FPC Positions Listing
job ref: FPCBA GGH 319
Project Engineer
Section 1 Job Summary

Project Engineers are primarily responsible for implementation of site capital and / or expense projects ranging in size from to over ,000K.

Section 2 Reports To

Engineering Group Leader

Section 3 Responsibilities

E&I Discipline Specific Responsibilities:
 Provide electrical and instrumentation engineering support to plant projects and to continuing and new operations
 Perform electrical and instrumentation engineering functions, such as, prepare and review electrical system drawings and specifications, instrument specifications.
 Control and supervise project electrical and instrument installations.
 Selection, design, installation and operation of electrical systems from 480 volts and below, pneumatic and intrinsically safe electrical and instrument systems.
 Insure project electrical designs are designed and implemented in accordance with NEC (Current National Electric Code)

Mechanical, Chemicals Discipline Specific Responsibilities

 Provide Mechanical and Chemical engineering support to plant projects and to continuing and new operations; assisting with process equipment specification and design functions
 Perform Mechanical and Chemical Engineering functions, such as, prepare and review process and equipment system drawings and specifications, and base identification of instrumentation requirements.
 Control and supervise mechanical installations and associated start-ups.
 Assist in selection, design, installation and operation of plant mechanical equipment.
 Ensure project mechanical systems are designed and implemented in accordance with ASME (American Society of Mechanical Engineers) and other applicable disciplinary codes.

General Project Management Responsibilities
 Start-up project installations; provide training to chemical technicians and maintenance technicians.
 Troubleshoot project installations; identify and solve operational problems.
 Identify and support means of improving site operations within area(s) of expertise.
 Development and execution of project scopes, estimates, proposals, investment applications, cost tracking spreadsheets, implementation schedules, training, SOPs, asset booking, validation and commissioning documents


Section 4 Qualifications (Education, Experience, Special Skill
Sets, Certifications, etc.)
 BS in Engineering Field of Study (or evidence of equivalent prior employment project management skill sets) (ALL)
 Good analytical skill / problem solving skills (ALL)
 Must be able to work in fast pace environment, possess good time management skills, and be a self -starter. (ALL)
 Experience with power supply systems for critical equipment. (E&I)
 Experience with classifying hazardous areas according to NEC.(E&I)
 Experience in FDA regulated facility.(ALL)
 Experience programming PLC and MMI applications. (E&I)
 Experience with batch, bulk pharmaceutical manufacturing equipment (Chem & Mech)

job ref: FPCBA GGH 211

Title: SENIOR VALIDATION ENGINEER

Accountable to: Validation Manager

Duties and Responsibilities:

 Function as project leader on specific projects.
 Must be technically competent to address detailed issues related to, but not limited to, steam-in-place, clean-in-place, mechanical functioning of equipment and systems, development of operational tests, etc.
 Responsible for interacting will all departments to meet requirements of the validation schedule.
 Individual will funnel all issues related to validation problems, findings, out-of-specification results, etc. to the appropriate party responsible for resolution.
 Responsible for working with validation contractors on a per-contract basis to ensure the requirements of the contract are satisfied.
 The Senior Validation Engineer will interact will their Department Head to ensure the overall requirements of the validation program are met.
 Miscellaneous responsibilities will also include writing, editing, revising of Standard Operating Procedures specifically related to validation activities; adherence to and potential revision of the Validation Master plan; purchase and processing of validation supplies such as thermocouple wire, biological indicators, tools, fittings, gaskets, etc.

Minimum Qualifications:

Ability To:

 Supervise and provide technical support to all phases of validation activities related to equipment, utilities, systems, operations and cleaning.
 Troubleshoot process and equipment problems and recommend solutions.
 Compile data collected in support of validation into a comprehensive package, drawing correct conclusion(s) for consolidation into comprehensive reports.

Knowledge:

 Knowledge of pharmaceutical/biotech utilities and equipment, GMP regulations and fermentation and purification processes.
 Knowledge of Kaye Validator.
Education: BS/MS in applicable field.

Experience:

 Minimum of five (5) years experience in the pharmaceutical industry working under cGMP requirements.
 Direct validation experience is required.
 Validation experience must have involved protocol development, execution and report writing.
 Experience must have included on or more of the following systems/equipment: autoclaves, fermentors, HVAC systems, water systems, cleaning validation and environmental chambers (incubators, freezers, refrigerators, cold rooms, warm rooms).


Flexibility in job description is encouraged in order to facilitate maximum efficiency.