Title:  Designer, MES Recipe

Driven by a bold pursuit of science and fueled by an unwavering commitment to patients, Sun Pharma is a leading global pharmaceutical company, providing high-quality medicines trusted by healthcare professionals and patients.

As part of our mission to Reach People and Touch Lives, we deliver Innovative Medicines, Generics and Consumer Healthcare products that improve the lives of millions of people. With a broadly diversified portfolio of products that span multiple therapeutic areas, we improve access to effective, affordable treatments that promote better health and well-being.

Reaching People. Touching Lives. 

Job purpose

The main responsibility of these positions will be to support the recipe design process and maintain existing electronic batch records using Manufacturing Execution System at the Brampton site. 

Duties and responsibilities

• Assist with drafting of process flow diagrams from paper-based master formulas for loading into MES.
• Design and assist other designers in the team with filling out predefined templates with data collected from various sources.
• Create Compounding Master Batch Records (MBRs) working in collaboration with Pharma Technology specialists.
• Create Packaging Generic Master Batch Records (GMBRs) and Parameter Value Lists (PVLs) working in collaboration with QA Documentation specialists.
• Support creation and maintenance of Master data, Library elements, EQM State diagrams etc. on an ongoing basis.
• Support the creation and management of equipment state diagrams and equipment cleaning/calibration specifications (ESP).
• Work with different types of MES PCS - SCADA, DCS and Historian.
• Perform when required process measurements and analysis in support of process improvements and to identify core issues (Pareto Chart, Process Flowing Mapping, Time Studies).
• Participate in coordinating system design, build, testing and validation for process improvement and GMP related software solutions.
• Support testing activities by helping with recipe testing in development environment.
• Assist with electronic recipe approvals, preparing and verifying Tractability Matrices between MES MBRs and Paper Master Formulas.
• Execute tests and qualification protocols to support implementation of new systems and installations if required.
• Provide adequate training to stakeholders pertaining to the implementation and use of MES.
• Prepare reports, user and maintenance manuals, procedures, technical specifications, and qualification protocols.
• Assist business technicians with shop floor support activities with regards to use of MES if required.
• Refine training materials such as SOP’s, training manuals and other documents based on feedback from MES specialists from various departments.
• Complete all GMP Documentation correctly and in a timely manner.
• Complete all training assignments and maintain personal training records.
• Initiate, and follow through with actions required to close Change Controls.
• Other duties as assigned.

Additional responsibility (Only applicable to customer facing roles)

Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day

Qualifications

• Recent graduate in an Engineering or Science (Computer, Chemistry etc.) discipline. 
• Solid knowledge of Manufacturing Execution Systems (MES). Werum PAS-X experience required with deep understanding or implementation skills.
• Extensive Programming or computer logic knowledge/experience preferred.
• Experience with documentation or technical writing.
• Working knowledge of database fundamentals and ERP systems.
• Knowledge of Process Control Systems and solid Project Management skills.
• Strong engineering fundamentals and problem solving skills.
• Strong listening skills and ability to pick-up details from documents.
• Knowledge of process flow and logic diagrams/drawings.
• Experience working with design or other software applications.
• Excellent written and verbal communication skills, ability to communicate and work effectively in a team-based environment.
• Experience Working knowledge of Kepware’s KEPServerEX, and other OPC servers.
• Ability to learn and utilize new software/ equipment to implement solutions.
• Knowledge of Good Manufacturing Practices.

Working conditions

• Working in the office with immediate presence on the manufacturing shop floor as required for the support.
• General working hours (9 a.m. to 5 p.m.), may be extended during time of training and special activities.
• Flexibility to be at site and varying work schedules to implement CPI initiatives at a 24/7 site.  Training assignments may involve working rotating shifts.
• Ability to work under dynamic and evolving business objectives along with emerging constraints.

Physical requirements

Office based

Direct reports

NA

This posting is for an existing vacancy.

The presently-anticipated base compensation pay range for this position is $57,000 to $71,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; RRSP savings plan; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, ethnic origin, citizenship, ancestry, sex, age, marital status, family status, physical or mental disability, gender identity, gender expression or any other ground protected by applicable human rights legislation.

The Company does not use artificial intelligence to screen, assess or select applicants.

Notice to Agency and Search Firm Representatives: Sun Pharmaceuticals Industries, Inc. (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting.  Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun.  No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.