 3-7 years
• Industry Experience: Biotech or Fluid Processing/Manufacturing
• Education: B.S Chemical or Mechanical Engineering

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