Production Engineer I / II / Sr.

Summary of role
The Production Engineer supports cGMP manufacturing and acts as the SME for assigned programs. The Production Engineer is responsible for troubleshooting unexpected manufacturing events; preparing, conducting, and evaluating continued process verification activities; and providing on-going support of commercial manufacturing. The Production Engineer works closely with Research and Development, Manufacturing, QA and regulatory, EHS, and Engineering to ensure robust production of cGMP API materials. The position requires superior leadership behaviours of the Sterling core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.

Essential Functions

• Writes protocols and reports needed to support investigations, process changes, and equipment modifications including deviation reports, change controls, qualification protocols and report.
• Supports the creation and maintenance of cGMP production records.
• Provides training to manufacturing staff on manufacturing procedures.
• Provide technical, on the floor support of commercial and validated processes.
• Attend client call and be able to present manufacturing and programmatic updates
• “Process owner” of commercial products. Support client interactions for these products.
• Evaluate product impact of process excursions outside proven acceptable ranges.
• Seek opportunities to improve process performance within process ranges defined by large-scale equipment capabilities.
• Understand relationships between process yield and product quality to achieve process optimization as well as identify areas for optimization.
• Troubleshoots unexpected events during cGMP manufacturing, assists in investigating and documenting process deviations and CAPAs. 
• Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Complies with all company and site policies and procedures.
• 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.
• Identifies potential safety concerns within the manufacturing area and as well as opportunity to within assigned programs.
• Other duties as assigned

Key competencies

• Maintains a safe, clean and organized work environment free of safety hazards.
• Ability to work 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.
• Ability to write reports, business correspondence and procedure manuals.
• Ability to read, analyze and interpret general business periodicals, professional journals technical procedures and governmental regulations.
• Ability to effectively present information and respond to questions from groups of managers and clients.
• Basic knowledge of computers and Microsoft Office software products.
• Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.
• Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.
• Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.
• Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.
• Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.
• Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless where ideas originate. Flexible and easy to work with.
• Candidates need to be competent with IT systems, and Microsoft Office including Outlook, PowerPoint, Word and Excel.
• 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

• Requires a bachelor’s degree in engineering, Chemical Engineering strongly preferred.
• Previous work experience in a GMP regulated manufacturing environment is a plus. The level of the role (I, II, Sr.) will be aligned with the candidate’s experience.

Travel Requirement

• Up to 5% Travel required.

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 or 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.