Senior Plant Services Specialist

Title: Sr. Plant Services Specialist

Date: Oct 31, 2023

Location: Sun - Billerica - Plant

Company: Sun Pharmaceutical Industries, Inc (USA)

Job Summary:
Support pharmaceutical manufacturing plant, equipment, and utilities, and maintain compliance with all state and federal guidelines with emphasis on current Good Manufacturing Practices (cGMP) and Good Documentation Practices (cGDP) requirements.

Area Of Responsibility:

• Develop and maintain electronic and paper records on pharmaceutical manufacturing equipment, utilities, and systems to maintain operations and validation
• Operate production equipment (Isolators filling line, Lyophilizer, powder filling) for setup and or production purposes as needed
• Manage execution of PMP programs consistent with cGMP engineering maintenance requirements
• Interact with and direct vendors for manufacturing improvement and plant maintenance (i.e. HVAC, Clean Utilities, trades) primary support for Security/System Monitoring/Fire System, janitorial services, and waste water certifications
• Perform non-routine and off-hours tasks as necessary
• Support area validation, calibration, certification efforts, and the transfer of new processes to the manufacturing area
• Perform equipment, utility, and plant validation as needed
• Review and update maintenance SOPs for plant, equipment, and utilities
• Follow all company policies related to job safety
• Work independently with minimal supervision using some standard procedures as well as troubleshooting and decision making
• Troubleshoot complex manufacturing equipment/plant/utility problems
• Support operations improvement and maintenance projects
• Perform improvements and maintenance as required to support all operations
• Support validation maintenance program
• Execute validations for manufacturing equipment and processes as needed
• Maintain and review records for operations plant, equipment, and utilities
• Monitor steam utility per MA State requirements
• Maintain records for waste water requirements
• Manage janitorial services and plant waste stream
• Support in the development and mentor of peers
• Monitor process operations to ensure compliance with specification
• Ensure equipment operational readiness
• Subject matter expert for multiple processing technologies (vacuum pumps, chilled water systems, autoclaves, WFI, Clean Steam)
• Other duties as assigned

Work Conditions:

• Office
• Lab
• Shop/shipping areas
• Some exposure to noise, hot and cold, outside elements, radiation exposure within allowable limits

Physical Requirements:

• Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, talk, hear, taste, smell
• Close, distance and peripheral vision; depth perception, ability to focus
• Ability to operate production equipment and hand tools
• Operate hand truck
• Operate company truck
• Current, valid Driver's license
• Operate computer/office machines
• Wear Safety shoes, safety glasses, gloves
• Lift up to 70 lbs.
• Ability to work a flexible schedule

Travel Estimate:
Up to 5%

Education and Job Qualification:

• High school diploma or equivalent required

• Technical certification preferred
• Knowledge of pharmaceutical Plant/Maintenance/manufacturing Operations or related environment
• Knowledge of aseptic techniques
• Ability to read & create engineering drawings
• State boilers “Special License to Operate” or higher preferred / obtain within 6 months of employment
• Electrician’s license preferred
• Ability to plan, prioritize and organize diversified workload
• Familiarity with use of computers and MS Office

Experience

• Minimum 3-5 years related experience
• Experience working with process equipment (compounding, vial washing, vial filling, ampoule and powder filling)
• Experience working with electronic document systems ( CMMS work orders ,LMS, Track Wise, Master Control ) or similar systems

• Experience with Building Automation Systems
• HAZMAT training
• Formal cGMP training
• Proficient with use of hand tools and power equipment
• WFI water system experiences a plus

The presently-anticipated base compensation pay range for this position is $70,380 to $86,020. 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; disability insurance; 401(k) savings plan; flexible spending accounts; 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, employee will be in an “at-will position” and 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, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives:
Sun Pharmaceuticals (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.

Job Type: Full-time

Pay: $80,000.00 - $100,000.00 per year

Benefits:

• 401(k) 4% Match
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Compensation package:

• Hourly pay
• Overtime pay
• Yearly bonus

Schedule:

• 8 hour shift
• Monday to Friday
• No weekends

Work Location: In person