CDMO, CMO, Contract Development and Manufacturing Organisation

Project Engineer

Job Title
Project Engineer
Location
Germantown,  WI 53022
Other Location
Description
Summary of role
The Project Engineer is accountable for driving results in a fast-paced environment by managing multiple capital related projects, validation and is a “hands-on", on-the-floor, Project Leader, with a record of designing, and executing projects on time and within budget.  The Project Engineer works closely with cross-functional departments to understand the scope, user requirements and needs of the project and develops the project implementation plan.  The Project Engineer also reviews and designs for quality compliance, safety and adherence to company standards, developing communications and risk management plans when as necessary.  The position requires superior leadership behaviors of the Sterling core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.

Essential Functions
  • Develops project objectives working with user requirements and business plans.
  • Determines project specifications and technology and completes preliminary technical studies, determining project phases and preparing cost estimates. 
  • Participates in discussions with internal customers to determine timing for project execution and sequencing of various project milestones.
  • Establishes equipment specifications with internal customers.
  • Works with leaders to schedule and execute validation activities, identifies and resolves validation issues and designs validation test plans.
  • Authors and follows up on closure documentation for IQ, OQ and PQ.
  • Creates and reviews SOPs and related manufacturing process documentation.  Performs duties related to Corrective and Preventative Action (CAPA) plans, deviations and Change Control (CC).
  • Provides validation, facilities and utilities support for new or modified equipment used to manufacture new Active Pharmaceutical Ingredients (API).
  • Requests bids from contractors and suppliers, works the procurement group and recommends best provider.
  • Formal CAPEX document preparation and submission.
  • Controls project plan and maintains project schedule by close monitoring of project progress and coordinating activities on critical path.
  • Controls project costs by approving expenditures, administers contracts and monthly expenditures against planned cash flow.
  • Prepares project status reports.  
  • Responsible for commissioning and coordinating equipment/areas for validation. 
  • Maintains company reputation by complying with applicable federal and state regulations.
  • Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
  • An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.
Key competencies
  • Strong organizational skills and attention to detail.
  • Able to work effectively with people at all levels of the organization.
  • Ability to perform complex math functions, compute ratios, rates and percentages.
  • Ability to draw and interpret graphs and charts.
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
  • Excellent verbal and written communication and presentation skills.
  • Proficiency with Microsoft Office Software (Word, Excel, PowerPoint).
  • Proficiency with Autocad, MS Project preferred.
  • Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. 
  • Duties, responsibilities and activities may change at any time with or without notice. 
Education and Experience
  • Bachelor’s Degree in Engineering; Chemical / Mechanical / Electrical / Facility / Pharmaceutical preferred.
  • Minimum 4 years of experience in Engineering project planning/management.
  • Previous work experience in regulated Active Pharmaceutical Ingredients (API) manufacturing environment preferred.
Physical Demands and Work Environment
The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell.  The employee is frequently required to sit.  The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl.  The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.  The noise level is moderate to noisy.  Occasionally, employee may be exposed to airborne particles and fumes.  Occasionally, employee may be exposed to chemicals.  Must have the ability to wear PPE as required.  Employee occasionally may be exposed to moving mechanical parts and vibration.

Diversity and Inclusion
Sterling values diversity and we are committed to creating an inclusive environment for all employees.  All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.

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