Aseptic Production Operator Lead
Ferring Pharmaceuticals
This job is no longer accepting applications
See open jobs at Ferring Pharmaceuticals.See open jobs similar to "Aseptic Production Operator Lead" Ontario Bioscience Innovation Organization .Job Description:
As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our ‘people first’ philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world’s oldest enemy: disease.
As the Aseptic Production Operator Lead you will assume a senior Operator role within the aseptic manufacturing team. This position combines expert technical knowledge with leadership skills to oversee complex processes, mentor teams, and ensure the highest standards of sterility, quality, and compliance are met.
With Ferring, you will be joining a recognized leader, identified as one of “The World’s Most Innovative Companies” by Fast Company, and honored by Fortune with inclusion on its “Change the World List,” for addressing society’s unmet needs. Ferring US is also Great Places to Work® Certified, distinguishing it as one of the best companies to work for in the country.
Responsibilities:
- Lead and execute complex aseptic processing tasks, including setup, sterilization, formulation, filling, lyophilization, per work instructions, standard operating procedures and batch record process steps.
- Take charge of advanced equipment operation of aseptic processing machinery such as isolators, filling machines, lyophilizers, and autoclaves.
- .Provide mentorship, training, and guidance to junior, intermediate, and senior operators. Impart expert knowledge on aseptic techniques, equipment handling, process optimization, and compliance.
- Collaborate with cross-functional teams, including Quality Assurance, Quality Control, Engineering, and Production Management. Address deviations and drive process improvements, and ensure successful execution of aseptic processes.
- Lead and oversee aseptic process simulations, media fills, and equipment qualifications to validate process integrity, compliance, and robustness.
- Perform comprehensive in-process inspections and quality checks, ensuring the highest integrity of product quality.
- Analyze, review, and approve batch records, process data, and documentation for accuracy, compliance, and adherence to cGMP (current Good Manufacturing Practices).
- Drive continuous improvement initiatives by identifying opportunities to optimize processes, reduce waste, and enhance overall operational efficiency. Provide guidance and direction for process enhancements.
- Maintain qualification to wok within Grade A and Grade B cleaning environment and follow Standard Operating Procedures (SOPs) for gowning, cleaning, and sanitization.
- Comply with policies, guidelines, and regulatory requirements of the Quality System and applicable current Good Manufacturing Practices (cGMPs).
- Other duties as required and assigned by management.
Requirements:
- High school diploma or equivalent; technical or vocational education is preferred.
- 4+ years experience working in the pharmaceutical/biopharma/biotech industry and within aseptic clean room environments.
- Proficient in aseptic techniques, cleanroom protocols, cGMP, and regulatory requirements.
- Mastery in operating, troubleshooting, and maintaining advanced aseptic processing equipment.
- Ability to mentor, develop, and inspire operators at various experience levels.
- Exceptional attention to detail, accuracy, and documentation skills.
- Proficiency in analyzing complex process data, deviations, and implementing corrective actions.
- Exceptional communication skills, with the ability to lead and collaborate across cross-functional teams.
- Flexibility to work in shifts, including evenings, nights, weekends, and holidays, as per production schedules.
- Meet minimal visual acuity requirements necessary for quality assessments in a production or packaging environment;
- Be able to be medically cleared to wear full face tight fitting respirator based on OSHA Respiratory Protection Standard.
Physical Requirements:
- Extended periods of standing, repetitive tasks, and working within a controlled aseptic environment.
- Lifting up to 20lbs, bending, and reaching to handle equipment, materials, and products.
- Wearing mandatory personal protective equipment (PPE) such as gowns, gloves, masks, goggles, and respiratory protection as required.
Place role will be in Parsippany, NJ.
Ferring + you
At Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work. From working hours that respect your lifestyle, a culture that is welcoming and equitable, and the chance to work with the industry’s most impressive people, these are just some of the ways we live our "People First" philosophy.
Our Compensation and Benefits
At Ferring, base salary is one part of our competitive total compensation and benefits package and is determined using a salary range. The base salary range for this role is $46,265 to $110,500, which is the reasonable estimate of the base compensation for this role. The actual amount paid may differ based on non-discriminatory factors such as experience, knowledge, skills, abilities, education and primary work location. If hired to work 2nd in this role, the pay differential will be 10%. Additional compensation for this role will be provided based on competitive annual incentive compensation targets in the form of an annual bonus - payouts are based on individual and company performance.
Benefits for this role include: comprehensive healthcare (medical, dental, and vision) with a premium differential, inverse to base salary, to be paid by employees; a 401k plan and company match; short and long-term disability coverage; basic life insurance; wellness benefits; reimbursement for certain tuition expenses; sick time frontloaded yearly of 40 hours, or higher if state or local law requires; vacation time for full time employees to accrue between 112.5 and 150 hours yearly in the first four (4) years of employment, and additional accruals starting in the fifth (5th) year of employment; and 12 to 13 paid holidays per year. We are proud to offer 26 weeks of paid parental leave, learn more about the parental leave offering in our benefits package here. For roles that are not field-based, Ferring has a policy that allows employees to work up to two days from home and three at a Ferring site, weekly.
Ferring is an equal opportunity employer. All aspects of employment will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of gender, race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local laws.
Join our team and your voice will be heard, and your contributions will be valued. If you love to come up with new ways to make a positive difference and see them through, you will fit right in.
We are proud to be an Affirmative Action/Equal Opportunity Employer (including Disability/Protected Veterans). We maintain a drug-free workplace.
Location:
Parsippany, New JerseyThis job is no longer accepting applications
See open jobs at Ferring Pharmaceuticals.See open jobs similar to "Aseptic Production Operator Lead" Ontario Bioscience Innovation Organization .